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
Author(s)
Type
Journal Article
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.
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.
Date Issued
2022-05-01
Date Acceptance
2022-01-01
Citation
Diabetes, Obesity and Metabolism, 2022, 24 (5), pp.868-880
ISSN
1462-8902
Publisher
Wiley
Start Page
868
End Page
880
Journal / Book Title
Diabetes, Obesity and Metabolism
Volume
24
Issue
5
Copyright Statement
© 2022 Esperion Therapeutics, Inc. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/34981622
Subjects
ASSOCIATION
cardiovascular disease
CARDIOVASCULAR-DISEASE
COLLABORATIVE ATORVASTATIN
DENSITY-LIPOPROTEIN-CHOLESTEROL
Endocrinology & Metabolism
HYPERCHOLESTEROLEMIA
Life Sciences & Biomedicine
lipid-lowering therapy
METAANALYSIS
PCSK9
RISK
SAFETY
Science & Technology
statins
STATINS
type 2 diabetes
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2022-01-03