For one study, researchers sought to investigate the impact of alirocumab, a PCSK9 inhibitor, versus placebo on major adverse cardiovascular events (MACE) based on baseline metabolic risk variables. The ODYSSEY OUTCOMES experience, a multicenter, double-blind, randomized controlled trial conducted in 1,315 hospitals and outpatient clinics in 57 countries, was analyzed post-hoc. Patients 40 years of age and older who had recently had an acute coronary syndrome (within the previous 1-12 months) and had higher levels of atherogenic lipoproteins despite taking a high-intensity or maximally tolerated statin were eligible. to participate. Patients were randomized (1:1) to receive 75 mg alirocumab by subcutaneous injection every 2 weeks, or matching placebo, beginning 1 to 12 months after acute coronary syndrome and followed for 2.8 years ( IQR 2.3–3.4). Group assignment and modification of treatment dose were kept secret from patients and investigators. The primary outcome was death due to coronary artery disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization. MACE was analyzed using an ordinal number of metabolic risk factors. Blood pressure of 130/85 mm Hg or antihypertensive therapy, triglyceride concentration of at least 150 mg/dL, HDL cholesterol concentration less than 40 mg/dL for men and 50 mg/dL for women, fasting blood sugar d at least 100 mg/dL or treatment with hypoglycemic drugs and a BMI of at least 30 kg/m2 were all considered metabolic risk factors. The number of metabolic risk factors was used to determine the risk of MACE and the effect of alirocumab. Approximately 3882 (41%) of 9462 patients in the alirocumab group and 3859 (41%) of 9462 patients in the placebo group had at least three metabolic risk factors. The incidence of MACE increased monotonically in the placebo group with each metabolic risk factor, from 7.8% (no risk factor) to 19.6% (5 risk factors; HR 1.18; CI at 95% 1.13-1.24 per metabolic risk factor). Alirocumab reduced the relative risk of MACE in all categories defined by the number of metabolic risk factors (pinteraction=0.77). Nevertheless, the absolute risk reduction (aRR) increased with the number of metabolic risk factors (no aRR risk factor 0.7%, -1.81 to 3.29 versus 5 aRR risk factors 3.9%, – 1.45 to 9.25;pinteraction

Source:www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00043-2/fulltext