The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index; 23 of the 38 sources its claims cite were checked for support.
Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients
Open accessAbstract
Importance: The effects of bempedoic acid on cardiovascular outcomes in statin-intolerant patients without a prior cardiovascular event (primary prevention) have not been fully described. Objective: To determine the effects of bempedoic acid on cardiovascular outcomes in primary prevention patients. Design, Setting, and Participants: This masked, randomized clinical trial enrolled 13 970 statin-intolerant patients (enrollment December 2016 to August 2019 at 1250 centers in 32 countries), including 4206 primary prevention patients. Interventions: Participants were randomized to oral bempedoic acid, 180 mg daily (n = 2100), or matching placebo (n = 2106). Main Outcome Measures: The primary efficacy measure was the time from randomization to the first occurrence of any component of a composite of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization. Results: Mean participant age was 68 years, 59% were female, and 66% had diabetes. From a mean baseline of 142.2 mg/dL, compared with placebo, bempedoic acid reduced low-density lipoprotein cholesterol levels by 30.2 mg/dL (21.3%) and high-sensitivity C-reactive protein levels by 0.56 mg/L (21.5%), from a median baseline of 2.4 mg/L. Follow-up for a median of 39.9 months was associated with a significant risk reduction for the primary end point (111 events [5.3%] vs 161 events [7.6%]; adjusted hazard ratio [HR], 0.70 [95% CI, 0.55-0.89]; P = .002) and key secondary end points, including the composite of cardiovascular death, MI, or stroke (83 events [4.0%] vs 134 events [6.4%]; HR, 0.64 [95% CI, 0.48-0.84]; P < .001); MI (29 events [1.4%] vs 47 events [2.2%]; HR, 0.61 [95% CI, 0.39-0.98]); cardiovascular death (37 events [1.8%] vs 65 events [3.1%]; HR, 0.61 [95% CI, 0.41-0.92]); and all-cause mortality (75 events [3.6%] vs 109 events [5.2%]; HR, 0.73 [95% CI, 0.54-0.98]). There was no significant effect on stroke or coronary revascularization. Adverse effects with bempedoic acid included a higher incidence of gout (2.6% vs 2.0%), cholelithiasis (2.5% vs 1.1%), and increases in serum creatinine, uric acid, and hepatic enzyme levels. Conclusions: In a subgroup of high-risk primary prevention patients, bempedoic acid treatment was associated with reduced major cardiovascular events. Trial Registration: ClinicalTrials.gov Identifier: NCT02993406
Overview
AI snapshot
Written from the paper’s full text.
TL;DR
In a prespecified primary prevention subgroup of statin-intolerant patients from CLEAR Outcomes, bempedoic acid reduced the primary 4-component MACE composite compared with placebo over a median 39.9 months. Benefits were also seen for 3-component MACE, MI, cardiovascular death, and all-cause mortality, with higher rates of gout, cholelithiasis, hyperuricemia, hepatic enzyme elevation, and kidney adverse events.
Key findings
- The primary 4-component MACE end point occurred in 111 patients (5.3%) with bempedoic acid vs 161 (7.6%) with placebo (adjusted HR, 0.70 [95% CI, 0.55-0.89]; P = .002); NNT was 43.
- Key secondary outcomes were reduced: 3-component MACE 83 (4.0%) vs 134 (6.4%) (HR, 0.64 [95% CI, 0.48-0.84]; P < .001); MI 29 (1.4%) vs 47 (2.2%) (HR, 0.61 [95% CI, 0.39-0.98]); cardiovascular death 37 (1.8%) vs 65 (3.1%) (HR, 0.61 [95% CI, 0.41-0.92]); all-cause mortality 75 (3.6%) vs 109 (5.2%) (HR, 0.73 [95% CI, 0.54-0.98]).
- Stroke and coronary revascularization were not significantly reduced: stroke 27 (1.3%) vs 37 (1.8%) (HR, 0.76 [95% CI, 0.46-1.26]); coronary revascularization 50 (2.4%) vs 68 (3.2%) (HR, 0.71 [95% CI, 0.49-1.03]).
- Bempedoic acid reduced LDL-C by 30.2 mg/dL (21.3%) from a mean baseline of 142.2 mg/dL and hsCRP by 0.56 mg/L (21.5%) from a median baseline of 2.4 mg/L; adverse events included hyperuricemia (12.1% vs 6.3%), gout (2.6% vs 2.0%), cholelithiasis (2.5% vs 1.1%), elevated hepatic enzymes (4.5% vs 2.6%), and kidney impairment (10.3% vs 8.1%).
Methods
- Prespecified subgroup analysis of the masked, randomized CLEAR Outcomes trial, conducted at 1250 centers in 32 countries; enrollment was December 2016 to August 2019, and the analysis included 4206 primary prevention patients among 13,970 statin-intolerant patients.
- Participants were randomized 1:1 to oral bempedoic acid 180 mg daily (n = 2100) or matching placebo (n = 2106); eligible primary prevention patients were aged 18 to 85 years with LDL-C ≥100 mg/dL and high-risk features, and had statin intolerance.
