# Geen effect van PCSK9-remmer alirocumab op diabetes-incidentie: ODYSSEY-analyse

*geplaatst 2016-10-14 · Cholesterol · European heart journal · doi 10.1093/eurheartj/ehw292 · https://hartvaat.nl/2016/10/14/geen-effect-van-pcsk9-remmer-alirocumab-op-diabetes-incidentie-odyssey-analyse/*

Gepoolde analyse van 10 ODYSSEY fase-3-studies die geen verhoogde incidentie van diabetes aantoonde bij alirocumabgebruik. Geruststellend voor de metabole veiligheid van PCSK9-remmers.

## English: No effect of PCSK9 inhibitor alirocumab on the incidence of diabetes in a pooled analysis from 10 ODYSSEY Phase 3 studies.

This pooled analysis of 10 ODYSSEY phase 3 studies found no increased incidence of diabetes with alirocumab, providing reassurance that PCSK9 inhibitors do not share the diabetogenic effect observed with statins.

## Abstract (original, from the publication)

AIMS: 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. METHODS AND RESULTS: Pooled analysis of 10 ODYSSEY Phase 3 trials (n = 4974) of 24-104 weeks duration. Six trials (n = 4211) were ≥52 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 A1C (HbA1C) was measured at baseline and every 12-24 weeks. Transition to diabetes analysis combined TEAE and FPG/HbA1C 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/HbA1C over time showed no difference between treatment groups in patients without diabetes. CONCLUSIONS: 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.

Auteurs: Helen M Colhoun, Henry N Ginsberg, Jennifer G Robinson, Lawrence A Leiter, Dirk Müller-Wieland, Robert R Henry, Bertrand Cariou, Marie T Baccara-Dinet, Robert Pordy, Laurence Merlet, Robert H Eckel

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Bron: European heart journal, https://doi.org/10.1093/eurheartj/ehw292. Bijgewerkt 2026-07-03T13:25:41Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.