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Cited by 1Lipoproteins and Cardiovascular HealthCholesterol and Lipid MetabolismCancer, Lipids, and Metabolism

Systematic literature review on the real-world effectiveness and safety of bempedoic acid

Open access
Cicero, Arrigo Francesco Giuseppe, Cannon, Christopher P., Gautam, Raju, Anwar, Saeed, Ghatak, Aishee, Sarnes, Evelyn, Powell, Heather A., Chhabra, Richa +1 more·2026·Atherosclerosis Plus
DOI 10.1016/j.athplu.2026.100562PMC PMC13101281
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Abstract

Background and aims: Cardiovascular disease remains a significant global health burden. Bempedoic acid is a novel, oral adenosine triphosphate-citrate lyase inhibitor that lowers low-density lipoprotein cholesterol (LDL-C). While randomized controlled trials (RCTs) have established its efficacy and safety, evidence from real-world clinical practice is needed. Methods: A systematic literature review (SLR) was conducted to identify studies reporting real-world use of bempedoic acid as monotherapy, in fixed dose combination with ezetimibe, or in combination with any other lipid lowering therapy (LLT). MEDLINE, EMBASE, and Cochrane Library were searched from inception to February 19, 2025. Two reviewers independently screened studies, with discrepancies resolved by a third. Data extraction and validation were conducted, and the risk of bias assessed using the Newcastle-Ottawa Scale. Results: Of 269 records, 28 reports on 22 unique studies met the eligibility criteria. Most studies evaluated LDL-C changes from baseline after initiation of bempedoic acid; one pragmatic randomized trial was identified. Bempedoic acid achieved LDL-C reductions of 15% to 39% when added to maximally tolerated statins, 22% to 38% in statin intolerant cohorts, and 18% to 42% in mixed statin intolerant cohorts. Safety data was limited; treatment discontinuation ranged from 9% to 36%, with higher rates in cohorts with greater statin-intolerance. Discussion: This SLR shows bempedoic acid, with or without other LLTs, achieves a minimum of approximately 20% LDL-C reductions, consistent with RCTs. Data suggests it may be effective as an adjunct to statins and as an oral alternative for statin-intolerant patients.

AI snapshot

Written from the paper’s full text.

TL;DR

This systematic literature review found that real-world use of bempedoic acid, with or without other lipid-lowering therapies, generally achieved at least approximately 20% LDL-C reductions, consistent with randomized trial evidence. Safety reporting was limited, but treatment discontinuation ranged from 9% to 36% and was higher in more statin-intolerant cohorts.

Key findings

  • From 269 records, 28 reports on 22 unique studies met eligibility; most evaluated LDL-C change from baseline after bempedoic acid initiation, and one pragmatic randomized trial was identified.
  • Bempedoic acid achieved LDL-C reductions of 15% to 39% when added to maximally tolerated statins, 22% to 38% in statin-intolerant cohorts, and 18% to 42% in mixed statin-intolerant cohorts.
  • LDL-C target attainment varied: in the pragmatic trial, 63% on bempedoic acid vs 37% on statin titration achieved <70 mg/dL at 3 months (p = 0.034); in statin-naïve ACS patients on triple therapy, 71.9% achieved <50 mg/dL and 92.6% achieved <70 mg/dL within 1 month.
  • Safety data were limited; treatment discontinuation ranged from 9% to 36%, with higher rates in cohorts with greater statin intolerance. Reported adverse events included myalgia in 6% (12/200), gout in approximately 2% to 3%, elevated liver enzymes in 1.2% to 3%, cholelithiasis in 2.7% (2/65), and new-onset diabetes in 2% (4/200).

Methods

  • Systematic literature review following Cochrane Handbook and PRISMA 2020; MEDLINE, EMBASE, CENTRAL, and CDSR were searched via Ovid from inception to February 19, 2025, with additional congress abstract searches (2022–2024) and reference-list cross-checking.
  • Eligible studies included adults with primary hypercholesterolemia or mixed dyslipidemia and/or ASCVD; bempedoic acid as monotherapy, fixed-dose combination with ezetimibe, or combination with any other lipid-lowering therapy; real-world observational studies including pragmatic clinical trials; English language.
  • Two reviewers independently screened and extracted data, with discrepancies resolved by consensus or a third reviewer; risk of bias was assessed with the Newcastle–Ottawa Scale. A meta-analysis was not conducted due to heterogeneity, and a narrative synthesis was performed; hsCRP, cardiovascular events, and all-cause mortality were excluded from synthesis because fewer than three studies reported them.