- Efficacy was analyzed by Cox proportional hazards models adjusted for baseline characteristics, with log-rank P values, in the intent-to-treat population; outcomes were not adjusted for multiplicity, and safety analyses used all randomized patients who received at least 1 dose.
Limitations
- Stated: this is a secondary analysis of a subpopulation in a larger randomized trial, so false-positive findings from multiple subgroup testing or chance are possible; the authors note consistency across end points strengthens reliability.
- Stated: the sample size and event numbers were smaller than the full trial, producing wider confidence intervals; patients had high baseline LDL-C due to statin intolerance, so effects in populations with lower pretreatment LDL-C were not studied.
- Stated: patients were selected by specific high-risk criteria, so outcomes with other risk criteria remain uncertain; the text also makes evident that efficacy outcomes were not adjusted for multiplicity.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
62 Own result · 26 Own method · 9 Partly supported · 6 Own interpretation · 5 No basis given · 3 Supported · 3 Couldn’t confirm · 3 No full text of the sources · 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
“More than half of eligible patients do not currently receive lipid-lowering therapies.9”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > S
What the sources say
- Partly supportedcites [9] Gamboa, 2014, Statin underuse and low prevalence of LDL-C control among US adults at high risk of coronary heart disease., Am J Med Sci sourceExperimental — accuracy not yet measured
The Discussion reports that fewer than half of the U.S. adults studied who were at high risk for coronary heart disease were taking statins. The study measured statin use, not use of all lipid-lowering therapies, and its finding is limited to that high-risk population rather than all eligible patients. (LLM, conf=0.85)
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
Every source the paper cites for this claim was checked and supports it.
In the paper
“The CLEAR Outcomes (Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen) trial reported cardiovascular outcomes in a mixed population of primary and secondary prevention patients unable or unwilling to take guideline-recommended doses of statins.11”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > S
What the sources say
- Supportedcites [11] Nissen, 2023, Bempedoic acid and cardiovascular outcomes in statin-intolerant patients., N Engl J Med source
The Abstract states that CLEAR Outcomes studied cardiovascular events in a mixed primary- and secondary-prevention population unable or unwilling to take guideline-recommended statin doses. The Trial Population and Trial End Points sections confirm the two patient groups and the cardiovascular outcomes assessed. (LLM, conf=0.95)
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.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Recent data are limited on the effects of statins or other adjunctive treatments in patients without a history of a cardiovascular event, leading some authors to question whether the benefits of cholesterol lowering exceed the harms in these patients.[4][5][6][7]”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > S
What the sources say
- Not checked — no full text of the sourcecites [4] Redberg, 2017, Statins for primary prevention: the debate is intense, but the data are weak., JAMA Intern Med source
- Not checked — no full text of the sourcecites [5] Byrne, 2019, Statins for primary prevention of cardiovascular disease., BMJ source
- Not checked — no full text of the sourcecites [6] Yebyo, 2019, Finding the balance between benefits and harms when using statins for primary prevention of cardiovascular disease: a modeling study., Ann Intern Med source
- Partly supportedcites [7] Byrne, 2022, Evaluating the association between low-density lipoprotein cholesterol reduction and relative and absolute effects of statin treatment: a systematic review and meta-analysis., JAMA Intern Med sourceExperimental — accuracy not yet measured
The Abstract and Conclusions say the absolute benefits of statins are modest and that heterogeneity limits certainty. The Results also report effects for primary-prevention patients, so the paper does not establish that data on statin effects in this group are generally limited. It does not assess other adjunctive treatments. (LLM, conf=0.78)
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.
- Rests on an assumption: Most contemporary cardiovascular outcome trials of lipid-lowering therapies have enrolled only participants with a prior cardiovascular event.
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
“However, the current recommendations are predominantly derived from clinical trials conducted several decades ago during the initial development of statins to reduce low-density lipoprotein cholesterol (LDL-C) levels.2,3”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > S
What the sources say
- Supportedcites [2] Shepherd, 1995, Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia., N Engl J Med source
The cited 1995 paper serves as an example of the older primary-prevention statin trials described in the sentence. Its Abstract reports a pravastatin trial in men without a history of myocardial infarction and states that the drug reduced LDL cholesterol. The paper does not itself assess how much current recommendations depend on such trials. (LLM, conf=0.86)
