- Following acute coronary syndrome (ACS), alirocumab (Praluent) treatment is linked to greater absolute cardiovascular event reduction in patients with diabetes mellitus (DM) vs placebo.
- Alirocumab was not associated with new-onset diabetes rates.
Why this matters
- NICE recommends alirocumab as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia if LDL-C concentrations persistently exceed thresholds.
- Prespecified analysis of ODYSSEY OUTCOMES: 5444 patients with baseline diabetes (n=37; type 1), 8246 prediabetes, 5234 normoglycaemic.
- All were post-ACS with elevated low-density lipoprotein cholesterol (LDL-C) despite high-intensity statins.
- Participants were randomly allocated to alirocumab targeting LDL-C (0.65-1.30 mmol/L) vs placebo.
- Mean follow-up 2.8 years.
- Primary endpoint: composite of coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, or unstable angina hospitalization.
- Funding: Sanofi; Regeneron Pharmaceuticals.
- Vs prediabetes, HRs for primary endpoint among patients with diabetes or normoglycaemia: 2.09 (P<.0001 and>
- Relative reduction in primary endpoint with alirocumab was similar with diabetes (0.84; 95% CI, 0.74-0.97), prediabetes (0.86; 0.74-1.00), and normoglycaemia (0.85; 0.70-1.03).
- Absolute risk reduction with alirocumab doubled for diabetes group (2.3%; 95% CI, 0.4%-4.2%) vs prediabetes (1.2%; 0.0%-2.4%) or normoglycaemia (1.2%; –0.3% to 2.7%; overall Pinteraction=.0019).
- New-onset diabetes rates did not differ between alirocumab and placebo (9.6% vs 10.1%; HR, 1.00; 95% CI, 0.89-1.11).
- Low use of newer glucose-lowering agents with cardiovascular benefit.