No effect of PCSK9 inhibitor alirocumab on the incidence of diabetes in a pooled analysis from 10 ODYSSEY Phase 3 studies
Authors' conclusion
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.
Study context
- Population
- Individuals without diabetes at baseline (pre-diabetes or normoglycaemic), most on background maximally tolerated statin3,448 without diabetes analysed
- Participants
- 4,974 individuals
- Comparison
- Alirocumab vs placebo or ezetimibe
- Outcome
- New-onset diabetes (transition to diabetes, combining diabetes-related treatment-emergent adverse events (TEAEs) and FPG/HbA1C data) and pre-diabetes incidence
Methodological details24-104 weeks duration, Six trials (n = 4211) ≥52 weeks, Baseline: 30.7% had diabetes and were excluded; of the 3448 without diabetes, 39.6% pre-diabetes, 29.7% normoglycaemic
- 24-104 weeks duration
- Six trials (n = 4211) ≥52 weeks
- Baseline: 30.7% had diabetes and were excluded; of the 3448 without diabetes, 39.6% pre-diabetes, 29.7% normoglycaemic
Pooled result
As reported in the abstract
Transition from pre-diabetes to new-onset diabetes
Hazard ratio (95% CI)
Alirocumab vs Placebo
0.90(0.63–1.29)
Alirocumab vs Ezetimibe
1.10(0.57–2.12)
Further pooled results
| Outcome | HR (95% CI) | |
|---|---|---|
| Diabetes-related TEAEsAlirocumab vs Placebo | 0.64 (0.36–1.14) | |
| Diabetes-related TEAEsAlirocumab vs Ezetimibe | 0.55 (0.22–1.41) | |
| 0.20.5125Hazard ratio (log scale) |
Mean change in fasting plasma glucose (FPG)/haemoglobin A1C (HbA1C) over time
- No difference between treatment groups in patients without diabetes
Original publication
No effect of PCSK9 inhibitor alirocumab on the incidence of diabetes in a pooled analysis from 10 ODYSSEY Phase 3 studies. Eur Heart J. Published 26 July 2016. doi:10.
Summarised from the published abstract; every number is checked against it