- Not checked — no full text of the sourcecites [3] Downs, 1998, Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS., JAMA 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.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Reduction in LDL-C has been strongly associated with improved cardiovascular outcomes, and 3 recent trials have demonstrated favorable effects with anti-inflammatory therapies.[21][22][23][24]”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Supportedcites [21] Mihaylova, 2012, The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials., Lancet source
The Results report that statin-associated LDL cholesterol reduction was accompanied by a 21% lower risk of major vascular events per 1·0 mmol/L reduction across 27 trials. This supports the LDL-C and cardiovascular-outcomes portion of the sentence; the separate claim about anti-inflammatory therapies is not attributed to this source. (LLM, conf=0.94)
- Supportedcites [22] Ridker, 2017, Antiinflammatory therapy with canakinumab for atherosclerotic disease., N Engl J Med source
The introduction (p. 1120) says that beneficial outcomes after statin therapy relate in part to reduced cholesterol levels. The discussion also describes cardiovascular benefit from PCSK9-targeting therapies in its comparison with canakinumab. Together, these passages support the broad association claimed, though this trial tested anti-inflammatory treatment rather than LDL-C reduction. (LLM, conf=0.84)
- Could not verifycites [23] Tardif, 2019, Efficacy and safety of low-dose colchicine after myocardial infarction., N Engl J Med sourceExperimental — accuracy not yet measured
The Methods (p. 1) and Discussion (p. 7) concern colchicine after myocardial infarction and cardiovascular events, not the effect of lowering LDL-C. A search for LDL cholesterol reduction and lipid lowering found no passage in our copy supporting the quoted claim; the paper does support the citing sentence’s separate point about anti-inflammatory therapy. (LLM, conf=0.76)
boostedcorrelational- 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
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“In a registry of nearly 50 000 US patients with LDL-C levels greater than 190 mg/dL but without cardiovascular disease, only 58.5% were taking a statin.15”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Partly supportedcites [15] Virani, 2018, Variation in lipid-lowering therapy use in patients with low-density lipoprotein cholesterol =190 mg/dL: insights from the National Cardiovascular Data Registry–Practice Innovation and Clinical Excellence Registry., Circ Cardiovasc Qual Outcomes sourceExperimental — accuracy not yet measured
The Results (page unavailable) report 49,447 patients with LDL-C ≥190 mg/dL and a 58.5% statin-therapy rate for the full cohort. The Abstract’s Methods and Results give a different rate, 50.8%, for patients without concomitant ASCVD. The Discussion also clarifies that the registry recorded prescriptions, not whether patients took the medication. (LLM, conf=0.91)
plainn = 50,000- 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
“MI (29 events [1.4%] vs 47 events [2.2%]; HR, 0.61 [95% CI, 0.39-0.98])”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > 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
“cardiovascular death (37 events [1.8%] vs 65 events [3.1%]; HR, 0.61 [95% CI, 0.41-0.92])”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > 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
“There was no significant effect on stroke or coronary revascularization.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Abstract
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.
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
“Adverse effects with bempedoic acid included a higher incidence of gout (2.6% vs 2.0%), cholelithiasis (2.5% vs 1.1%), and increases in serum creatinine, uric acid, and hepatic enzyme levels.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Abstract
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.
- Probably not a substantial claim. 31
- It may state two separate claims as one. 21
The cited sources that could be checked couldn’t confirm or dispute this claim.
In the paper
“The effects of bempedoic acid on cardiovascular outcomes in statin-intolerant patients without a prior cardiovascular event (primary prevention) have not been fully described.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Abstract
What the sources say
- Not checked — no full text of the sourcecites [4] Redberg, 2017, Statins for primary prevention: the debate is intense, but the data are weak., JAMA Intern Med source
- Not checked — no full text of the sourcecites [5] Byrne, 2019, Statins for primary prevention of cardiovascular disease., BMJ source
- Not checked — no full text of the sourcecites [6] Yebyo, 2019, Finding the balance between benefits and harms when using statins for primary prevention of cardiovascular disease: a modeling study., Ann Intern Med source
- Could not verifycites [7] Byrne, 2022, Evaluating the association between low-density lipoprotein cholesterol reduction and relative and absolute effects of statin treatment: a systematic review and meta-analysis., JAMA Intern Med sourceExperimental — accuracy not yet measured
The Abstract and Methods describe a review of statin trials, including primary-prevention trials, but do not address bempedoic acid or statin-intolerant patients. Searches for “bempedoic acid” and the claimed primary-prevention population found no passage assessing whether bempedoic acid’s cardiovascular effects had been fully described. (LLM, conf=0.75)
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.
- Rests on an assumption: Most contemporary cardiovascular outcome trials of lipid-lowering therapies have enrolled only participants with a prior cardiovascular event.
