Alirocumab tied to CVD event decrease after ACS in patients with DM

  • Ray KK & al.
  • Lancet Diabetes Endocrinol
  • 1 Jul 2019

  • International Clinical Digest
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  • 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.

Study design

  • 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.

Key results

  • 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.