Limitations

  • The paper states that the evidence base was heterogeneous in design, populations, baseline LDL-C, cardiovascular risk, definitions of statin intolerance, and reporting of background lipid-lowering therapy; many studies were conference abstracts, only one open pragmatic randomized trial was identified, cardiovascular and mortality reporting was often incomplete, tolerability data were inconsistently captured, LDL-C targets varied across studies, and publication/reporting bias may be present.
  • The paper also notes that an updated systematic literature review is warranted because additional studies have been published since the February 19, 2025 search cut-off.
  • Evident from the text: safety findings were based on a small number of studies and should be interpreted with caution; sample sizes ranged from 15 to 1515 patients, with several subgroup analyses based on very small numbers; and most included studies evaluated outcomes relative to baseline rather than providing comparative effectiveness data.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1016/j.athplu.2026.100562

Cites

50 of 51 references verified1 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

51 of 122 cited sources checked · 20 supported · 2 flagged · accuracy not yet measured

  • Study design and conductcitation

    In a small prospective study (n=15) in high cardiovascular risk patients with statin intolerance, after 3 months only 8 patients remained on bempedoic acid.

    “After 3 months, only 8 patients remained on bempedoic acid; these patients achieved a 32.3% LDL-C reduction (baseline LDL-C = 179.0 mg/dL) [35].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [35] Mccarron, 2022, Real world efficacy of bempedoic acid in statin-intolerant patients with high cardiovascular risk, Atherosclerosis source

      The paper’s Abstract reports that 10 of 15 patients were still taking bempedoic acid at approximately three months, not eight. Eight was the number of continuing patients whose LDL cholesterol fell; that subgroup had a mean reduction of 32.3%. (LLM, conf=0.91)

      Checked by a reasoning model — may be wrong.

      Experimental — accuracy not yet measured
  • Findingcitation

    In a study of patients with primary hypercholesterolemia or mixed dyslipidemia, most of whom were statin intolerant (93%), 58.0% on bempedoic acid, initiated in line with the Summary of Product Characteristics, achieved an LDL-C target of <70 mg/dL (baseline LDL-C = 155 mg/dL).

    “A second study in patients with primary hypercholesterolemia or mixed dyslipidemia, most of whom were statin intolerant (93%) found that 58.0% on bempedoic acid, initiated in line with the Summary of Product Characteristics achieved a target of <70 mg/dL (baseline LDL-C = 155 mg/dL) [40].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [40] Ramachandran, 2024, A UK multicentre audit of the management of patients with primary hypercholesterolaemia or mixed dyslipidaemia with bempedoic acid against published lipid-lowering treatment targets, Drugs Context source

      Split into 2 atoms — 1 confirmed, 0 partially supported, 1 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Checked by a reasoning model — may be wrong.

      Experimental — accuracy not yet measured
  • Premisecitation

    Bempedoic acid has generally been well tolerated.

    “The drug has generally been well tolerated, although an increased risk of gout has been observed [18].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [18] De Filippo, 2023, Safety and efficacy of bempedoic acid: a systematic review and meta-analysis of randomised controlled trials, Cardiovasc Diabetol source
  • Premisecitation

    An increased risk of gout has been observed with bempedoic acid.

    “The drug has generally been well tolerated, although an increased risk of gout has been observed [18].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [18] De Filippo, 2023, Safety and efficacy of bempedoic acid: a systematic review and meta-analysis of randomised controlled trials, Cardiovasc Diabetol source
  • Premisecitation

    The CLEAR Outcomes trial demonstrated a significant reduction in MACE compared with placebo in patients who are statin intolerant.

    “Clinical trials have shown bempedoic acid reduces LDL-C levels and the CLEAR Outcomes trial demonstrated a significant reduction in MACE compared with placebo in patients who are statin intolerant [[12], [13], [14], [15],17].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [17] Nissen, 2023, Bempedoic acid and cardiovascular outcomes in statin-intolerant patients, N Engl J Med source
  • Classified as probably not a substantial claim. 33
  • May combine two claims. 24

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    The systematic literature review followed the guidance of the Cochrane Handbook and the reporting requirements of PRISMA 2020.

