The DOI matches its Crossref record; 54 of the 54 references it cites were found in a registry or an index; 18 of the 46 sources its claims cite were checked for support.
Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study
Open accessAbstract
Aims/hypothesis Fenofibrate caused an acute, sustained plasma creatinine increase in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and Action to Control Cardiovascular Risk in Diabetes (ACCORD) studies. We assessed fenofibrate's renal effects overall and in a FIELD washout sub-study. Methods Type 2 diabetic patients (n = 9,795) aged 50 to 75 years were randomly assigned to fenofibrate (n = 4,895) or placebo (n = 4,900) for 5 years, after 6 weeks fenofibrate run-in. Albuminuria (urinary albumin/creatinine ratio measured at baseline, year 2 and close-out) and estimated GFR, measured four to six monthly according to the Modification of Diet in Renal Disease Study, were pre-specified endpoints. Plasma creatinine was re-measured 8 weeks after treatment cessation at close-out (washout sub-study, n = 661). Analysis was by intention-to-treat. Results During fenofibrate run-in, plasma creatinine increased by 10.0 μmol/l (p < 0.001), but quickly reversed on placebo assignment. It remained higher on fenofibrate than on placebo, but the chronic rise was slower (1.62 vs 1.89 μmol/l annually, p = 0.01), with less estimated GFR loss (1.19 vs 2.03 ml min(-1) 1.73 m(-2) annually, p < 0.001). After washout, estimated GFR had fallen less from baseline on fenofibrate (1.9 ml min(-1) 1.73 m(-2), p = 0.065) than on placebo (6.9 ml min(-1) 1.73 m(-2), p < 0.001), sparing 5.0 ml min(-1) 1.73 m(-2) (95% CI 2.3-7.7, p < 0.001). Greater preservation of estimated GFR with fenofibrate was observed with baseline hypertriacylglycerolaemia (n = 169 vs 491 without) alone, or combined with low HDL-cholesterol (n = 140 vs 520 without) and reductions of ≥ 0.48 mmol/l in triacylglycerol over the active run-in period (pre-randomisation) (n = 356 vs 303 without). Fenofibrate reduced urine albumin concentrations and hence albumin/creatinine ratio by 24% vs 11% (p < 0.001; mean difference 14% [95% CI 9-18]; p < 0.001), with 14% less progression and 18% more albuminuria regression (p < 0.001) than in participants on placebo. End-stage renal event frequency was similar (n = 21 vs 26, p = 0.48). Conclusions/interpretation Fenofibrate reduced albuminuria and slowed estimated GFR loss over 5 years, despite initially and reversibly increasing plasma creatinine. Fenofibrate may delay albuminuria and GFR impairment in type 2 diabetes patients. Confirmatory studies are merited. Trial registration ISRCTN64783481.
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Written from the paper’s full text.
TL;DR
In the FIELD trial, fenofibrate caused an acute, reversible rise in plasma creatinine but over 5 years reduced albuminuria and slowed estimated GFR loss compared with placebo. Washout data suggested fenofibrate may delay albuminuria and GFR impairment in type 2 diabetes, and confirmatory studies were said to be merited.
Key findings
- During the 6-week fenofibrate run-in, plasma creatinine increased by 10.0 μmol/l (p<0.001) and reversed on placebo assignment; the chronic creatinine rise was slower with fenofibrate than placebo (1.62 vs 1.89 μmol/l annually, p=0.01), with less estimated GFR loss (1.19 vs 2.03 ml min⁻¹ 1.73 m⁻² annually, p<0.001).
- In the washout sub-study (n=661), estimated GFR fell less from baseline on fenofibrate (1.9 ml min⁻¹ 1.73 m⁻², p=0.065) than on placebo (6.9 ml min⁻¹ 1.73 m⁻², p<0.001), sparing 5.0 ml min⁻¹ 1.73 m⁻² (95% CI 2.3–7.7, p<0.001).
- Fenofibrate reduced urinary albumin/creatinine ratio by 23.7% vs 11.5% (mean difference 13.9% [95% CI 9.2–18.3], p<0.001), with 14% less progression and 18% more regression of albuminuria (p<0.001); end-stage renal event frequency was similar (21 vs 26, p=0.48).
- Greater estimated GFR preservation with fenofibrate was seen with baseline hypertriacylglycerolaemia alone or combined with low HDL-cholesterol, and with reductions of ≥0.48 mmol/l in triacylglycerol over active run-in.
Methods
- Randomised, double-blind, placebo-controlled FIELD trial: 9,795 type 2 diabetes patients aged 50–75 years at 63 sites in Australia, New Zealand and Finland were assigned fenofibrate 200 mg daily (n=4,895) or placebo (n=4,900) for about 5 years, after a 16-week run-in including 6 weeks of single-blind fenofibrate.
- Pre-specified renal endpoints were renal function changes, urinary albumin/creatinine ratio changes, and end-stage renal disease; estimated GFR used the MDRD four-variable formula, plasma creatinine was measured four- to six-monthly, and albuminuria was measured at baseline, year 2 and close-out.
- A washout sub-study re-measured plasma creatinine 52±13 days after close-out in 661 participants; analysis was intention-to-treat, using t tests, Wilcoxon rank-sum tests, χ² tests, linear models and interaction tests, with two-sided p<0.05 unadjusted for multiple comparisons.
Limitations
- The paper states the washout sub-study was relatively small, estimated GFR has limitations and inulin/PAH clearance is impractical in large trials, urinary ACR was measured less often than plasma creatinine, and cystatin C was not measured in FIELD.