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Currently, lipid-lowering therapies are underutilized in high-risk primary prevention patients, particularly women and patients from racial and ethnic minority populations.[8][9][10]”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > S
What the sources say
- Partly supportedcites [8] Navar, 2017, Lipid management in contemporary community practice: results from the Provider Assessment of Lipid Management (PALM) registry., Am Heart J sourceExperimental — accuracy not yet measured
The Results (page unavailable) report that only 36.0% of eligible primary-prevention patients received guideline-recommended statin intensity, and the Discussion (page unavailable) says women were less likely than men to receive it. The passages do not establish that patients from racial or ethnic minority populations were particularly undertreated; they also concern statins rather than lipid-lowering therapies generally. (LLM, conf=0.86)
- Partly supportedcites [9] Gamboa, 2014, Statin underuse and low prevalence of LDL-C control among US adults at high risk of coronary heart disease., Am J Med Sci sourceExperimental — accuracy not yet measured
The Discussion reports that only one in five participants with FRS >20% and no history of CHD, stroke, AAA, or diabetes was taking a statin, supporting underuse in high-risk primary prevention. It also identifies being a woman or Black as associated with not taking statins among high-risk participants overall, but does not establish those associations specifically in the primary-prevention subgroup or for racial and ethnic minority populations broadly. No page numbers are available in our copy. (LLM, conf=0.86)
- Not checked — no full text of the sourcecites [10] Jacobs, 2023, Prevalence of statin use for primary prevention of atherosclerotic cardiovascular disease by race, ethnicity, and 10-year disease risk in the US: National Health and Nutrition Examination Surveys, 2013 to March 2020., JAMA Cardiol source
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.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The Heart Outcomes Prevention Evaluation 3 (HOPE-3), published in 2016, showed that low-dose statin therapy reduced the composite cardiovascular outcome by 24% but had no significant effect on mortality.19”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Partly supportedcites [19] Yusuf, 2016, Cholesterol lowering in intermediate-risk persons without cardiovascular disease., N Engl J Med sourceExperimental — accuracy not yet measured
The Methods (p. 1) identify HOPE-3’s 10-mg-per-day rosuvastatin comparison, and the Results (p. 1) report a hazard ratio of 0.76 for the first composite cardiovascular outcome—a 24% relative reduction. The passages available in our copy do not report a separate mortality result, so they do not support the claim that mortality was unaffected; searches for mortality and all-cause death found no such result. (LLM, conf=0.87)
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.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“This primary prevention cohort was a prespecified subgroup that represented 30% of the total enrolled within a larger trial that included a mixed population of primary and secondary prevention patients.11”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Supportedcites [11] Nissen, 2023, Bempedoic acid and cardiovascular outcomes in statin-intolerant patients., N Engl J Med source
Table 1 in the Results lists primary-prevention patients as 30.0% and 30.2% of the two trial groups, alongside secondary-prevention patients. The Discussion describes the mixed trial population and refers to the primary-prevention subgroup before discussing the “other prespecified subgroup analyses,” supporting that this subgroup was prespecified. (LLM, conf=0.91)
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.
- 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
“These findings emphasize the potential value of lipidmodulating therapy in patients who have had no prior cardiovascular event but who have a high risk for a first event, a population that is currently undertreated.[8][9][10][15][16][17][18]”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Supportedcites [8] Navar, 2017, Lipid management in contemporary community practice: results from the Provider Assessment of Lipid Management (PALM) registry., Am Heart J source
The Methods define a primary-prevention group that includes adults without prior cardiovascular disease who have elevated 10-year ASCVD risk and are recommended for statins. The Results report that only 63.4% of eligible primary-prevention patients were taking a statin and 36.0% received the recommended intensity; the paper also describes the cardiovascular risk-reduction rationale for statin therapy in high-risk adults. Page numbers are unavailable in our copy. (LLM, conf=0.92)
- Supportedcites [9] Gamboa, 2014, Statin underuse and low prevalence of LDL-C control among US adults at high risk of coronary heart disease., Am J Med Sci source
The Introduction says guidelines recommended intensive LDL-C-lowering treatment for people without CHD or risk equivalents whose Framingham risk score exceeded 20%. The Discussion reports that only one in five people in this group was taking a statin, supporting the claim that this high-risk, event-free population was undertreated. (LLM, conf=0.91)
- Not checked — no full text of the sourcecites [10] Jacobs, 2023, Prevalence of statin use for primary prevention of atherosclerotic cardiovascular disease by race, ethnicity, and 10-year disease risk in the US: National Health and Nutrition Examination Surveys, 2013 to March 2020., JAMA Cardiol source
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.
Probably not a substantial claim.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The 2 classic trials of primary prevention patients published in the 1990s showed a reduction in morbidity but not mortality.2,3”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Partly supportedcites [2] Shepherd, 1995, Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia., N Engl J Med sourceExperimental — accuracy not yet measured
The Results report significantly fewer nonfatal myocardial infarctions with pravastatin. Death from any cause was lower but did not meet the conventional threshold for statistical significance (P=0.051). However, the End Points section reports a significant reduction in cardiovascular deaths (P=0.033), so the unqualified statement that mortality was not reduced overstates this trial’s findings. This verdict concerns only the cited pravastatin trial, not the other trial mentioned in the sentence. (LLM, conf=0.88)
- Not checked — no full text of the sourcecites [3] Downs, 1998, Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS., JAMA 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.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Reduction in LDL-C has been strongly associated with improved cardiovascular outcomes, and 3 recent trials have demonstrated favorable effects with anti-inflammatory therapies.[21][22][23][24]”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Could not verifycites [21] Mihaylova, 2012, The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials., Lancet sourceExperimental — accuracy not yet measured
The Methods (Trials) describe studies of LDL-cholesterol-lowering interventions, and the Discussion reports improved vascular outcomes with statin therapy. Neither passage addresses the quoted claim that three trials found favorable effects of anti-inflammatory therapies; searches for anti-inflammatory therapies and inflammation found no such report in our copy. (LLM, conf=0.76)
- Supportedcites [22] Ridker, 2017, Antiinflammatory therapy with canakinumab for atherosclerotic disease., N Engl J Med source
The Conclusions report that the anti-inflammatory canakinumab trial significantly reduced recurrent cardiovascular events versus placebo. This paper supports one of the favorable anti-inflammatory trial results cited; it need not document all three trials. (LLM, conf=0.92)
- Supportedcites [23] Tardif, 2019, Efficacy and safety of low-dose colchicine after myocardial infarction., N Engl J Med source
The Discussion (p. 8) concludes that the COLCOT trial found significantly fewer ischemic cardiovascular events with low-dose colchicine than with placebo after a recent myocardial infarction. This supports the cited paper as one of the trials showing a favorable effect of anti-inflammatory therapy; the sentence's multiple citations collectively address the three-trial count. (LLM, conf=0.92)
boosteddirect- 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.
