BACKGROUND: People with diabetes and recent ACS are at higher risk for ischemic CV events and derive greater benefit from intensive lipid-lowering therapy than those without diabetes. Effect of PCSK9 inhibition in patients with recent ACS and diabetes is unknown.
METHODS: Alirocumab (ALI) is a fully human monoclonal antibody to PCSK9. In ODYSSEY OUTCOMES, 18,924 patients with recent ACS and LDLC≥70mg/dL on a maximum-tolerated dose of atorvastatin or rosuvastatin were randomly assigned to ALI 75mg or placebo SC every 2 weeks. ALI blindly increased to 150mg or decreased to placebo to achieve an LDL-C of 25-50mg/dL. Primary efficacy endpoint was time to first MACE: CHD death, nonfatal MI, ischemic stroke or hospitalization for unstable angina. This prespecified analysis reports efficacy and safety by baseline glucometabolic status, including new-onset diabetes (NOD).
RESULTS: Table reports incidence of MACE by assigned treatment and baseline glucometabolic status. Overall ALI reduced MACE, without evidence of effect modification by baseline glucometabolic status: a greater absolute risk reduction was observed with ALI in those with diabetes. NOD was not increased with ALI.
CONCLUSIONS: Patients with recent ACS and diabetes derived greater absolute benefit from ALI added to maximum-tolerated statin. No increase in NOD was seen with ALI (NCT01663402).