The DOI matches its Crossref record; 66 of the 67 references it cites were found in a registry or an index; none of the 30 sources its claims cite is checked for support yet.
Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: The EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial
Open accessAbstract
Background Omega-3 fatty acids in free fatty acid form have enhanced bioavailability, and plasma levels are less influenced by food than for ethyl ester forms.Objective The aim was to evaluate the safety and lipid-altering efficacy in subjects with severe hypertriglyceridemia of an investigational pharmaceutical omega-3 free fatty acid (OM3-FFA) containing eicosapentaenoic acid and docosahexaenoic acid.Methods This was a multinational, double-blind, randomized, out-patient study. Men and women with triglycerides (TGs) ≥ 500 mg/dL, but <2000 mg/dL, took control (olive oil [OO] 4 g/d; n = 99), OM3-FFA 2 g/d (plus OO 2 g/d; n = 100), OM3-FFA 3 g/d (plus OO 1 g/d; n = 101), or OM3-FFA 4 g/d (n = 99) capsules for 12 weeks in combination with the National Cholesterol Education Program Therapeutic Lifestyle Changes diet.Results Fasting serum TGs changed from baseline by -25.9% (P < .01 vs OO), -25.5% (P < .01 vs OO), and -30.9% (P < .001 vs OO) with 2, 3, and 4 g/d OM3-FFA, respectively, compared with -4.3% with OO. Non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol-to-HDL-C ratio, very low-density lipoprotein cholesterol, remnant-like particle cholesterol, apolipoprotein CIII, lipoprotein-associated phospholipase A2, and arachidonic acid were significantly lowered (P < .05 at each OM3-FFA dosage vs OO); and plasma eicosapentaenoic acid and docosahexaenoic acid were significantly elevated (P < .001 at each OM3-FFA dosage vs OO). With OM3-FFA 2 and 4 g/d (but not 3 g/d), low-density lipoprotein cholesterol was significantly increased compared with OO (P < .05 vs OO). High-sensitivity C-reactive protein responses with OM3-FFA did not differ significantly from the OO response at any dosage. Fewer subjects reported any adverse event with OO vs OM3-FFA, but frequencies across dosage groups were similar. Discontinuation due to adverse event, primarily gastrointestinal, ranged from 5% to 7% across OM3-FFA dosage groups vs 0% for OO.Conclusions OM3-FFA achieved the primary end point for TG lowering and secondary end point of non-HDL-C lowering at 2, 3, and 4 g/d in persons with severe hypertriglyceridemia. This trial was registered at www.clinicaltrials.gov as NCT01242527.
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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 values are similar to the observed LSGM reductions of 30.9% and 44.3%, respectively.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“Non-HDL-C, total-Cto-HDL-C ratio, VLDL-C, RLP-C, and Apo CIII concentrations were also significantly reduced in each OM3-FFA treatment group compared with responses in the OO group.”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“plasma DHA and EPA concentrations increased significantly, and AA concentrations were reduced significantly in all OM3-FFA treatment groups compared with the OO group (all P , .001).”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“Apo AI concentration was increased in the OO group compared with responses to the 2 and 4 g/d OM3-FFA groups (P ,.01).”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“Total-C was reduced in all OM3-FFA treatment groups.Comparisons of the 2-and 4-g/d treatment groups vs OO showed statistical significance.”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“HDL-C increased slightly in all treatment groups, but no significant differences were found between the OO and OM3-FFA responses.”
- Also stated in: § Discussion · plain
“whereas HDL-C was not significantly changed vs OO with OM3-FFA at any dosage.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
- Also stated in: § Discussion · plain
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
“Non-HDL-C, total-Cto-HDL-C ratio, VLDL-C, RLP-C, and Apo CIII concentrations were also significantly reduced in each OM3-FFA treatment group compared with responses in the OO group.”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“plasma DHA and EPA concentrations increased significantly, and AA concentrations were reduced significantly in all OM3-FFA treatment groups compared with the OO group (all P , .001).”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“Apo B responses in each of the OM3-FFA groups were not significantly different than the OO response”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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 present trial, serum Apo CIII was lowered by 11%, 12%, and 14% with OM3-FFA dosages of 2, 3, and 4 g/d, respectively, compared with a 2% increase with OO.”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
- It may state two separate claims as one. 22
- The quote only partly states this claim. 2
- Probably not a substantial claim. 18
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
“Lp-PLA 2 , an enzyme that participates in inflammation and that has been shown to be an independent predictor of cardiovascular disease risk, 6,[52][53][54] was significantly lowered in all OM3-FFA treatment groups (changes from 211% to 217%) compared with the OO control group (22%).”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one. The quote only partly states this claim.
- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“LDL-C was significantly increased, compared with OO, in the 2-g/d and 4-g/d OM3-FFA groups (3% for OO vs 19% for both 2 g/d [P , .01] and 4 g/d [P , .001]).”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“Lp-PLA 2 declined significantly vs OO in each OM3-FFA treatment group (P , .01);changes in the OM3-FFA groups ranged from 211% to 217%.”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one. The quote only partly states this claim.
- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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 overall frequencies of AEs, inclusive of all types of events, leading to study discontinuation were similar across OM3-FFA dosages (5% to 7%) vs 0% for OO.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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
“OM3-FFA was safe and generally well tolerated.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“AA was reduced by 15.1%, 16.0%, and 23.2%, respectively, with the 2-, 3-, and 4-g/d dosages of OM3-FFA, compared with a 2.2% increase with OO.”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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 subjects were predominantly white (92%) and men (77%) with an average age of 51.5 years and body mass index of 31.2 kg/m 2 .”
Strength:plain· not yet calibratedn = 399Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. 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
“Fewer subjects reported any AE with OO (26%) than with OM3-FFA”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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
“Efficacy end points for each OM3-FFA arm were compared with OO with the use of analysis of covariance with baseline values as covariates and a stratification factor for users and nonusers of permitted lipid-altering drugs”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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
“Overall mean 6 SD compliance with study product was 97.3% 6 9.0% of expected doses, and no marked differences were observed in compliance between treatment groups.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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 targeted sample size of 332 subjects (83 per treatment arm) was expected to provide at least 80% power to detect a difference of at least 20% in TG percentage changes compared with OO, assuming a common standard deviation (SD) in percentage change of 35%, a 2-sided a 5 0.05 adjusted for 3 pairwise tests vs OO (Bonferroni method), and 10% attrition rate.”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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
“Only the results from the modified intent-to-treat sample are described herein because those from the per protocol sample did not differ materially.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“This sample size was also expected to provide 80% power to detect approximately 10% differences from OO in percentage changes of non-HDL-C and HDL-C, assuming a common SD of 17% in each variable”
Strength:hedged· not yet calibratedn = 332Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Apo B has also been shown to be more predictive of risk of coronary heart disease than LDL-C.39”
What the sources say
- Not checked yetcites [39] Sondermeijer, 2013, Non-HDL cholesterol vs. Apo B for risk of coronary heart disease in healthy individuals: the EPIC-Norfolk prospective population study, Eur J Clin Invest source
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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 was a double-blind, randomized, parallel, 4-arm study with 8 clinic visits conducted at 74 clinical sites”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“In severe hypertriglyceridemia the baseline LDL-C level is typically below average because a larger-than-normal fraction of total-C is carried in VLDL particles, in part because of inefficient TG hydrolysis and reduced rate of conversion of VLDL to LDL.”
What the sources say
- Not checked yetcites [31][32][33]
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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
“A stratified randomization scheme was used to ensure that treatment groups were balanced for the use of other allowed lipid-altering medications”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Apo CIII appears to play an important role in the pathogenesis of hypertriglyceridemia, particularly for inhibiting the action of lipoprotein lipase, thus slowing TG hydrolysis.47 Apo CIII also interferes with the interactions of TG-rich lipoproteins with hepatic Apo B/E receptors, slowing the removal of these particles from the circulation.”
What the sources say
- Not checked yetcites [47] Kawakami, 2009, Apolipoprotein CIII links dyslipidemia with atherosclerosis, J Atheroscler Thromb source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“Thus, the increase in LDL-C with OM3-FFA was not associated with an increase in the circulating concentration of atherogenic lipoprotein particles”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“Of the 399 persons randomly assigned to treatment, 364 completed the study.No significant differences were found among treatment groups in the number who discontinued (P 5 .146).”
Strength:plain· not yet calibratedn = 399Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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
“Normality assumptions were investigated with the Shapiro-Wilk test on the residuals.If the normality assumption was rejected (P , .01),data for that variable were ranked before the final analysis.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“are close to the line of best fit determined from an unweighted regression analysis of the relationship between mean or median baseline TGs and TG response to 4 g/d of pharmaceutical OM3 products”
What the sources say
- Not checked yetcites [10][11][12]
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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 study was conducted according to Good Clinical Practice Guidelines, the Declaration of Helsinki (2000), and the United States 21 Code of Federal Regulations.The study protocol and informed consent documents were approved by the local responsible institutional review boards/independent ethics committees in North America, Europe, and India before the study was initiated.A signed informed cons”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“OM3 fatty acid treatment lowers the TG level by both reducing the amount of hepatic TG secretion and by enhancing the rate of TG clearance from circulation.”