- Could not verify
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Another study of US patients eligible for treatment based on current guidelines reported that 53% of patients treated in cardiology practices were not taking a statin.16”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Partly supportedcites [16] Pokharel, 2017, Adoption of the 2013 American College of Cardiology/American Heart Association cholesterol management guideline in cardiology practices nationwide., JAMA Cardiol sourceExperimental — accuracy not yet measured
The Results report statin-treatment gaps among guideline-eligible patients in US cardiology practices. But the figure closest to 53% is the complement of the 46.9% receiving moderate- or high-intensity statins in one risk subgroup—not the percentage of all eligible patients taking no statin. The Discussion separately identifies eligible patients who received no statin, without giving the claimed 53% figure. (LLM, conf=0.90)
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.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“In a registry that studied reasons why eligible patients were not taking a statin, 59% reported never being offered treatment, 10% declined a statin, and 31% discontinued therapy.18”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Supportedcites [18] Bradley, 2019, Patient-reported reasons for declining or discontinuing statin therapy: insights from the PALM registry., J Am Heart Assoc source
The Results section reports that, among 1,511 PALM registry adults recommended for statins but not taking them, 59.2% said they had never been offered one, 10.1% had declined, and 30.7% had discontinued therapy. The citing sentence rounds these figures accurately. (LLM, conf=0.95)
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.
- Supported
The cited sources that could be checked couldn’t confirm or dispute this claim.
In the paper
“The CTTC analysis showed a 22% reduction in major coronary events for each 38.7-mg/dL (1-mmol/L) decrease in LDL-C level and a 15% reduction in vascular death.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Could not verifycites [24] Nidorf, 2020, Colchicine in patients with chronic coronary disease., N Engl J Med sourceExperimental — accuracy not yet measured
The References name a Cholesterol Treatment Trialists’ meta-analysis, but this paper does not report the claimed 22% and 15% reductions. Its Discussion and limitations (p. 1846) concern colchicine and state that lipid levels were not collected; searches for the LDL-C decrease and both percentages found no supporting passage. (LLM, conf=0.75)
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. It may state two separate claims as one.
- Could not verify
The cited sources that could be checked couldn’t confirm or dispute this claim.
In the paper
“The CTTC analysis reported that the benefits of lowering LDL-C level were consistent across a wide spectrum of baseline risk varying from less than 5% to 30% or greater.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Could not verifycites [24] Nidorf, 2020, Colchicine in patients with chronic coronary disease., N Engl J Med sourceExperimental — accuracy not yet measured
The References list a Cholesterol Treatment Trialists’ meta-analysis, and the Discussion (p. 1846) mentions lipid-lowering therapies, but neither reports benefits across baseline-risk categories. The paper says it did not collect lipid levels and could not report outcomes by risk-factor control (p. 1846). Searches for the claimed <5% to ≥30% risk range found no supporting passage. (LLM, conf=0.76)
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.
- Could not verify
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
“Stroke and coronary revascularization were not significantly reduced.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > 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
“There were no betweengroup differences in serious adverse events or adverse events leading to drug discontinuation.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Adverse Effects
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
“Within the full analysis set, 4206 patients (30%) met primary prevention criteria, 2100 randomized to the bempedoic acid treatment group and 2106 to the placebo group.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Population
plainn = 4,206- 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.
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
“With administration of additional lipid-modifying therapies to 12.4% of patients in the placebo group and 6.7% in the bempedoic acid group (eTable 1 in Supplement 2), the time-averaged difference in LDL-C level in the primary prevention subgroup over the course of the trial was 23.2 mg/dL (eFigure 2 in Supplement 2).”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Effects on LDL-C and hsCRP Levels
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
“Rates of new-onset diabetes and the change in hemoglobin A 1c levels in patients with diabetes at baseline were similar in both randomized groups.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Adverse Effects
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
“From a median baseline value of 2.4 mg/L, after 12 months of treatment, using Hodges-Lehman estimate of location shift, bempedoic acid reduced hsCRP level by 0.34 mg/L (95% CI, -0.42 to -0.29) compared with a reduction of 0.01 mg/L (95% CI, -0.04 to 0.09) for placebo, a difference of 0.56 mg/L (21.5%).”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Effects on LDL-C and hsCRP Levels
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.
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
“In the current study, women comprised nearly 60% of the population.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > 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.
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
“Treatment was also associated with significant reductions in MI, cardiovascular death, and all-cause mortality.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Conclusion
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.
