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Gavalas M, Dangas G Gavalas, Michael, and George Dangas. "Efficacy and Safety of Bempedoic Acid in Patients on Statin Therapy with Hypercholesterolemia and High Cardiovascular Risk." Hurst's the Heart Updates, 16 May 2016. McGraw-Hill, New York, NY, 2016. AccessCardiology. http://accesscardiology.mhmedical.com/updatesContent.aspx?gbosid=477520§ionid=218282378 MLA Citation Gavalas M, Dangas G. Gavalas M, Dangas G Gavalas, Michael, and George Dangas.. "Efficacy and Safety of Bempedoic Acid in Patients on Statin Therapy with Hypercholesterolemia and High Cardiovascular Risk." Hurst's the Heart Updates Fuster V. Fuster V Fuster, Valentin. New York, NY: McGraw-Hill, 2016, http://accesscardiology.mhmedical.com/updatesContent.aspx?gbosid=477520§ionid=218282378. Download citation file: RIS (Zotero) EndNote BibTex Medlars ProCite RefWorks Reference Manager Mendeley © Copyright Tools Clip Full Chapter Figures Only Tables Only Videos Only Supplementary Content Top Efficacy and Safety of Bempedoic Acid in Patients on Statin Therapy with Hypercholesterolemia and High Cardiovascular Risk by Michael Gavalas, George Dangas Listen + +Update to Chapter 29: Hyperlipidemia Study Summary + +The phase 3, double-blind, placebo-controlled, parallel-group CLEAR Wisdom Study sought to evaluate the long-term efficacy and safety of bempedoic acid in high-risk cardiovascular patients (with pre-existing atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia, and baseline low-density lipoprotein cholesterol [LDL-C] greater than 100 mg/dL) receiving maximally tolerated statins with or without other lipid lowering therapy. A total of 779 patients were randomized 2:1 to bempedoic acid 180 mg or placebo daily for 52 weeks; no significant differences were observed between the groups at baseline. Of note, mean LDL-C was 122 mg/dL and 119 mg/dL in the placebo group and treatment group, respectively, and only 53% of patients in each group were on high-intensity statin at baseline. The primary end point was percent change in LDL-C from baseline to week 12 (see accompanying Hurst's Central Illustration). Bempedoic acid showed a net 17.4% reduction in LDL-C at week 12 when compared to placebo (mean LDL-C 122.8 mg/dL vs. 97.6 mg/dL), with sustained reductions seen at 52 weeks (mean LDL-C 116.9 mg/dL vs. 99.6 mg/dL). The largest reduction in LDL-C was seen in patients who were not on statin therapy at baseline. There was also a significantly greater reduction in high-sensitivity-C-reactive protein (hsCRP) seen in the bempedoic acid group compared with placebo (-9.4% vs. -18.7%). Overall, there was no significant difference in safety and tolerability or drug discontinuations due to adverse events of bempedoic acid when compared with placebo. + Hurst’s Central Illustration Graphic Jump LocationView Full Size|Favorite Figure|Download Slide (.ppt) Commentary + +Study Strengths: This study evaluated a high-risk group for whom LDL-C reduction would be most beneficial. The study was double-blinded, placebo-controlled, and international. In addition to LDL-C, the effect of bempedoic acid on non-LDL-C lipids and hsCRP was also measured. +Study Limitations: The study size was modest, with a total of 779 patients. Cardiovascular outcomes were not measured to evaluate if LDL-C reductions with bempedoic acid were associated with fewer major adverse cardiovascular events. The primary end point follow-up was 12 weeks, with 52-week follow-up being a tertiary end point. +Next Steps/Clinical Perspective: Additional studies to assess longer-term durable reductions in LDL-C with bempedoic acid are needed. Clinical correlation with cardiovascular outcomes are also required to evaluate the efficacy of bempedoic acid on cardiovascular outcomes and all-cause mortality in this high-risk population. The role of bempedoic acid in LDL-C reduction and reduction in atherosclerotic cardiovascular disease in patients not on statin therapy should be better evaluated as well, as this drug may be a better alternative (as lone therapy) for patients who are unable to tolerate statin therapy at baseline. The recently published CLEAR Harmony Trial (Ray KK et al. N Engl J Med. 2019;380(11):1022-1032), which primarily assessed the safety of bempedoic acid as compared with placebo and secondarily its efficacy in LDL-C reduction, also suggests that bempedoic acid is well tolerated without a significant difference in adverse effects. Future studies may also compare bempedoic acid against other nonstatin lipid-lowering agents such as ezetimibe and PCSK9 inhibitors.