Bempedoic Acid and Ezetimibe for the Treatment of Hypercholesterolemia: A Systematic Review and Meta-Analysis of Randomized Phase II/III trials

Bhagavathula, Akshaya Srikanth; Matrooshi, Nadya Obaid Al; Clark, Cain C. T.; Rahmani, Jamal

doi:10.1007/s40261-020-00989-1

Cited by 12 publications

(10 citation statements)

References 38 publications

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“…In a pooled analysis of 388 patients, Bhagavathula et al. also noted a significant reduction of LDL-C (− 29.14%, 95% CI −39.52 to −18.76; p <.001) and hsCRP (− 30.48%, 95% CI −44.69 to −16.28; p = .04) with the combination of bempedoic acid and ezetimibe in this patient population, as compared to the control group, after 12 weeks [ 55 ]. In a smaller trial enrolling 59 patients on background therapy with PCSK9 inhibitors, the addition of bempedoic acid showed a further reduction of LDL-C by 30.3% after 2 months of therapy, when compared with placebo [ 56 ].…”

Section: Clinical Development Of Bempedoic Acidmentioning

confidence: 71%

Bempedoic acid and its role in contemporary management of hyperlipidemia in atherosclerosis

et al. 2022

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Atherosclerotic heart disease is the leading cause of mortality and morbidity in the USA. Low density lipoprotein (LDL) has been the target for many hypolipidemic agents to modify atherosclerotic risk. Bempedoic acid is a novel hypolipidemic drug that inhibits the enzymatic activity of ATP citrate lyase in the cholesterol synthesis pathway. CLEAR Harmony, CLEAR Wisdom, CLEAR Tranquillity and CLEAR Serenity have shown safety and efficacy associated with long term administration of this drug. Studies have shown effectiveness in reducing LDL-C in both statin intolerant patients and in patients on maximally tolerated doses of statin. The fixed drug combination of bempedoic acid and ezetimibe in a recent phase III showed significant reduction in LDL compared with placebo, which might be a promising future for LDL reduction among statin intolerant patients. Bempedoic acid also reduced inflammatory markers like hs-CRP. Given these results, bempedoic acid alone and in combination with ezetimibe received the USA FDA approval for adults with heterozygous familial hypercholesterolaemia or established atherosclerotic cardiovascular disease. We present a comprehensive review exploring the underlying mechanism, pre-clinical studies, and clinical trials of bempedoic acid and discuss the potential future role of the drug in treating hyperlipidaemia.

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Section: Clinical Development Of Bempedoic Acidmentioning

confidence: 71%

Bempedoic acid and its role in contemporary management of hyperlipidemia in atherosclerosis

et al. 2022

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“…[26][27][28][29][30] The majority of those focused on BAs capacities in lipid-lowering with comparable results to the current analysis: Allocation to BA as compared with placebo led to highly significant reductions in major atherogenic lipid fractions of LDL-C, non-HDL-C and apoB. [26][27][28][29] In contrast, primary interest of the current meta-analysis was to assess evidence on BAs efficacy in improving relevant clinical outcomes, which is the fundamental objective of pharmacological lipid-lowering. The current work is, along with another recent publication, 30 the first to provide information on this.…”

Section: Discussionmentioning

confidence: 65%

Section: Discussionmentioning

confidence: 75%

“…Several pooled analyses of trials investigating effects of BA have been performed at the same time by other groups 26–30. The majority of those focused on BAs capacities in lipid-lowering with comparable results to the current analysis: Allocation to BA as compared with placebo led to highly significant reductions in major atherogenic lipid fractions of LDL-C, non-HDL-C and apoB 26–29. In contrast, primary interest of the current meta-analysis was to assess evidence on BAs efficacy in improving relevant clinical outcomes, which is the fundamental objective of pharmacological lipid-lowering.…”