- The paper states that analyses relating changes in estimated GFR from baseline to washout according to baseline characteristics and run-in biomarker changes were post hoc; it also reports that p values were unadjusted for multiple comparisons.
- The text notes possible indication bias for renin-angiotensin system blocker use and that greater statin/renin-angiotensin system blocker initiation in the placebo arm may have led to underestimation of fenofibrate’s renal benefit; the sex subgroup finding was post hoc.
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Claims the paper makes
73 Own result · 28 Own method · 17 No full text of the sources · 16 Own interpretation · 9 Supported · 6 Partly supported · 3 No basis given · 2 Supported so far · accuracy not yet measured
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Fenofibrate caused an acute, sustained plasma creatinine increase in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and Action to Control Cardiovascular Risk in Diabetes (ACCORD) studies.”
- Also stated in: § Introduction · plain
“Two recent large-scale, double-blind, randomised, placebocontrolled clinical trials, Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and Action to Control Cardiovascular Risk in Diabetes (ACCORD), have shown an early, sustained rise in serum creatinine with fenofibrate in patients with type 2 diabetes [1,2].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Abstract
What the sources say
- Not checked — no full text of the sourcecites [1] The FIELD Study Investigators (2005) Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD Study): randomised controlled trial. Lancet 366:1849–1861 source
- Partly supportedcites [2] The ACCORD Study Group (2010) Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 362:1563–1574 sourceExperimental — accuracy not yet measured
The Results > Safety passage reports that serum creatinine rose in the ACCORD fenofibrate group within the first year and remained relatively stable thereafter. It says increases were also noted in other fenofibrate trials, citing FIELD, but does not establish that the rise in FIELD had the same acute, sustained course. Page numbers are unavailable in our copy. (LLM, conf=0.82)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Also stated in: § Introduction · plain
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“The rise appears to be partly due to a decrease in creatinine clearance [16,21] without reduced inulinderived GFR [16,24]”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [16] Ansquer J-C, Dalton RN, Causse E, Crimet D, Malicot KL, Foucher C (2008) Effect of fenofibrate on kidney function: a 6-week randomized crossover trial in healthy people. Am J Kidney Dis 51:904–913 source
- Supportedcites [21] Forsblom C, Hiukka A, Leinonen E, Sundvall J, Groop PH, Taskinen M-R (2010) Effects of long-term fenofibrate treatment on markers of renal function in type 2 diabetes: FIELD Helsinki Substudy. Diab Care 33:215–220 source
This paper supports the creatinine-clearance portion of the sentence, which cites it alongside [16]. Its Results report increased plasma creatinine and decreased creatinine clearance with fenofibrate, and its Conclusions say reduced clearance could account for the creatinine rise. The separate inulin-derived GFR portion cites [16,24], not this paper. (LLM, conf=0.88)
- Not matchedcites [24] Hottelart C, Esper NE, Achard JM, Pruna A, Fournier A (1999) Fenofibrate increases blood creatinine, but does not change the glomerular filtration rate in patients with mild renal insufficiency. Néphrologie 20:41–44
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Every source the paper cites for this claim was checked and supports it.
In the paper
“In FIELD, there was evidence that fenofibrate had significant beneficial effects on laser treatment for diabetic retinopathy [4] and lower limb amputations, including in instances regarded as having a predominantly microvascular aetiology [5].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Supportedcites [5] Rajamani K, Colman PG, Li LP et al (2009) Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD Study): a prespecified analysis of a randomised controlled trial. Lancet 373:1780–1788 source
The Discussion reports substantially fewer overall amputations in the fenofibrate group and a significant reduction in minor amputations without large-vessel disease. The Methods (Procedures) say those minor amputations were judged to be related to microvascular disease. The claim accurately reflects both findings. (LLM, conf=0.93)
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Re-analysis of our data using an estimated GFR formula (EPI-CKD) with greater accuracy at higher estimated GFR levels [44] did not alter our conclusions (slightly smaller but still significant benefit [data not shown]).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Supportedcites [44] Levey AS, Stevens LA, Schmid CH et al (2009) A new equation to estimate glomerular filtration Rate. Ann Intern Med 150:604–612 source
The citation supports the description of the CKD-EPI equation, not the citing authors’ statement about re-analysing their own data. The source paper’s Discussion says the equation has lower bias especially at estimated GFR above 60 mL/min/1.73 m², and its Results report better accuracy than the MDRD equation, especially at higher GFR. The unchanged conclusions are the citing authors’ own finding. (LLM, conf=0.93)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“which is similar to progression rates in the UK Prospective Diabetes Study (2.5%) and the Microalbuminuria, Cardiovascular, and Renal Outcomes-Heart Outcomes Prevention Evaluation (MICRO-HOPE) Study (2.2%) [40,41].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Partly supportedcites [40] Retnakaran R, Cull CA, Thorne KI, Adler AI, Holman RR, for the UKPDS Study Group (2006) Risk factors for renal dysfunction in type 2 diabetes. UKPDS 74. Diabetes 55:1832–1839 sourceExperimental — accuracy not yet measured
The paper’s introductory passage reports that 24.9% of UKPDS patients developed microalbuminuria within 10 years and that annual transitions between successive renal stages were 2–3%. This is consistent with an approximate 2.5% annual rate, but the paper does not state a 2.5% annual rate for progression to either micro- or macroalbuminuria. The FIELD and MICRO-HOPE figures are not attributed to this source by the citing sentence. (LLM, conf=0.83)
- Not checked — no full text of the sourcecites [41] Gerstein HC, Yusuf S, Mann JFE et al (2000) Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE Substudy. Lancet 355:253–259 source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Renal assessment through inulin and p-amino hippurate clearance is impractical in large trials and estimated GFR has limitations [13].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Partly supportedcites [13] Chudleigh RA, Dunseath G, Evans W et al (2007) How reliable is estimation of glomerular filtration rate at diagnosis of type 2 diabetes? Diab Care 30:300–305 sourceExperimental — accuracy not yet measured
