期刊
EUROPEAN HEART JOURNAL
卷 37, 期 39, 页码 2981-2989出版社
OXFORD UNIV PRESS
DOI: 10.1093/eurheartj/ehw292
关键词
Glycaemia; Diabetes; PCSK9 inhibitor; Low-density lipoprotein cholesterol; HbA(1C); Fasting plasma glucose
资金
- Sanofi
- Regeneron Pharmaceuticals, Inc.
Statins have modest adverse effects on glycaemic control. Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, lowers low-density lipoprotein cholesterol. This study assessed the effects of alirocumab on new-onset diabetes and pre-diabetes incidence in individuals without diabetes at baseline. Pooled analysis of 10 ODYSSEY Phase 3 trials (n = 4974) of 24-104 weeks duration. Six trials (n = 4211) were a parts per thousand yen52 weeks in length. Most patients received background maximally tolerated statin. Alirocumab effect on the rate of diabetes-related treatment-emergent adverse events (TEAEs), and/or fasting plasma glucose (FPG) and glycated haemoglobin A(1C) (HbA(1C)) was measured at baseline and every 12-24 weeks. Transition to diabetes analysis combined TEAE and FPG/HbA(1C) laboratory data. At baseline, 30.7% of individuals had diabetes and were excluded from the current analysis. The remaining 3448 individuals without diabetes had pre-diabetes (39.6%) or were normoglycaemic (29.7%). The hazard ratio (HR; 95% confidence interval) for diabetes-related TEAEs in alirocumab was 0.64 (0.36-1.14) vs. placebo and 0.55 (0.22-1.41) vs. ezetimibe. The HR associated for transition from pre-diabetes to new-onset diabetes for alirocumab was 0.90 (0.63-1.29) vs. placebo and 1.10 (0.57-2.12) vs. ezetimibe. Mean change in FPG/HbA(1C) over time showed no difference between treatment groups in patients without diabetes. There was no evidence of an effect of alirocumab on transition to new-onset diabetes in 3448 individuals without diabetes at baseline with a follow-up period of 6-18 months, compared to either placebo or ezetimibe. Longer follow-up with larger number of individuals is needed to conclusively rule out an effect.
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