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 masked, randomized clinical trial enrolled 13 970 statin-intolerant patients (enrollment December 2016 to August 2019 at 1250 centers in 32 countries), including 4206 primary prevention patients.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Abstract
plainn = 13,970- 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 protocol was approved by ethics committees at participating sites, and all patients provided written informed consent before enrollment”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Trial Organization and Oversight
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
“Eligible patients entered a 4-week run-in period during which they were treated with single-masked placebo.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Procedures
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
“The protocol was approved by ethics committees at participating sites, and all patients provided written informed consent before enrollment”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Trial Organization and Oversight
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
“An independent data monitoring committee monitored the trial.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Trial Organization and Oversight
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
“Efficacy analyses included all randomized patients based on the intent-totreat principle.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Statistical Analysis
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
“Between December 2016 and August 2019, 22 084 patients were screened and 14 016 were randomized, with 13 970 included in the full analysis after exclusion of 46 participants from a site determined to have created fraudulent patients.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Population
plainn = 13,970- 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
“Although the current study was not designed to assess factors mediating the results, both LDL-C and hsCRP levels were significantly reduced.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > 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.
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
“End points were adjudicated by C5Research clinical end points committee personnel masked to treatment assignments.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study End Points
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
“Both the patient and site investigator were required to provide written confirmation that the patient was statin intolerant and aware of the benefits of statins to reduce the risk of cardiovascular events, including death, and acknowledge that many patients unable to tolerate a statin can tolerate a different statin or dose.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Trial Population
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
“Outcomes were not adjusted for multiplicity.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > 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.
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 current findings support the guideline recommendation that primary prevention patients with diabetes should be treated with statins to lower cholesterol levels.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
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: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no reason why it holds.
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
“Complete assessment for the primary end point was available for 94.7% and vital status for 99.5% of these patients.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Population
plainn = 4,206- 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
“Efficacy end points at sites in Ukraine were censored after the start of the conflict on February 24, 2022.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Population
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
“If patients were intolerant to placebo treatment or if adherence was less than 80% by tablet count, they were not eligible for randomization.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Procedures
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
“Patients who successfully completed the run-in period were randomly assigned in a 1:1 ratio to receive a 180-mg oral dose of bempedoic acid or matching placebo, administered daily.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Procedures
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
“The P value was not statistically significant; therefore, the assumption of proportional hazards was determined to be met.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Statistical Analysis
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
“High-risk primary prevention patients were followed up for a median of 39.9 months.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Population
plainn = 4,206- 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
“During the trial, LDL-C and high-sensitivity C-reactive protein (hsCRP) results were masked.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Study Procedures
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 Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) study published 15 years ago showed a 44% reduction in the primary composite outcome and a 20% reduction in all-cause mortality with statin therapy in primary prevention patients with an hsCRP level greater than 2.0 mg/L.20”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
What the sources say
- Not checked — no full text of the sourcecites [20] Ridker, 2008, Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein., N Engl J Med source
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.
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
“Adverse event summaries were based on the safety population that included all patients who underwent randomization and received at least 1 dose of study drug.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > 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.
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 statistical analysis plan prespecified subgroup analyses for 4-component MACE and 3-component MACE.Therefore, P values are provided only for these end points.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > 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
“Second, because the sample size represented a fraction of the total enrolled population, the number of events was smaller, resulting in wider confidence intervals.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Limitations
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.
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
“First, this is a secondary analysis of a subpopulation in a larger randomized trial.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Limitations
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.
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
“Whether outcomes would be similar in patients identified using other criteria for an increased risk remains uncertain.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Limitations
hedged- 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 criteria used to select patients for a high level of risk of a first cardiac event are valid for identifying such risk.
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
“Such analyses can result in false-positive findings due to the testing of multiple subgroups and may represent the play of chance.”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Limitations
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. It may state two separate claims as one.
The paper relies on this without support.
Most contemporary cardiovascular outcome trials of lipid-lowering therapies have enrolled only participants with a prior cardiovascular event.
“Most contemporary cardiovascular outcome trials of lipid-lowering therapies have enrolled only participants with a prior cardiovascular event.”
The paper relies on this without support.
Censoring efficacy end points at sites in Ukraine after the start of the conflict on February 24, 2022, does not bias the estimated treatment effects.
“Efficacy end points at sites in Ukraine were censored after the start of the conflict on February 24, 2022.”
The paper relies on this without support.
Excluding 46 participants from a site determined to have created fraudulent patients does not bias the efficacy results.
“with 13 970 included in the full analysis after exclusion of 46 participants from a site determined to have created fraudulent patients.”
The paper relies on this without support.
Current guidelines do not specifically address the use of nonstatin treatments in high-risk primary prevention patients.
“Current guidelines do not specifically address the use of nonstatin treatments in high-risk primary prevention patients.”
The paper relies on this without support.
The CTTC analysis's predicted relationship between LDL-C lowering and cardiovascular event reduction applies to bempedoic acid and the current trial population.
“In the current study, a timeaveraged reduction of 23.2 mg/dL (0.60 mmol/L) was associated with larger reductions in cardiovascular morbidity and mortality than predicted by the CTTC analysis.”
The paper relies on this without support.
The criteria used to select patients for a high level of risk of a first cardiac event are valid for identifying such risk.
“Fourth, the trial selected patients using specific criteria for a high level of risk of a first cardiac event.”
The paper relies on this without support.
Patients' self-reported inability to tolerate statins accurately identifies statin intolerance.
“Third, the inclusion of patients who reported inability to tolerate statins resulted in a high mean baseline LDL-C level.”