The Results section says eGFR has significant limitations, supporting that part of the citing sentence. The Clinical and Laboratory methods describe measurement using 51Cr-EDTA, but our copy does not say that inulin and p-amino hippurate clearance are impractical in large trials. Searches for those clearance methods and for the practicality of direct GFR measurement found no supporting passage. (LLM, conf=0.84)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“It remained higher on fenofibrate than on placebo, but the chronic rise was slower (1.62 vs 1.89 μmol/l annually, p=0.01), with less estimated GFR loss (1.19 vs 2.03 ml min -1 1.73 m -2 annually, p<0.001).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Abstract
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“It remained higher on fenofibrate than on placebo, but the chronic rise was slower (1.62 vs 1.89 μmol/l annually, p=0.01), with less estimated GFR loss (1.19 vs 2.03 ml min -1 1.73 m -2 annually, p<0.001).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Abstract
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In participants allocated fenofibrate, plasma creatinine remained 10 to 12 μmol/l higher than placebo (p<0.001;Fig. 2a), with an apparently greater fall in estimated GFR (87.6 to 70.5 vs 87.8 to 79.9 ml min -1 1.73 m -2 ) from prerun-in (baseline) to close-out.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Greater preservation of estimated GFR with fenofibrate was observed with baseline hypertriacylglycerolaemia (n=169 vs 491 without) alone, or combined with low HDL-cholesterol (n=140 vs 520 without) and reductions of ≥0.48 mmol/l in triacylglycerol over the active run-in period (pre-randomisation) (n=356 vs 303 without).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Abstract
plaindirectn = 140- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Probably not a substantial claim. 33
- It may state two separate claims as one. 35
Every source the paper cites for this claim was checked and supports it.
In the paper
“Although estimated GFR may underestimate true glomerular filtration rate [13], particularly at >90 ml min -1 1.73 m -2 , our analyses focused on changes over time and between treatments, rather than absolute values.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
What the sources say
- Supportedcites [13] Chudleigh RA, Dunseath G, Evans W et al (2007) How reliable is estimation of glomerular filtration rate at diagnosis of type 2 diabetes? Diab Care 30:300–305 source
The Conclusions state that both Cockcroft–Gault and MDRD estimates significantly underestimated isotopically measured GFR in newly diagnosed patients with type 2 diabetes, particularly when measured GFR was at least 90 ml/min per 1.73 m². This supports the citing sentence’s hedged claim in the population studied. (LLM, conf=0.94)
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“Fenofibrate has been shown to decrease albuminuria in a mouse model of type 2 diabetes [10] and in humans [1,2,11].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Introduction
What the sources say
- Supportedcites [10] Park CW, Zhang Y, Zhang X et al (2006) PPARalpha agonist fenofibrate improves diabetic nephropathy in db/db mice. Kidney Int 69:1511–1517 source
Citation [10] supports the mouse-model clause; the human clause is attributed to other citations. In “Urine volume and albuminuria,” the paper reports that fenofibrate reduced urinary albumin excretion in type 2 diabetic db/db mice. Page numbers were not provided. (LLM, conf=0.94)
- Not checked — no full text of the sourcecites [1] The FIELD Study Investigators (2005) Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD Study): randomised controlled trial. Lancet 366:1849–1861 source
- Supportedcites [2] The ACCORD Study Group (2010) Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 362:1563–1574 source
The Discussion reports reduced microalbuminuria and macroalbuminuria in the fenofibrate group. This supports the human finding for which this paper is cited; the mouse-model finding is attributed to a different citation. (LLM, conf=0.92)
- Not checked — no full text of the sourcecites [11] Ansquer J-C, Foucher C, Rattier S, Taskinen M-R, Steiner G (2005) Fenofibrate reduces progression to microalbuminuria over 3 years in a placebo-controlled study in type 2 diabetes: results from the Diabetes Atherosclerosis Intervention Study (DAIS). Am J Kidney Dis 45:485–493 source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Despite multifactorial treatment in the STENO-2 trial, renal disease still developed in 25% of patients over 13 years [15].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Supportedcites [15] Gaede P, Lund-Andersen H, Parving H-H, Pedersen O (2008) Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 358:580–591 source
The Results (p. 586) report that diabetic nephropathy developed in 20 patients in the intensive-therapy group during the entire observation period. The Study Design says 80 patients were assigned to that group, making 20 of 80 equal to 25%; the paper describes the follow-up as 13.3 years. (LLM, conf=0.92)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Interestingly, fenofibrate use in a mouse model of type 2 diabetes was linked with reduction in albuminuria, as well as histopathological improvements, e.g.reduced glomerular hypertrophy and reduced mesangial expansion [10].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Supportedcites [10] Park CW, Zhang Y, Zhang X et al (2006) PPARalpha agonist fenofibrate improves diabetic nephropathy in db/db mice. Kidney Int 69:1511–1517 source
The Discussion reports that fenofibrate reduced urinary albumin excretion and improved renal histopathology in type II diabetic db/db mice, including reduced glomerular hypertrophy and mesangial matrix expansion. The urine volume and albuminuria section also reports persistently reduced albuminuria during treatment. (LLM, conf=0.95)
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The ACCORD Lipid trial, which examined patients on a background of statin treatment and high use of renin-angiotensin system blockade, recently confirmed our finding that fenofibrate caused an acute plasma creatinine rise and long-term reduction of micro-and macroalbuminuria, with no adverse effect on end-stage renal disease compared with placebo [1,2].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [1] The FIELD Study Investigators (2005) Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD Study): randomised controlled trial. Lancet 366:1849–1861 source
- Partly supportedcites [2] The ACCORD Study Group (2010) Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 362:1563–1574 sourceExperimental — accuracy not yet measured
The Results (Safety; page unavailable) report an early rise in serum creatinine with fenofibrate and no significant between-group difference in end-stage renal disease or hemodialysis. The Discussion (page unavailable) reports reductions in both microalbuminuria and macroalbuminuria. The Methods confirm background simvastatin treatment, but the passages found do not establish the citing sentence’s additional claim of high renin–angiotensin system blockade use. (LLM, conf=0.85)
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
Every source the paper cites for this claim was checked and supports it.
