Bempedoic acid in patients with type 2 diabetes mellitus, prediabetes, and normoglycaemia: A post hoc analysis of efficacy and glycaemic control using pooled data from phase 3 clinical trials. Issue 5 (3rd February 2022)

• Record Type: Journal Article
• Authors: Leiter, Lawrence A.; Banach, Maciej; Catapano, Alberico L.; Duell, P. Barton; Gotto, Antonio M.; Laufs, Ulrich; Mancini, G. B. John; Ray, Kausik K.; Hanselman, Jeffrey C.; Ye, Zhan; Bays, Harold E.
• Is Part Of: Diabetes, obesity & metabolism. Volume 24:Issue 5(2022)
• Page Start: 868
• Page End: 880
• Publication Date: 2022-02-03
• Subjects: cardiovascular disease -- lipid‐lowering therapy -- statins -- type 2 diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14645
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract: Aim: To evaluate the effect of bempedoic acid on glycaemic and lipid variables in patients with hypercholesterolaemia. Methods: A patient‐level pooled analysis of four phase 3, randomized, double‐blind, placebo‐controlled trials evaluated changes in glycaemia, change from baseline in LDL‐C, and adverse events. Patients ( N = 3621) on maximally tolerated statins were randomized 2:1 to oral bempedoic acid 180 mg or placebo once daily for 12 to 52 weeks with the results analysed by baseline glycaemic status (diabetes, prediabetes, or normoglycaemia). Results: The annual rate of new‐onset diabetes for bempedoic acid versus placebo in patients with normoglycaemia at baseline ( n = 618) was 0.3% versus 0.8%, and for patients with prediabetes at baseline ( n = 1868) it was 4.7% versus 5.9%. In patients with diabetes or prediabetes, bempedoic acid significantly ( P < .0001) reduced HbA1c by −0.12% and −0.06%, respectively, and did not worsen fasting glucose versus placebo. Bempedoic acid significantly and consistently lowered LDL‐C levels versus placebo, regardless of baseline glycaemic status (placebo‐corrected difference range, −17.2% to −29.6%; P < .001 for each stratum). The safety of bempedoic acid was comparable with placebo and similar across glycaemic strata. Conclusions: Bempedoic acid significantly lowered LDL‐C across glycaemic strata and did not worsen glycaemic variables or increase the incidence of new‐onset diabetes versus placebo over a median follow‐up of 1 year.