Alirocumab (Praluent; Sanofi and Regeneron) significantly reduced the risk of major adverse cardiovascular events (MACE) in recent acute coronary syndrome (ACS) patients, according to data presented at the American College of Cardiology’s 67th Annual Scientific Session.
The ODYSSEY Outcomes trial (N=18,924) evaluated the effect of alirocumab on the occurrence of MACE in patients who had an ACS between 1–12 months prior to trial enrollment, and who were already taking maximally-tolerated statins (atorvastatin or rosuvastatin). Patients were randomized to alirocumab or placebo for an average of 2.8 years. The primary outcome was time to first occurrence of coronary heart disease (CHD) death, nonfatal myocardial infarction, unstable angina requiring hospitalization or ischemic stroke.
Treatment with alirocumab lowered the overall risk of MACE by 15% (hazard ratio [HR] 0.85, 95% CI: 0.78–0.93; P=0.0003), meeting the primary endpoint. Alirocumab was also associated with a reduced risk of all-cause mortality (HR 0.85, 95% CI: 0.73–0.98; P=0.026) and fewer CHD deaths (HR 0.92, 95% CI: 0.76–1.11; P=0.38). Specifically, patients with baseline LDL levels ≥100mg/dL saw a more pronounced effect with alirocumab, as demonstrated by a 24% MACE risk reduction (HR 0.76, 95% CI: 0.65–0.87) and a 29% reduction in all-cause mortality (HR 0.71, 95% CI: 0.56–0.90).
Moreover, there were no new safety signals reported in the trial; no difference was seen between the alirocumab and placebo groups with regard to neurocognitive events (1.5% vs. 1.8%) or new-onset diabetes (9.6% vs. 10.1%).
Alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is currently approved as adjunct to diet and maximally tolerated statin therapy, in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease requiring additional lowering of LDL-C.
Steg P, Szarek M, Bhatt D, et al. Cardiovascular Outcomes with Alirocumab After After Acute Coronary: Results of the ODYSSEY Outcomes Trial. Presented at: ACC.18 Scientific Sessions & Expo. March 10–12, 2018; Orlando, FL. Abstract #401-08.