In the paper
“However, the study had no washout phase and was therefore not able to unmask the underlying GFR preservation demonstrated now by us.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Supportedcites [21] Forsblom C, Hiukka A, Leinonen E, Sundvall J, Groop PH, Taskinen M-R (2010) Effects of long-term fenofibrate treatment on markers of renal function in type 2 diabetes: FIELD Helsinki Substudy. Diab Care 33:215–220 source
Research Design and Methods describes five years of fenofibrate or placebo treatment, and Laboratory Analyses places the baseline examination before treatment; the reported assessments do not include a post-treatment washout. The Conclusions say the available data cannot establish the significance of the treatment-related renal-marker changes. The GFR preservation 'demonstrated now by us' is the citing authors’ own finding, not one attributed to this source. Page numbers were not available in our copy. (LLM, conf=0.84)
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“They also found a greater fall in estimated GFR in patients allocated fenofibrate compared with placebo, in keeping with our on-study findings.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Supportedcites [21] Forsblom C, Hiukka A, Leinonen E, Sundvall J, Groop PH, Taskinen M-R (2010) Effects of long-term fenofibrate treatment on markers of renal function in type 2 diabetes: FIELD Helsinki Substudy. Diab Care 33:215–220 source
The Abstract Results report significant decreases in estimated GFR during fenofibrate treatment. The Conclusions state that fenofibrate reduced several measures of renal function more than placebo and describe a more modest eGFR reduction in the placebo group. Our copy provides no page number for these passages. (LLM, conf=0.93)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Renal assessment through inulin and p-amino hippurate clearance is impractical in large trials and estimated GFR has limitations [13].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Supportedcites [13] Chudleigh RA, Dunseath G, Evans W et al (2007) How reliable is estimation of glomerular filtration rate at diagnosis of type 2 diabetes? Diab Care 30:300–305 source
The Abstract concludes that the Cockcroft–Gault and MDRD equations significantly underestimate measured GFR in newly diagnosed patients with type 2 diabetes, particularly those with preserved renal function. The Conclusions also explicitly describe significant limitations of eGFR outside the setting of chronic kidney disease. The cited paper therefore supports the attributed statement that estimated GFR has limitations. (LLM, conf=0.94)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“but has been shown in animals and humans to be reno-protective [35]”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Partly supportedcites [35] Muntner P, Coresh J, Smith JC, Eckfeldt J, Klag MJ (2000) Plasma lipids and risk of developing renal dysfunction: the Atherosclerosis Risk in Communities Study. Kidney Int 58:293–301 sourceExperimental — accuracy not yet measured
The Results passage (page unavailable in our copy) associates higher HDL cholesterol with a lower risk of a rise in creatinine in humans, but this observational finding does not show that HDL itself protects the kidney. The paper’s discussion of animal models reports reduced renal injury after lipid-lowering treatment, not a protective effect specifically attributable to HDL. (LLM, conf=0.87)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Implications for cardiovascular protection may be relatively small for normoalbuminuric patients, but are greater for those with macroalbuminuria (ESM Fig. 2) [9]”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Partly supportedcites [9] Drury P, Ting R, Zannino D et al. (2010) Estimated glomerular filtration rate and albuminuria are independent predictors of cardiovascular events and death in type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia. doi: 10.1007/s00125-010-1854-1 sourceExperimental — accuracy not yet measured
The Clinical outcomes section reports higher cardiovascular risk with albuminuria than without it, and the Discussion identifies macroalbuminuria as a marker of roughly doubled CVD risk. That supports a possible greater need for cardiovascular protection, but not a greater protective effect of treatment: the paper reports no significant treatment-by-albuminuria subgroup interaction. Page numbers were not available in our copy. (LLM, conf=0.82)
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“A very similar rise in serum cystatin C was also demonstrated in the Helsinki sub-study [21], but measurements were not repeated after treatment withdrawal.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Supportedcites [21] Forsblom C, Hiukka A, Leinonen E, Sundvall J, Groop PH, Taskinen M-R (2010) Effects of long-term fenofibrate treatment on markers of renal function in type 2 diabetes: FIELD Helsinki Substudy. Diab Care 33:215–220 source
The paper identifies itself as the FIELD Helsinki substudy (Conclusions). Its Results report that cystatin C rose by 14.1% in the fenofibrate group, compared with 3.6% in the placebo group (P < 0.001). (LLM, conf=0.93)
boostedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In the same group, estimated GFR fell proportionately and below 90 ml min -1 1.73 m -2 at a rate of approximately 5% per annum.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plainn = 4,900- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This reflected a 5-year fall in estimated GFR of 1.9 ml min -1 1.73 m -2 in the fenofibrate group (from 89.2 to 87.3; p=0.07) vs 6.9 ml min -1 1.73 m -2 in the placebo group (from 87.5 to 80.6; p<0.001), such that fenofibrate spared an average of 5.0 ml min -1 1.73 m -2 (p<0.001) or ~1 ml min -1 1.73 m -2 annually (Fig. 3b).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plaindirectn = 661 ·- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Benefit also differed by treatment response according to the extent of plasma triacylglycerol lowering with fenofibrate (during active run-in), being observed continuously (p=0.002) and categorically (p=0.02 for interaction; ESM Table 3), but independently of all other variables (including other baseline lipids, blood pressure and renin-angiotensin system blocker use; Fig. 4) and on-study commenc”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“estimated GFR preservation was greater in patients with baseline dyslipidaemia and greater fenofibrate-related plasma triacylglycerol reduction.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“These benefits were similar for all subgroups (including reninangiotensin system blocker use), except sex, with larger effects among men than women (post hoc analysis, data not shown).