    “The SLR followed the guidance outlined in the Cochrane Handbook [19], and the reporting requirements of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines [20].”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [19] Higgins, 2024

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [20] Page, 2021, PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews, BMJ source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One study had data that contributed to two treatment groups.

    “of note, one study had data that contributed to two groups [30]:”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [30] Russo, 2025, Clinical utilization and performance of bempedoic acid in an Italian real-world setting: insight from Campania Region, J Clin Med source

  • May combine two claims.

    Findingcitation

    In that study, over half (54%) of patients continued statins, the majority on low- (74%) or medium-intensity statins (13%).

    “over half (54%) of patients continued statins, the majority on low- (74%) or medium-intensity statins (13%), while others received background LLTs including ezetimibe [40].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [40] Ramachandran, 2024, A UK multicentre audit of the management of patients with primary hypercholesterolaemia or mixed dyslipidaemia with bempedoic acid against published lipid-lowering treatment targets, Drugs Context source

      The Results (Patient demographics and clinical characteristics; page unavailable) report that 74% (40/54) of patients receiving concomitant statins were on low-intensity statins, and that ezetimibe was a common ongoing therapy. The Discussion (Summary of main results; page unavailable) says 51% of patients with documented ongoing lipid-lowering therapy remained on statins—not 54% of all patients. The passages found do not substantiate the stated 13% on medium-intensity statins. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Findingcitation

    Across two real-world studies involving patients with varied statin tolerability, the proportion achieving LDL-C targets on bempedoic acid ranged from 12.0% reaching <55 mg/dL after 3 months to 20.5% achieving <70 mg/dL after 12 months (baseline LDL-C = 120 mg/dL for the latter).

    “Across two real-world studies involving patients with varied statin tolerability, the proportion achieving LDL-C targets on bempedoic acid, ranged from 12.0% reaching <55 mg/dL [33] to 20.5% achieving <70 mg/dL (baseline LDL-C = 120 mg/dL) [23] after 3 [33], and 12 months of treatment [23].”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [33] Gatto, 2024, LDL target in patients with HIV at high cardiovascular risk: the role of bempedoic acid, Eur Heart J Suppl source
    • cites [23] Warden, 2022, Real-world utilization of bempedoic acid in an academic preventive cardiology practice, J Clin Lipidol source

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    The 2025 ESC/EAS guidelines provide new recommendations for bempedoic acid in both patients unable to take statins and as an adjunct to maximally tolerated statin therapy, with or without ezetimibe, including use in high- and very high-risk patients.

    “The 2025 ESC/EAS guidelines for the management of dyslipidemia provide new recommendations for bempedoic acid in both patients unable to take statins and as an adjunct to maximally tolerated statin therapy, with or without ezetimibe, including use in high- and very high-risk patients [45].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [45] Mach, 2025, 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias, Eur Heart J source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The 2025 ESC/EAS guidelines highlight that variability in LDL-C lowering is observed across all treatment options, likely reflecting differences in background LLT regimens.

    “Importantly, the guidelines highlight that variability in LDL-C lowering is observed across all treatment options, likely reflecting differences in background LLT regimens [45].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [45] Mach, 2025, 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias, Eur Heart J source

      In the pharmacological LDL-C-lowering recommendations (page not provided), the guidelines state that there is considerable inter-individual variability in response to any lipid-lowering drug or combination. They do not attribute that variability to differences in background lipid-lowering therapy regimens, so the proposed explanation is unsupported. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    A recent discrete choice experiment found that patients expressed a strong preference for daily oral non-statin LLT, with a willingness-to-pay of $131 to $175 per month for an oral option that achieved an approximate 25% reduction in LDL-C levels.

    “A recent discrete choice experiment found that patients expressed a strong preference for daily oral non-statin LLT, with a willingness-to-pay of $131 to $175 per month for an oral option that achieved an approximate 25% reduction in LDL-C levels [46].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [46] Reed, 2025, Quantifying patient preferences about features of nonstatin lipid-lowering therapies: a discrete choice experiment in the United States, Circ Cardiovasc Qual Outcomes source

      Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The 2025 ESC/EAS guidelines position bempedoic acid alongside other established LLTs with demonstrated cardiovascular-risk reduction such as statins, ezetimibe, and PCSK9i.

    “The recommendations position bempedoic acid alongside other established LLTs with demonstrated cardiovascular-risk reduction such as statins, ezetimibe, and PCSK9i.”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [45] Mach, 2025, 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias, Eur Heart J source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The 2025 ESC/EAS guidelines recommend that the choice of treatment should not only be made based on the magnitude of additional LDL-C lowering needed, but also patient preference, treatment availability, and cost.