What the sources say
- Not checked yetcites 17,[40][41][42][43][44][45][46]
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
In the paper
“Lp-PLA 2 , an enzyme that participates in inflammation and that has been shown to be an independent predictor of cardiovascular disease risk, 6,[52][53][54]”
What the sources say
- Not checked yetcites 6,[52][53][54]
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“Investigators were blinded to the TG results, unless the values were .2000mg/dL.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“It is notable that the degree of TG reduction was smaller in the 3-g/d group than in the 2-or 4-g/d treatment groups.However, random variation cannot be excluded as an explanation for this unexpected pattern”
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Rests on an assumption: Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
- Rests on an assumption: Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
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
“a potential explanation for that effect could be a non-neutral effect of the mineral oil control on hs-CRP levels, because the significant differences in hs-CRP responses were attributable to increases in the control groups of these trials and not to reductions from baseline with EPA-EE.”
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In past studies with OM3-FFA, the incidence of gastrointestinal disturbance was high, which led to the development of a capsule with a coating to prevent the release of the free fatty acids into the stomach.”
What the sources say
- Not checked yetcites [3] Davidson, 2012, A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: The ECLIPSE (Epanova® compared to Lovaza® in a pharmacokinetic single-dose evaluation) study, J Clin Lipidol source
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
In the paper
“which is linked to increased platelet aggregation and production of prostaglandins and leukotrienes that enhance platelet activation and vasoconstriction.59”
What the sources say
- Not checked yetcites [59] DeCaterina, 1990, Vascular prostacyclins is increased in patients ingesting omega-3 polyunsaturated fatty acids before coronary artery bypass graft surgery, Circulation source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
In the paper
“Ethnicity has been described as a factor that may contribute to inconsistencies in results from studies of the effects of OM3 fatty acid consumption on cardiovascular disease outcomes.60”
What the sources say
- Not checked yetcites [60] Patel, 2010, Omega-3 polyunsaturated acids and cardiovascular disease: notable ethnic differences of unfulfilled promise?, J Thromb Haemost source
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Previous studies with OM3-EEs have also shown reduced Lp-PLA 2 ,”
What the sources say
- Not checked yetcites [34] Davidson, 2009, Effects of prescription omega-3-acid ethyl esters on lipoprotein particle concentrations, apolipoproteins AI and CIII, and lipoprotein-associated phospholipase A2 mass in statin-treated subjects with hypertriglyceridemia, J Clin Lipidol source
- Not checked yetcites [35] Maki, 2011, Effects of prescription omega-3-acid ethyl esters, coadministered with atorvastatin, on circulating levels of lipoprotein particles, apolipoprotein CIII and lipoprotein-associated phospholipase A2 mass in men and women with mixed dyslipidemia, J Clin Lipidol source
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Although recent investigations of EPA-EE have reported a placebo-corrected reduction on hs-CRP, 23,26,55”
What the sources say
- Not checked yetcites [23] Ballantyne, 2012, Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study), Am J Cardiol source
- Not checked yetcites [26] Bays, 2011, Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blInd, 12-week study with an open-label Extension [MARINE] trial), Am J Cardiol source
- Not checked yetcites [55] Bays, 2013, Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies, Am J Cardiovasc Drugs source
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
The paper relies on this without support.
Olive oil 4 g/d is an inert control that does not itself meaningfully alter triglycerides or non-HDL-C, so differences from olive oil can be attributed to OM3-FFA.
“control (olive oil [OO] 4 g/d)”
“compared with 24.3% with OO”
The paper relies on this without support.
Subjects adhered to the TLC diet and maintained weight during the trial, so observed lipid changes are not due to diet or weight changes.
“Subjects were instructed to follow the National Cholesterol Education Program Therapeutic Lifestyle Changes (TLC) diet”
“be willing to maintain their customary activity level, follow the TLC diet with weight maintenance”
The paper relies on this without support.
The olive oil control does not itself alter the lipid or inflammatory endpoints, so differences from olive oil can be attributed to omega-3 free fatty acids.
“hs-CRP was not reduced with OM3-FFA compared with OO.”