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
“For individuals requiring primary prevention, the use of bempedoic acid resulted in a 30% reduction in primary composite outcome compared with placebo (137).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [137]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“For individuals requiring primary prevention, the use of bempedoic acid resulted in a 30% reduction in primary composite outcome compared with placebo (143).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [143]
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 minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > Discussion
“The Cholesterol Treatment Trialists Collaboration (CTTC) meta-analysis reported on outcomes for statin treatment in patients without vascular disease.24”
§ Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients > References
“24. Nidorf SM, Fiolet ATL, Mosterd A, et al; LoDoCo2 Trial Investigators. Colchicine in patients with chronic coronary disease.”
Citations
Cites
Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease
Ridker, P. M., Everett, B. M., Thuren, T., MacFadyen, J. G., Chang, W. H., Ballantyne, C., Fonseca, F., Nicolau, J., Koenig, W., Anker, S. D., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1707914 · Cited by 9,482
Self-citationPrevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia
Shepherd, J., Cobbe, S. M., Ford, I., Isles, C. G., Lorimer, A. R., Macfarlane, P. W., McKillop, J. H., & Packard, C. J. (1995) · New England Journal of Medicine · doi:10.1056/nejm199511163332001 · Cited by 7,449
Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein
Ridker, P. M., Danielson, E., Fonseca, F. A. H., Genest, J., Gotto, A. M., Kastelein, J. J. P., Koenig, W., Libby, P., Lorenzatti, A. J., MacFadyen, J. G., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0807646 · Cited by 6,674
Self-citationEstimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project
Conroy, R. (2003) · European Heart Journal · doi:10.1016/s0195-668x(03)00114-3 · Cited by 5,290
Downs, J. R., Clearfield, M., Weis, S., Whitney, E., Shapiro, D. R., Beere, P. A., Langendorfer, A., Stein, E. A., Kruyer, W., Gotto, Jr., et al. (1998) · JAMA · doi:10.1001/jama.279.20.1615 · Cited by 5,236
(2019) · doi:10.1161/cir.0000000000000677 · Cited by 4,501
Efficacy and safety of low-dose colchicine after myocardial infarction
Tardif, J.-C., Kouz, S., Waters, D. D., Bertrand, O. F., Diaz, R., Maggioni, A. P., Pinto, F. J., Ibrahim, R., Gamra, H., Kiwan, G. S., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1912388 · Cited by 3,159
Collaborators, C. T. T. (. (2012) · The Lancet · doi:10.1016/s0140-6736(12)60367-5 · Cited by 2,833
Colchicine in Patients with Chronic Coronary Disease
Nidorf, S. M., Fiolet, A. T. L., Mosterd, A., Eikelboom, J. W., Schut, A., Opstal, T. S. J., The, S. H. K., Xu, X.-F., Ireland, M. A., Lenderink, T., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2021372 · Cited by 2,299
Prescribing Personalized Nutrition for Cardiovascular Health: Are We Ready?
Juma, S., Imrhan, V., Vijayagopal, P., & Prasad, C. (2014) · Lifestyle Genomics · doi:10.1159/000370213 · Cited by 1,908
2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease
Arnett, D. K., Blumenthal, R. S., Albert, M. A., Buroker, A. B., Goldberger, Z. D., Hahn, E. J., Himmelfarb, C. D., Khera, A., Lloyd-Jones, D., McEvoy, J. W., et al. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.03.010 · Cited by 1,896
Ridker, P. M., Buring, J. E., Rifai, N., & Cook, N. R. (2007) · JAMA · doi:10.1001/jama.297.6.611 · Cited by 1,814
Self-citationBempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
Nissen, S. E., Lincoff, A. M., Brennan, D., Ray, K. K., Mason, D., Kastelein, J. J. P., Thompson, P. D., Libby, P., Cho, L., Plutzky, J., et al. (2023) · New England Journal of Medicine · doi:10.1056/nejmoa2215024 · Cited by 988
Self-citationCholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease
Yusuf, S., Bosch, J., Dagenais, G., Zhu, J., Xavier, D., Liu, L., Pais, P., López-Jaramillo, P., Leiter, L. A., Dans, A., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1600176 · Cited by 848
Bradley, C. K., Wang, T. Y., Li, S., Robinson, J. G., Roger, V. L., Goldberg, A. C., Virani, S. S., Louie, M. J., Lee, L. V., Peterson, E. D., et al. (2019) · Journal of the American Heart Association · doi:10.1161/jaha.118.011765 · Cited by 286
Self-citationNicholls, S., Lincoff, A. M., Bays, H. E., Cho, L., Grobbee, D. E., Kastelein, J. J., Libby, P., Moriarty, P. M., Plutzky, J., Ray, K. K., et al. (2021) · American Heart Journal · doi:10.1016/j.ahj.2020.10.060 · Cited by 136