    “Guidelines also recommend that the choice of treatment should not only be made based on the magnitude of additional LDL-C lowering needed, but also patient preference, treatment availability, and cost [45].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [45] Mach, 2025, 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias, Eur Heart J source

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    The 2025 ESC/EAS guidelines emphasize the importance of monitoring LDL-C response 4 to 6 weeks after initiation or intensification and making timely treatment adjustments to achieve recommended targets.

    “In line with this, they emphasize the importance of monitoring LDL-C response 4 to 6 weeks after initiation or intensification and making timely treatment adjustments to achieve recommended targets [45].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [45] Mach, 2025, 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias, Eur Heart J source

      The post-ACS treatment section says LDL-C should be checked 4–6 weeks after starting or intensifying lipid-lowering therapy, and advocates early intensification to reach LDL-C goals. The citing sentence presents this as an unqualified guideline recommendation, whereas the passage places the 4–6-week check in the context of care after acute coronary syndrome; it does not explicitly link that check to subsequent treatment adjustments. No page number is available in our copy. (LLM, conf=0.85)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisecitation

    Bempedoic acid has also been shown to provide improved lifetime cardiovascular risk reduction compared with standard of care at common cost-effectiveness thresholds ($150,000 per QALY), with additional value when combined with ezetimibe ($40,000 per QALY), and in those with statin-intolerance or those with heterozygous familial hypercholesterolemia.

    “Further, bempedoic acid has also been shown to provide improved lifetime cardiovascular risk reduction compared with standard of care at common cost-effectiveness thresholds ($150,000 per QALY), with additional value when combined with ezetimibe ($40,000 per QALY), and in those with statin-intolerance or those with heterozygous familial hypercholesterolemia [47].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [47] Nicholls, 2025, Cost-Effectiveness of bempedoic acid in high cardiovascular risk patients with Statin intolerance: an analysis of the CLEAR outcomes trial, Am J Cardiovasc Drugs source

      The Abstract Results and Conclusions report improved lifetime cardiovascular outcomes versus standard care and a modeled $40,317-per-QALY estimate for the ezetimibe combination. But the list-price estimate was $166,830 per QALY—above the $150,000 threshold—and the Discussion says discounted prices fell below it. The analysis concerns patients with statin intolerance; heterozygous familial hypercholesterolemia appears in a cited report’s title, not as a population evaluated in this paper. (LLM, conf=0.90)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    The most common reasons for exclusion were lack of relevant outcomes or outcome data (n = 18) and irrelevant intervention (n = 13).

    “The most common reasons for exclusion were lack of relevant outcomes or outcome data (n = 18) and irrelevant intervention (n = 13).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One study focusing on HIV reported HIV in 100% of patients.

    “and one study focusing on HIV reported HIV in 100% of patients [28].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [28] Demeure, 2023, Real-life experience of the first patients treated with Bempedoic acid in 2 lipid clinics of Belgium, Atherosclerosis source

  • May combine two claims.

    Findingown data

    This SLR identified real-world studies on the use of bempedoic acid worldwide, including in the United Kingdom (n = 6), India (n = 4), Italy (n = 5), Germany (n = 3), the United States (n = 2) and one study each in Belgium and Spain.

    “This SLR identified real-world studies on the use of bempedoic acid worldwide, including in the United Kingdom (n = 6) [23,27,35,37,40,41], India (n = 4) [29,38,39,42], Italy (n = 5) [24,30,32,33,44], Germany (n = 3) [25,36,43], the United States (n = 2) [31,34] and one study each in Belgium [28] and Spain [26].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    Of the 181 unique records screened, 67 reports were assessed for eligibility, and 46 were subsequently excluded for not meeting the inclusion criteria.

    “Of these, 67 reports were assessed for eligibility, and 46 were subsequently excluded for not meeting the inclusion criteria.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    An additional 57 records were identified from other sources, of which 7 met the eligibility criteria and were included.

    “An additional 57 records were identified from other sources, of which 7 met the eligibility criteria and were included.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Sample sizes ranged from 15 to 1515 patients across studies.

    “Sample sizes ranged from 15 to 1515 patients across studies.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    After removing duplicate records, 181 unique records were screened.