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The mean annual rates of plasma creatinine rise and estimated GFR decline were 1.62 vs 1.89 μmol/l and 1.19 vs 2.03 ml min -1 1.73 m -2 respectively for patients on fenofibrate vs those on placebo.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A fall in urinary creatinine concentration was observed with fenofibrate, but this was exceeded by the decrease in urinary albumin concentration, reducing the ratio.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This equated to a 0.2 mg/mmol difference in mean ACR at close-out (fenofibrate 1.1 vs placebo 1.3 mg/mmol), reflecting 11.7, 1.0 and 0.1 mg/mmol differences among macro-, microand normoalbuminuric participants respectively (ESM Fig. 2).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A shift across categories occurred, favouring fenofibrate, with 14% less progression (11.1% vs 12.9%) and 18% more regression (11.2% vs 9.5%; p<0.001;ESM Table 4).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Fenofibrate benefits were independent of blood pressure despite an associated lowering of systolic BP by approximately 2 mmHg.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This protection was observed across most subgroups and was irrespective of baseline or on-study commencement of renin-angiotensin system blockers.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In the FIELD study, the number needed to treat to prevent one patient worsening by at least one estimated GFR grouping (<30, 30 to <60, 60 to <90 or ≥90 ml min -1 1.73 m -2 ) was 25 and only 10 for dyslipidaemic patients.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Eligibility was confirmed during run-in independently of adherence or biochemical changes.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Methods
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“A telephone computer randomisation service using dynamic balancing to stratify patients by prognostic variables was used.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“All investigators, except the authorised study statistician, were masked to treatment allocation before and after randomisation.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“All measurements of albuminuria and creatinine were performed in the central laboratories with regular quality assurance through participation in national schemes.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Two-sided p values were significant at p<0.05 and were unadjusted for multiple comparisons.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Statistical analysis
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Albuminuria (urinary albumin/creatinine ratio measured at baseline, year 2 and close-out) and estimated GFR, measured four to six monthly according to the Modification of Diet in Renal Disease Study, were pre-specified endpoints.”
- Also stated in: § Randomisation and interventions · plain
“Pre-specified renal endpoints were: (1) renal function changes; (2) urinary albumin: creatinine ratio (ACR) changes; and (3) end-stage renal disease, defined as plasma creatinine >400 μmol/l, dialysis, transplant or renal disease death.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
- Also stated in: § Randomisation and interventions · plain
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“FIELD was a randomised, double-blind placebo controlled trial with the primary outcome of coronary events.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Methods
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Plasma creatinine was measured by the Jaffe reaction (alkaline picrate-kinetic) on a clinical chemistry analyser (Hitachi 917; Roche Diagnostics, Basel, Switzerland), using calibrators supplied by the manufacturer, with interassay CVs over 5 years of 1.3% at a concentration of 170 μmol/l and 1.9% at 600 μmol/l.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Analysis was by intention-to-treat.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Urine albumin was measured by immunonephelometry on an analyser (Array 360; Beckman, Fullerton, CA, USA), with interassay CVs over 5 years of 2.8% at a concentration of 10 mg/l and 2.5% at 50 mg/l.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“This definition was revised to be sex-specific after the study was unmasked.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Rests on an assumption: The revision of the albuminuria definition after unmasking did not bias the albuminuria results.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“In analyses pre-specified 6 months prior to unmasking of the study, 661 patients were re-assessed 52±13 days after close-out to further evaluate the known fenofibrate-associated changes in plasma creatinine.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plainn = 661- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Fenofibrate reduced albuminuria and slowed estimated GFR loss over 5 years, despite initially and reversibly increasing plasma creatinine.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Abstract
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“This registered study had ethics committee approval in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Methods
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“All patients provided written informed consent and then completed a 16 week run-in period comprising 4 weeks of diet, 6 weeks of single-blind placebo and 6 weeks of single-blind fenofibrate.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Methods
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“They had similar baseline characteristics to non-participants and balanced characteristics by treatment allocation (Electronic supplementary material [ESM] Table 1).”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plainn = 661- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“This method showed excellent agreement with isotope-dilution mass spectrometry and recovered the certified values assigned to the reference material.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Randomisation and interventions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Only the analyses relating to changes in estimated GFR from baseline to the end of the washout period according to baseline characteristics and changes in biomarkers during active run-in were post hoc, in that the associations between the prespecified variables and the pre-specified outcomes were not expressly stated in the statistical analysis plan.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Statistical analysis