Self-citationByrne, P., Demasi, M., Jones, M., Smith, S. M., O’Brien, K. K., & DuBroff, R. (2022) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2022.0134 · Cited by 114
Pokharel, Y., Tang, F., Jones, P. G., Nambi, V., Bittner, V. A., Hira, R. S., Nasir, K., Chan, P. S., Maddox, T. M., Oetgen, W. J., et al. (2017) · JAMA Cardiology · doi:10.1001/jamacardio.2016.5922 · Cited by 107
Jacobs, J. A., Addo, D. K., Zheutlin, A. R., Derington, C. G., Essien, U. R., Navar, A. M., Hernandez, I., Lloyd-Jones, D. M., King, J. B., Rao, S., et al. (2023) · JAMA Cardiology · doi:10.1001/jamacardio.2023.0228 · Cited by 97
Navar, A. M., Wang, T. Y., Li, S., Robinson, J. G., Goldberg, A. C., Virani, S., Roger, V. L., Wilson, P. W. F., Elassal, J., Lee, L. V., et al. (2017) · American Heart Journal · doi:10.1016/j.ahj.2017.08.005 · Cited by 94
Yebyo, H. G., Aschmann, H. E., & Puhan, M. A. (2019) · Annals of Internal Medicine · doi:10.7326/m18-1279 · Cited by 73
Virani, S. S., Kennedy, K. F., Akeroyd, J. M., Morris, P. B., Bittner, V. A., Masoudi, F. A., Stone, N. J., Petersen, L. A., & Ballantyne, C. M. (2018) · Circulation: Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.118.004652 · Cited by 53
Statins for primary prevention of cardiovascular disease
Byrne, P., Cullinan, J., & Smith, S. M. (2019) · BMJ · doi:10.1136/bmj.l5674 · Cited by 53
Gamboa, C. M., Safford, M. M., Levitan, E. B., Mann, D. M., Yun, H., Glasser, S. P., Woolley, J. M., Robert, R., Farkouh, M., & Muntner, P. (2014) · The American Journal of the Medical Sciences · doi:10.1097/maj.0000000000000292 · Cited by 50
Statins for Primary Prevention: The Debate Is Intense, but the Data Are Weak
Redberg, R. F., & Katz, M. H. (2017) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2016.7585 · Cited by 22
Langsted, A., Freiberg, J. J., & Nordestgaard, B. G. (2017) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2016.11.025 · Cited by 21
Cited by
Sorted by citations
Martin, S. S., Aday, A. W., Allen, N. B., Almarzooq, Z., Anderson, C. A. M., Arora, P. K., Avery, C. L., Baker-Smith, C. M., Bansal, N., Beaton, A., et al. (2025) · Circulation · doi:10.1161/cir.0000000000001303 · Cited by 1,284
10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2024
American Diabetes Association Professional Practice Committee, ElSayed, N. A., Aleppo, G., Bannuru, R. R., Bruemmer, D., Collins, B. S., Das, S. R., Ekhlaspour, L., Hilliard, M. E., Johnson, E. L., et al. (2024) · Diabetes Care · doi:10.2337/dc24-s010 · Cited by 438
Bushnell, C., Kernan, W. N., Sharrief, A. Z., Chaturvedi, S., Cole, J. W., Cornwell, W. K., Cosby-Gaither, C., Doyle, S., Goldstein, L. B., Lennon, O. C., et al. (2024) · Stroke · doi:10.1161/str.0000000000000475 · Cited by 443
10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Das, S. R., Echouffo-Tcheugui, J. B., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s010 · Cited by 339
Palaniappan, L. P., Allen, N. B., Almarzooq, Z., Anderson, C. A. M., Arora, P. K., Avery, C. L., Baker-Smith, C. M., Bansal, N., Currie, M. E., Earlie, R. S., et al. (2026) · Circulation · doi:10.1161/cir.0000000000001412 · Cited by 343
Metadata
- Authors
- Nissen, S. E., Menon, V., Nicholls, S. J., Brennan, D., Laffin, L., Ridker, P., Ray, K. K., Mason, D., Kastelein, J. J. P., Cho, L., Libby, P., Li, N., Foody, J., Louie, M. J., & Lincoff, A. M.
- Affiliations
- Cleveland Clinic (US)
- Monash University (AU)
- Brigham and Women's Hospital (US)
- Imperial College London (GB)
- Amsterdam UMC Location University of Amsterdam (NL)
- Esperion Therapeutics (United States) (US)
- Corresponding author
- Nissen, Steven E.
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2023-07-11
- Volume
- 330
- Issue
- 2
- Pages
- 131
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC10336623
- OpenAlex
- W4381888526
- Semantic Scholar
- 848bfab6da10e7efa5c7743224564429a99ff2c7
- Cited by
- 146
- References
- 26
- Citations by year
- 2026: 34 · 2025: 42 · 2024: 39 · 2023: 30
- FWCI
- 34.39
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- PubMed Central (submittedVersion)
- Funders
- Esperion Therapeutics
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
- Keywords
- bempedoic acid, statin intolerance, primary prevention, cardiovascular events, LDL cholesterol lowering, high-sensitivity C-reactive protein, myocardial infarction, stroke, cardiovascular mortality, coronary revascularization, hypercholesterolemia, dyslipidemia, cardiovascular risk reduction
- MeSH terms
- Aged, Cardiovascular Diseases, Dicarboxylic Acids, Fatty Acids, Female, Humans, Male, Myocardial Infarction, Primary Prevention, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Stroke
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.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