    “After removing duplicate records, 181 unique records were screened.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Fourteen studies were published as conference abstracts.

    “The majority of studies were published as conference abstracts (n = 14) [24,[26], [27], [28], [29],[31], [32], [33], [34], [35], [36], [37], [38],43], with only a subset (n = 8) available as full-text peer-reviewed articles [23,25,30,[39], [40], [41], [42],44].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    One pragmatic randomized trial was identified among the included studies.

    “Most studies evaluated LDL-C changes from baseline after initiation of bempedoic acid; one pragmatic randomized trial was identified.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The remaining studies did not report on number of study sites.

    “Thirteen studies were conducted within single-center institutions [[23], [24], [25], [26],29,33,34,[36], [37], [38], [39],42,44], five studies were in two or more centers [28,30,40,41,43]; the remaining studies did not report on number of study sites [27,31,32,35].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Ten studies were retrospective.

    “Twelve studies used prospective data collection [24,25,30,32,33,35,38,39,[41], [42], [43], [44]], and the remaining 10 studies were retrospective studies [23,[26], [27], [28], [29],31,34,36,37,40].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Where reported, the mean or median ages of patients ranged from 54 to 68 years.

    “Where reported, the mean or median ages ranged from 54 to 68 years.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Five studies were conducted in two or more centers.

    “Thirteen studies were conducted within single-center institutions [[23], [24], [25], [26],29,33,34,[36], [37], [38], [39],42,44], five studies were in two or more centers [28,30,40,41,43]; the remaining studies did not report on number of study sites [27,31,32,35].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    A total of 269 records were identified through database searching, of which 88 were duplicate records across bibliographic sources.

    “A total of 269 records were identified through database searching, of which 88 were duplicate records across bibliographic sources.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Thirteen studies were conducted within single-center institutions.

    “Thirteen studies were conducted within single-center institutions [[23], [24], [25], [26],29,33,34,[36], [37], [38], [39],42,44], five studies were in two or more centers [28,30,40,41,43]; the remaining studies did not report on number of study sites [27,31,32,35].”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingcitation

    In that study, all patients were on ezetimibe and 16% were on PCSK9i.

    “All patients were on ezetimibe and 16% were on PCSK9i [24].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [24] Donnarumma, 2024, Treatment with Bempedoic acid in patients with statin intolerance: preliminary report of a single centre real world study, Atherosclerosis source

  • May combine two claims.

    Findingcitation

    In a large retrospective analysis of patients with a prescription claim for bempedoic acid, bempedoic acid monotherapy reduced LDL-C by 18.0% at 3 months, with reductions sustained at 12 months (p<0.0001).

    “In a large retrospective analysis of patients with a prescription claim for bempedoic acid, regardless of cardiovascular risk status, bempedoic acid monotherapy reduced LDL-C by 18.0% at 3 months (baseline LDL-C = 137 mg/dL), with reductions sustained at 12 months versus baseline (p < 0.0001) [31].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [31] Nelson, 2024, Real-world effectiveness of bempedoic acid and bempedoic acid plus ezetimibe on low-density lipoprotein cholesterol using claims-linked electronic health record data, J Manag Care Spec Pharm source

  • May combine two claims.

    Findingcitation

    In that analysis, patients on bempedoic acid plus ezetimibe achieved a 28.0% reduction at 3 months, with reductions of 22% sustained at 12 months (p<0.001).

    “Patients on bempedoic acid plus ezetimibe achieved a 28.0% reduction at 3 months, with reductions of 22% sustained at 12 months versus baseline (baseline LDL-C = 131 mg/dL) (p < 0.001) [31].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [31] Nelson, 2024, Real-world effectiveness of bempedoic acid and bempedoic acid plus ezetimibe on low-density lipoprotein cholesterol using claims-linked electronic health record data, J Manag Care Spec Pharm source

  • May combine two claims.

    Findingown data

    Bempedoic acid has consistent LDL-C-lowering effects and a tolerability profile as observed in this real-world SLR.

    “Its consistent LDL-C–lowering effects and tolerability profile as observed in this real-world SLR, and favorable oral route of administration make it a practical and accessible option within lipid management pathways.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    Risk of bias was assessed using the Newcastle-Ottawa Scale.