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“These effects can be differentiated through a washout study, without which structural preservation may be missed [18].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [18] Heerspink HL, de Zeeuw D (2010) Composite renal endpoints: was ACCOMPLISH accomplished? Lancet 375:1140–1142 source
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“Hottelart et al. demonstrated increased creatinuria with no fall in creatinine clearance [25].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [25] Hottelart C, Esper NE, Rose F, Achard J-M, Fournier A (2002) Fenofibrate increases creatinemia by increasing metabolic production of creatinine. Nephron 92:536–541 source
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Fenofibrate effects on renal plasma flow in these two studies were also contrasting [16,25], but both concluded there was no loss of glomerular function.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [16] Ansquer J-C, Dalton RN, Causse E, Crimet D, Malicot KL, Foucher C (2008) Effect of fenofibrate on kidney function: a 6-week randomized crossover trial in healthy people. Am J Kidney Dis 51:904–913 source
- Not checked — no full text of the sourcecites [25] Hottelart C, Esper NE, Rose F, Achard J-M, Fournier A (2002) Fenofibrate increases creatinemia by increasing metabolic production of creatinine. Nephron 92:536–541 source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“*Values for estimated GFR in patients while on fenofibrate may be unreliable and may underestimate true GFR”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Triacylglycerols have been linked to nephropathy through mesangial cell uptake of very low-density lipoprotein (VLDL), inducing foam cell formation [32]”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [32] Anami Y, Kobori S, Sakai M et al (1997) Human beta-migrating very low density lipoprotein induces foam cell formation in human mesangial cells. Atherosclerosis 135:225–234 source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“ACE inhibitors increase creatinine through a true reduction in GFR secondary to reduced intraglomerular pressure, but are reno-protective because they decrease glomerular hyperfiltration and have anti-fibrogenic effects [26,27].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [26] Taal MW, Brenner BM (2000) Renoprotective benefits of RAS inhibition: from ACEI to angiotensin II antagonists. Kidney Int 57:1803–1817 source
- Not checked — no full text of the sourcecites [27] Bakris GL, Weir MR (2000) Angiotensin-converting enzyme inhibitor-associated elevations in serum creatinine. Is this a cause for concern? Arch Intern Med 160:685–693 source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“insulin resistance which is a risk factor for renal dysfunction [38].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [38] Agrawal V, Shah A, Rice C, Franklin BA, McCullough PA (2009) Impact of treating the metabolic syndrome on chronic kidney disease. Nat Rev Nephrol 5:520–528 source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“One strength of the FIELD study is that it is one of the largest type 2 diabetes randomised trials examining pre-specified renal outcomes.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The arguably small absolute fall in estimated GFR in the placebo group (8% over 5 years) may reflect good control of blood pressure, glycaemia and dyslipidaemia [39].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [39] Parving H-H, Lehnert H, Brochner-Mortensen J et al (2001) The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med 345:870–878 source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“We incorporated variables available in a usual-care context to ensure relevance to clinical practice.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The observed relationships between both hypertriacylglycerolaemia and dyslipidaemia and renal function in the FIELD study may also reflect insulin resistance which is a risk factor for renal dysfunction [38].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [38] Agrawal V, Shah A, Rice C, Franklin BA, McCullough PA (2009) Impact of treating the metabolic syndrome on chronic kidney disease. Nat Rev Nephrol 5:520–528 source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Serum cystatin C, an indicator of renal dysfunction in type 2 diabetes, also modestly increases in patients on fenofibrate without any change in inulin clearance [16] and reverts shortly after drug withdrawal (J.-C.Ansquer, Laboratoires Fournier SA, Dijon, France, personal communication), but has not yet been measured in FIELD.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [16] Ansquer J-C, Dalton RN, Causse E, Crimet D, Malicot KL, Foucher C (2008) Effect of fenofibrate on kidney function: a 6-week randomized crossover trial in healthy people. Am J Kidney Dis 51:904–913 source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Study sponsors had no role in data collection or analysis.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Acknowledgements
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“This compares favourably with 66 to 100 for ACE inhibitor use in MICRO-HOPE [41].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
What the sources say
- Not checked — no full text of the sourcecites [41] Gerstein HC, Yusuf S, Mann JFE et al (2000) Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE Substudy. Lancet 355:253–259 source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The study was designed by an independent Management Committee and coordinated by the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, NSW, Australia.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Acknowledgements
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The authors had full access to all study data.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Acknowledgements
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The size and consistency of the estimated GFR and albuminuria benefits support use of fenofibrate in type 2 diabetes to reduce renal morbidity, especially in patients with dyslipidaemia.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
plaindirectn = 9,795- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This appears to be independent of, and therefore additive to renin-angiotensin system blockade and glycaemic control.”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
hedgeddirectn = 9,795- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper relies on this without support.
The washout sub-study participants (n=661) are representative of the full FIELD cohort.