Section: Discussionmentioning

confidence: 86%

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Clinical efficacy and safety outcomes of bempedoic acid for LDL-C lowering therapy in patients at high cardiovascular risk: a systematic review and meta-analysis

et al. 2022

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ObjectivesBempedoic acid (BA) is a novel oral low-density lipoprotein cholesterol lowering drug. This systematic review and meta-analysis aims to assess efficacy and safety for clinical outcomes in high cardiovascular (CV) risk patients.Data sourcesMEDLINE, Cochrane Central Register of Controlled Trials, Google Scholar, Embase, ClinicalTrials.gov, Clinical Trial Results and the American College of Cardiology web site were searched.Study selectionRandomised controlled trials (RCTs) of BA versus placebo in high CV risk patients reporting clinical outcomes were included.Main outcomes and measuresPrimary efficacy outcomes were major adverse cardiovascular events (MACE), all-cause mortality, CV mortality and non-fatal myocardial infarction (MI). Safety outcomes included new onset or worsening of diabetes mellitus (DM), muscular disorders, gout and worsening of renal function.ResultsSix RCTs with a total of 3956 patients and follow-ups of four to 52 weeks were identified. Heterogeneity mainly derived from differing follow-up duration and baseline CV risk. No difference in MACE (OR 0.84; 95% CI 0.61 to 1.15), all-cause mortality (OR 2.37; CI 0.80 to 6.99) and CV mortality (OR 1.66; CI 0.45 to 6.04) for BA versus placebo was observed. BA showed beneficial trends for non-fatal MI (OR 0.57; CI 0.32 to 1.00) and was associated with a lower risk of new-onset or worsening of DM (OR 0.68; CI 0.49 to 0.94), but higher risk of gout (OR 3.29; CI 1.28 to 8.46) and a trend for muscular disorders (OR 2.60; CI 1.15 to 5.91) and worsening of renal function (OR 4.24; CI 0.98 to 18.39).ConclusionBA in high CV risk patients showed no significant effects on major CV outcomes in short-term follow-up. Unfavourable effects on muscular disorders, renal function and gout sound a note of caution. Hence, further studies with longer term follow-up in carefully selected populations are needed to clarify the risk/benefit ratio of this novel therapy.

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“…Una RS publicada por Bhagavathula et al en 2021 129 tuvo como objetivo evaluar la eficacia y seguridad del ácido bempedoico y ezetimiba en comparación con placebo o ezetimiba como monoterapia en pacientes con hipercolesterolemia o ECVA establecida. Los autores incluyeron tres ECA fase III (388 participantes).…”

Section: Recomendaciones Clínicasunclassified

Guía de práctica clínica mexicana para el diagnóstico y tratamiento de las dislipidemias y enfermedad cardiovascular aterosclerótica

Pavía-López¹,

Alcocer-Gamba

Ruiz-Gastélum³

et al. 2022

ACM

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Antecedentes: Las enfermedades cardiovasculares son la principal causa mundial de mortalidad y México no es la excepción. Los datos epidemiológicos obtenidos en 1990 mostraron que los padecimientos cardiovasculares representaron el 19.8% de todas las causas de muerte en nuestro país; esta cifra se incrementó de manera significativa a un 25.5% para 2015. Diversas encuestas nacionales sugieren que más del 60% de la población adulta tiene al menos un factor de riesgo para padecer enfermedades cardiovasculares (obesidad o sobrepeso, hipertensión, tabaquismo, diabetes, dislipidemias). Por otro lado,

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Bempedoic Acid and Ezetimibe for the Treatment of Hypercholesterolemia: A Systematic Review and Meta-Analysis of Randomized Phase II/III trials

Cited by 12 publications

References 38 publications

Bempedoic acid and its role in contemporary management of hyperlipidemia in atherosclerosis

Bempedoic acid and its role in contemporary management of hyperlipidemia in atherosclerosis

Clinical efficacy and safety outcomes of bempedoic acid for LDL-C lowering therapy in patients at high cardiovascular risk: a systematic review and meta-analysis

Guía de práctica clínica mexicana para el diagnóstico y tratamiento de las dislipidemias y enfermedad cardiovascular aterosclerótica

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