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
“Initial trials of omega-3 CAdemonstrateddose-dependentloweringofplasmatriglyceride levels up to 31%. 14,15”
From Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk (2020) · cites this paper as [14]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“To our best knowledge, this is the first dose–response meta‐analysis of the relationship between ω3 PUFA intake and non‐HDL‐C changes, an indicator of the cholesterol content of all atherogenic lipoproteins. 100 , 150 , 151”
From Association Between Omega-3 Fatty Acid Intake and Dyslipidemia: A Continuous Dose-Response Meta-Analysis of Randomized Controlled Trials (2023) · cites this paper as [151]
In the citing paper
“Treatment with OM3FAs decreases plasma apoCIII levels [7, 44].”
In the citing paper
“Although the HHS reported a significant reduction in CVD outcomes with gemfibrozil, neither the FIELD nor the ACCORD studies involving fenofibrate showed a reduction in total CVD outcomes.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [310]
In the citing paper
“The effect was most evident in people with elevated TG/low HDL-C levels.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [310]
In the citing paper
“The LEADER trial included male participants with lower-extremity arterial disease and failed to show that bezafibrate could lead to a clinically important reduction in CVD combined endpoints.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [310]
In the citing paper
“Although the HHS reported a significant reduction in CVD outcomes with gemfibrozil, neither the FIELD nor the ACCORD studies involving fenofibrate showed a reduction in total CVD outcomes.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [310]
In the citing paper
“Decreases in the rates of nonfatal MI were reported, although often as a result of post hoc analyses.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [310]
In the citing paper
“Only one study, ACCORD, has analysed the effect of a fibrate as an add-on treatment to a statin.”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [310]
In the citing paper
“| Omega-3 PUFA carboxylic | Adjunct to diet to reduce triglyceride levels in patients | 0.2 | 0.55 | 2 g once daily or | -30.9 | -7.5 þ5.8 þ19.4 | |”
From Cardiovascular Impact of Nutritional Supplementation With Omega-3 Fatty Acids (2021) · cites this paper as [94]
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.
Gastrointestinal withdrawals use the wrong denominator
MinorThe discussion says gastrointestinal events accounted for 3% of discontinuations. Earlier, the paper reports three gastrointestinal withdrawals in each active-treatment group-3% of subjects in each group-while total AE-related discontinuations were 5% to 7% of subjects per group. Gastrointestinal events therefore accounted for substantially more than 3% of discontinuations.
“(3% of discontinuations in the OM3-FFA groups were because of gastrointestinal AEs).”
“Discontinuation due to AEs, primarily gastrointestinal, ranged from 5% to 7% across dosage groups vs 0% for the OO group.Nine subjects withdrew because of gastrointestinal events among the OM3-FFA groups, and they were evenly distributed across the dosage groups: 3 (3%) in OM3-FFA 2 g/d, 3 (3%) in OM3-FFA 3 g/d, and 3 (3%) in OM3-FFA 4 g/d.”
Citations
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Metadata
- Authors
- Kastelein, J. J. P., Maki, K. C., Susekov, A., Ezhov, M., Nordestgaard, B. G., Machielse, B. N., Kling, D., & Davidson, M. H.
- Affiliations
- Amsterdam UMC Location University of Amsterdam (NL)
- BioFortis (United States) (US)
- Corresponding author
- Kastelein, John J.P.
- Venue
- Journal of Clinical Lipidology
- Publisher
- Elsevier BV
- Published
- 2014-01
- Volume
- 8
- Issue
- 1
- Pages
- 94-106
- ISSN
- 1876-4789 (ISSN-L)
- 1933-2874
- OpenAlex
- W2099767767
- Cited by
- 233
- References
- 67
- Citations by year
- 2026: 10 · 2025: 7 · 2024: 6 · 2023: 18 · 2022: 10 · 2021: 22 · 2020: 20 · 2019: 22 · 2018: 13 · 2017: 27 · 2016: 36 · 2015: 27 · 2014: 13
- FWCI
- 23.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of clinical lipidology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Keywords
- severe hypertriglyceridemia, eicosapentaenoic acid, docosahexaenoic acid, triglyceride lowering, olive oil, lipid-lowering efficacy, LDL cholesterol, non-HDL cholesterol, apolipoprotein C-III, lipoprotein-associated phospholipase A2, C-reactive protein
- MeSH terms
- Female, Humans, Male, Middle Aged, Triglycerides, Hypertriglyceridemia, Fatty Acids, Omega-3, Treatment Outcome, Endpoint Determination
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