“Plasma creatinine was re-measured 8 weeks after treatment cessation at close-out (washout sub-study, n=661).”
The paper relies on this without support.
The revision of the albuminuria definition after unmasking did not bias the albuminuria results.
“This definition was revised to be sex-specific after the study was unmasked.”
The paper relies on this without support.
The FIELD population is representative of type 2 diabetes patients generally.
“Type 2 diabetic patients (n=9,795) aged 50 to 75 years were randomly assigned to fenofibrate (n=4,895) or placebo (n=4,900) for 5 years”
The paper relies on this without support.
Fenofibrate has a 20 h elimination half-life.
“Given that fenofibrate has a 20 h elimination half-life, this timepoint minimised any drug withdrawal rebound effect.”
The paper relies on this without support.
Fenofibrate is associated with changes in plasma creatinine.
“In analyses pre-specified 6 months prior to unmasking of the study, 661 patients were re-assessed 52±13 days after close-out to further evaluate the known fenofibrate-associated changes in plasma creatinine.”
The authors state this as an assumption.
The Helsinki sub-study's failure to demonstrate a reduction in albuminuria with fenofibrate is due to its small sample size.
“presumably due to the small sample size”
The paper relies on this without support.
Estimated GFR after washout accurately reflects true GFR, so that preservation of estimated GFR indicates structural renal preservation.
“The latter is most evident after treatment withdrawal.”
The paper relies on this without support.
Cimetidine is a well-recognised inhibitor of active tubular creatinine secretion.
“cimetidine (a well recognised inhibitor of this tubular secretion)”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“A reduction in eGFR was noted during study treatment, but this was reversed off therapy where eGFR levels were higher in the group that had been treated with long-term fenofi- brate (total eGFR loss 5.8 vs. 9.9 ml/min/1.73m 2 , p Ͻ 0.001) (24).”
From Effects of Fibrates in Kidney Disease (2012) · cites this paper as [24]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Overall, 4 trials had a Jadad score of 4 (24,25,32,35), 1 scored 3 (33), 2 scored 2 (29,31), and 1 scored 1 (30).”
From Effects of Fibrates in Kidney Disease (2012) · cites this paper as [24]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“A post-hoc analysis from the FIELD study reported that plasma creatinine levels in a cohort of 661 “substudy washout participants” 8 weeks after withdrawal from study treatment were significantly lower in participants who had received fenofibrate compared to placebo (p Ͻ 0.001)”
From Effects of Fibrates in Kidney Disease (2012) · cites this paper as [24]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“the FIELD investigators found that participants with higher baseline lipid levels had greater preservation in their eGFR with fenofibrate compared with those with more normal lipid levels.12”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“After a washout phase of 1 year in the FIELD study, participants who previously took fenofibrate had significantly lower serum creatinine levels compared with individuals assigned to placebo.”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
Experimental — accuracy not yet measured
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Finally, the FIELD study took place in Finland, New Zealand, and Australia, whereas the ACCORD study recruited participants from 77 North American centers.”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“there have been conflicting reports regarding the impact of fibrate therapy on kidney function (24,25).”
From Effects of Fibrates in Kidney Disease (2012) · cites this paper as [24]
The cited source says what the claim attributes to it.
In the citing paper
“suggesting longer-term renoprotective effects despite the initially elevated serum creatinine (24).”
From Effects of Fibrates in Kidney Disease (2012) · cites this paper as [24]
The cited source says what the claim attributes to it.
In the citing paper
“Indeed, the reduction in eGFR may not be paralleled by a reduction in directly measured GFR using inulin (24,37).”
From Effects of Fibrates in Kidney Disease (2012) · cites this paper as [24]
The cited source says what the claim attributes to it.
In the citing paper
“and the finding of beneficial effects of fenofibrate on albuminuria and eGFR in the diabetic population.12”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“Fenofibrate induces early and reversible reduction in estimated glomerular filtration rate (eGFR), but it may have protective effects on microvascular complications of diabetes.”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“Similar to our analysis, the FIELD study showed that compared with placebo, use of fenofibrate led to a rise in serum creatinine in the short-term, but in the long-term it reduced eGFR decline and lowered albuminuria without impacting the rate of ESRD onset.”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“In addition, we confirm prior reports that demonstrated the association of fenofibrate use with preservation of kidney function in patients with diabetes.12, 13”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“Our findings corroborate previous studies that show an initial rise in serum creatinine when starting fibrates that is reversible on cessation of the medication.12, 13, 21, 22”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
The cited source says what the claim attributes to it.
In the citing paper
“In addition, we confirm prior reports that demonstrated the association of fenofibrate use with preservation of kidney function in patients with diabetes.12, 13”
From Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes (2019) · cites this paper as [12]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated major: it would touch a result — a value a result rests on, reported and recomputed p-values on opposite sides of the significance level, two passages that conflict with no sign which is right, or a cited work retracted before this paper was published.
In the paper
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Discussion
“The chronic underlying decline in renal function among fenofibrate-treated patients was nevertheless still about twice that associated with normal ageing in the absence of diabetes (1.9 vs 0.9 ml min -1 1.73 m -2 per year) [17].”
§ Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study > Results
“This reflected a 5-year fall in estimated GFR of 1.9 ml min -1 1.73 m -2 in the fenofibrate group (from 89.2 to 87.3; p=0.07) vs 6.9 ml min -1 1.73 m -2 in the placebo group (from 87.5 to 80.6; p<0.001)”
Citations
Cites
A New Equation to Estimate Glomerular Filtration Rate
Levey, A. S., Stevens, L. A., Schmid, C. H., Zhang, Y. (., Castro, A. F., Feldman, H. I., Kusek, J. W., Eggers, P., Van Lente, F., Greene, T., et al. (2009) · Annals of Internal Medicine · doi:10.7326/0003-4819-150-9-200905050-00006 · Cited by 25,603
Levey, A. S., Bosch, J. P., Lewis, J. B., Greene, T., Rogers, N., Roth, D., & for the Modification of Diet in Renal Disease Study Group* (1999) · Annals of Internal Medicine · doi:10.7326/0003-4819-130-6-199903160-00002 · Cited by 15,079
Effect of a multifactorial intervention on mortality in type 2 diabetes
Gæde, P., Lund-Andersen, H., Parving, H.-H., & Pedersen, O. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0706245 · Cited by 3,465
(2005) · The Lancet · doi:10.1016/s0140-6736(05)67667-2 · Cited by 3,284
Self-citationThe effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes
Parving, H.-H., Lehnert, H., Bröchner-Mortensen, J., Gomis, R., Andersen, S., & Arner, P. (2001) · New England Journal of Medicine · doi:10.1056/nejmoa011489 · Cited by 2,873
Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus
(2010) · New England Journal of Medicine · doi:10.1056/nejmoa1001282 · Cited by 2,837
[Effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes].
Parving, H., Lehnert, H., Brøchner‐Mortensen, J., Gomis, R., Andersen, S., & Arner, P. (2001) · PubMed · Cited by 2,527
Klahr, S., Levey, A. S., Beck, G. J., Caggiula, A. W., Hunsicker, L., Kusek, J. W., & Striker, G. (1994) · New England Journal of Medicine · doi:10.1056/nejm199403313301301 · Cited by 2,328
Cited by
Sorted by citations
Mechanisms of Diabetic Complications
Forbes, J. M., & Cooper, M. E. (2013) · Physiological Reviews · doi:10.1152/physrev.00045.2011 · Cited by 2,890
“There is also evidence from the FIELD study, which has demonstrated the renoprotective effects in diabetic nephropathy (133, 161).”
BackgroundAuthors Task Force Members, Rydén, L., Grant, P. J., Anker, S. D., Berne, C., Cosentino, F., Danchin, N., Deaton, C., Escaned, J., Hammes, H., et al. (2013) · European Heart Journal · doi:10.1093/eurheartj/eht108 · Cited by 1,994
Kang, H. M., Ahn, S. H., Choi, P., Ko, Y.-A., Han, S. H., Chinga, F., Park, A. S. D., Tao, J., Sharma, K., Pullman, J., et al. (2015) · Nature Medicine · doi:10.1038/nm.3762 · Cited by 1,555
KDOQI clinical practice guideline for diabetes and CKD: 2012 update
(2012) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2012.07.005 · Cited by 1,320
Chapman, M. J., Ginsberg, H. N., Amarenco, P., Andreotti, F., Borén, J., Catapano, A. L., Descamps, O. S., Fisher, E., Kovanen, P. T., Kuivenhoven, J. A., et al. (2011) · European Heart Journal · doi:10.1093/eurheartj/ehr112 · Cited by 1,227
Metadata
- Authors
- on behalf of the FIELD Study investigators, Davis, T. M. E., Ting, R., Best, J. D., Donoghoe, M. W., Drury, P. L., Sullivan, D. R., Jenkins, A. J., O’Connell, R. L., Whiting, M. J., Glasziou, P. P., Simes, R. J., Kesäniemi, Y. A., Gebski, V. J., Scott, R. S., & Keech, A. C.
- Affiliations
- The University of Western Australia (AU)
- The University of Sydney (AU)
- Royal Prince Alfred Hospital (AU)
- The University of Melbourne (AU)
- Flinders Medical Centre (AU)
- Corresponding author
- Ting, R.
- Keech, A. C.
- ORCID
- Venue
- Diabetologia
- Published
- 2010-11-04
- Volume
- 54
- Issue
- 2
- Pages
- 280-290
- ISSN
- 0012-186X (ISSN-L)
- 1432-0428
- OpenAlex
- W2103393658
- Cited by
- 371
- References
- 52
- Citations by year
- 2026: 20 · 2025: 18 · 2024: 17 · 2023: 18 · 2022: 19 · 2021: 17 · 2020: 26 · 2019: 10 · 2018: 28 · 2017: 14 · 2016: 28 · 2015: 20 · 2014: 34 · 2013: 45 · 2012: 38
- FWCI
- 22.27
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Diabetologia (publishedVersion)
- PubMed (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- The Sydney eScholarship Repository (The University of Sydney) (submittedVersion)
- Funders
- Diabetes Australia
- Diabetesliitto
- Medical Research Council
- National Health and Medical Research Council
- Topics
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- fenofibrate, type 2 diabetes, renal function, estimated glomerular filtration rate, albuminuria, serum creatinine, hypertriglyceridemia, HDL cholesterol, statins, fibrates, drug-induced nephrotoxicity, fieldwork, lipid-lowering therapy, cardiovascular risk reduction, renal protection, triglyceride lowering
- MeSH terms
- Aged, Hypolipidemic Agents, Creatinine, Diabetes Mellitus, Type 2, Female, Glomerular Filtration Rate, Humans, Male, Middle Aged, Fenofibrate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-19, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-19 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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