    “Risk of bias was assessed using the Newcastle–Ottawa Scale (NOS), which evaluates observational studies across three domains: selection, comparability, and outcome (for cohort studies) or exposure (for case-control studies) [22].”
    • Also stated in: § Methods · plain
      “Data extraction and validation were conducted, and the risk of bias assessed using the Newcastle–Ottawa Scale.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [22] Wells, 2000

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    The effect measures for LDL-C reduction, LDL-C target, and safety were pre-specified based on their suitability for summarizing real-world observational data across both comparative and non-comparative study designs.

    “These effect measures were pre-specified based on their suitability for summarizing real-world observational data across both comparative and non-comparative study designs.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The chosen effect measures (percentage change from baseline for LDL-C reduction; proportions of patients experiencing the outcome and/or number of events for LDL-C target and safety) are suitable for summarizing real-world observational data across both comparative and non-comparative study designs.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    No limits were applied to the literature search to ensure coverage of studies evaluating bempedoic acid.

    “No limits were applied to ensure coverage of studies evaluating bempedoic acid.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Additional searches were conducted for abstracts presented at relevant scientific congresses hosted between 2022 and 2024.

    “Additional searches were conducted for abstracts presented at relevant scientific congresses hosted between 2022 and 2024 using terms such as “bempedoic”.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Two reviewers independently screened studies at title/abstract and full-text stages, with discrepancies resolved by consensus and a third reviewer consulted as needed.

    “At each stage, two reviewers independently assessed studies for inclusion based on predefined eligibility criteria (SA and AG). Discrepancies were resolved by consensus, with a third reviewer consulted as needed (RG).”
    • Also stated in: § Methods · plain
      “Two reviewers independently screened studies, with discrepancies resolved by a third.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationreasoning

    This systematic literature review shows that bempedoic acid, with or without other lipid-lowering therapies, achieves a minimum of approximately 20% LDL-C reductions, consistent with randomized controlled trials.

    “This SLR shows bempedoic acid, with or without other LLTs, achieves a minimum of approximately 20% LDL-C reductions, consistent with RCTs.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    Each study was independently assessed for risk of bias by one reviewer and verified by the other, with discrepancies resolved by consensus and a third reviewer as needed.

    “Each study was independently assessed by one reviewer (SA or AG) and verified by the other. Discrepancies were resolved by consensus, with a third reviewer consulted as needed (RG).”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Literature searches were conducted via Ovid in MEDLINE, EMBASE, CENTRAL and CDSR from database inception until February 19, 2025.

    “The literature searches were conducted via Ovid in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and Cochrane Database of Systematic Reviews (CDSR), from database inception until February 19, 2025.”
    • Also stated in: § Methods · plain
      “MEDLINE, EMBASE, and Cochrane Library were searched from inception to February 19, 2025.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Studies assessed as having a high risk of bias were flagged during the qualitative synthesis.

    “Studies assessed as having a high risk of bias were flagged during the qualitative synthesis of findings.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Data extraction used a standardized template, with one reviewer extracting data and the other independently validating them, and discrepancies resolved by consensus with a third reviewer as needed.

    “Data extraction was performed using a standardized data extraction template developed in Microsoft® Excel. Relevant information from the included studies was extracted by one reviewer (SA or AG) and independently validated by the other. Discrepancies were resolved by consensus, with a third reviewer consulted as needed (RG).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationreasoning

    Data suggest that bempedoic acid may be effective as an adjunct to statins and as an oral alternative for statin-intolerant patients.

    “Data suggests it may be effective as an adjunct to statins and as an oral alternative for statin-intolerant patients.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Study authors cross-checked their own reference lists to identify publications not retrieved through the primary database searches.

    “Study authors also cross-checked their own reference lists to identify any publications not retrieved through the primary database searches.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationreasoning

    The growing body of evidence supports the use of bempedoic acid in clinical practice, both as adjunct to statins and as an oral alternative for patients with statin intolerance.

    “Together, the growing body of evidence supports the use of bempedoic acid in clinical practice, both as adjunct to statins and as an oral alternative for patients with statin intolerance.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationreasoning

    The findings support confidence in the effectiveness and tolerability of bempedoic acid in routine clinical practice.

    “These findings support confidence in its effectiveness and tolerability in routine clinical practice.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationreasoning

    Bempedoic acid can be used both as an adjunct to statins and as an oral option for patients with statin intolerance.

    “It can be used both as an adjunct to statins and as an oral option for patients with statin intolerance.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationreasoning

    Incomplete reporting of cardiovascular outcomes and mortality and inconsistent tolerability data limit assessment of longer-term clinical implications.

