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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

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 advers...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2022-05, Vol.24 (5), p.868-880
Main 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.
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Language:English
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Summary: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 
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.14645