    “limiting assessment of longer-term clinical implications.”
    Quote in the paperSubstantial claim
46 of 46

  • The paper relies on this without support.

    Less is known about the real-world use of bempedoic acid than about its efficacy and safety from randomized controlled trials.

    “While randomized controlled trial (RCT) data have established the efficacy and safety of bempedoic acid, less is known about its real-world use.”
    “While randomized controlled trials (RCTs) have established its efficacy and safety, evidence from real-world clinical practice is needed.”

  • The paper relies on this without support.

    The chosen effect measures (percentage change from baseline for LDL-C reduction; proportions of patients experiencing the outcome and/or number of events for LDL-C target and safety) are suitable for summarizing real-world observational data across both comparative and non-comparative study designs.

    “These effect measures were pre-specified based on their suitability for summarizing real-world observational data across both comparative and non-comparative study designs.”

  • The paper relies on this without support.

    The real-world studies included in the SLR provide valid estimates of bempedoic acid's effectiveness and safety.

    “The SLR suggests that in real-world practice, bempedoic acid, with or without other LLTs, achieves a minimum of approximately 20% LDL-C reductions, consistent with the magnitude of effect demonstrated in RCTs.”

  • The paper relies on this without support.

    The observed LDL-C reductions in the included real-world studies are attributable to bempedoic acid rather than to other concurrent changes in lipid-lowering therapy.

    “These reductions were reported across both primary (23% to 39%) [24,29,44] and secondary prevention populations (15% to 39%) [25,32,38,39].”

  • The paper relies on this without support.

    Clinical inertia remains a barrier to LDL-C target attainment in routine practice.

    “Despite clear guidance, clinical inertia remains a barrier to LDL-C target attainment in routine practice.”
5 of 5

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.

  • Cholelithiasis percentage does not match the reported count

    Minor

    Two of 65 patients is approximately 3.1%, not 2.7%.

    Reported 2.7 · recomputed 3.076923

  • Reported baseline LDL-C range excludes a higher value

    Minor

    The stated upper limit is 146 mg/dL, but a later cohort has a reported baseline of 179.0 mg/dL.

  • Reported baseline LDL-C range excludes a lower value

    Minor

    The stated lower limit is 90 mg/dL, but a later study reports a baseline of 78 mg/dL.

  • HIV cohort is attributed to different studies

    Minor

    The text attributes the single HIV-focused study to reference [28], whereas Table 1 identifies the HIV-infected cohort as reference [33].

4 of 4

Cites

Flagged first, then by citations

Research works printed but not linked: 2

  1. Nelson, 2024, Real-world effectiveness of bempedoic acid and bempedoic acid plus ezetimibe on low-density lipoprotein cholesterol using claims-linked electronic health record data, J Manag Care Spec Pharm, 7, 10
  2. Rana, 2025, Bempedoic acid as an adjunct to statin therapy in CAD patients: clinical outcomes and safety profile, Int J Life Sci, 14

Cited by

Sorted by citations

Authors
Cicero, A. F. G., Cannon, C. P., Gautam, R., Anwar, S., Ghatak, A., Sarnes, E., Powell, H. A., Chhabra, R., & Jawla, S.
Affiliations
  • IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
  • Brigham and Women's Hospital (US)
  • Esperion Therapeutics (United States) (US)
  • Daiichi Sankyo (Germany) (DE)
Corresponding author
Cicero, Arrigo Francesco Giuseppe
ORCID
Venue
Atherosclerosis Plus
Publisher
Elsevier BV
Published
2026-09
Volume
65
Pages
100562
ISSN
2667-0895 (ISSN-L)
DOI
10.1016/j.athplu.2026.100562
PMC
PMC13101281
OpenAlex
W7140174700
Semantic Scholar
90072827c584757256ab51556cf7ea8e76f7828e
Cited by
1
References
39
Citations by year
2026: 1
FWCI
2.58
Type
journal article
Language
en
Open access
Licence
Locations
  • Atherosclerosis Plus (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • PubMed Central (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
Daiichi Sankyo Europe GmbH
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
Keywords
bempedoic acid, ATP-citrate lyase inhibitor, LDL cholesterol lowering, statin intolerance, lipid-lowering therapy, real-world effectiveness, drug safety, treatment discontinuation, cardiovascular disease

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.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-19.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-19.

Cited sources are checked by 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 ›

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