Abstract 16873: Safety and Efficacy of Alirocumab in Patients With Atherosclerotic Cardiovascular Disease, Based on Statin Intensity: Pooled Analyses of 5 Placebo-controlled Phase 3 Trials

Introduction: Atherosclerotic cardiovascular disease (ASCVD) patients are at high risk for recurrent CV events and the 2013 ACC/AHA guidelines recommend at least moderate intensity statin therapy. We examined efficacy and safety of alirocumab (ALI), a PCSK9 inhibitor, in 2100 ASCVD patients on moderate or high intensity concomitant statins. Methods: ASCVD was defined as coronary heart disease, stroke, and peripheral arterial disease. Enrolled patients pooled from 5 Phase 3 placebo (PL)-controlled studies (≥52 Weeks [W]) were on stable maximally tolerated statin ± other lipid-lowering therapies. Mean % LDL-C reduction from baseline to W12 and W24 was analyzed by statin intensity and initial ALI dose. Results: Baseline characteristics were comparable between treatment groups with mean age ~61 years, ~67% male and mean BMI of ~30 kg/m 2 . In a subset of 1431 patients (ALI 150 mg Q2W), baseline mean ± SD free PCSK9 was 322.9 ± 134.2 and 293.5 ± 106.3 ng/ml in high and moderate intensity statin-treated patients, respectively ( P P values between subgroups were not significant, indicating no effect modification between statin intensity and LDL-C reduction (Fig. 1). Common treatment emergent adverse events with ALI were nasopharyngitis, upper respiratory tract infections and injection site reactions (Table 1). Conclusions: Despite slightly increased PCSK9 levels in subset of high vs. moderate intensity statin patients, ALI was comparably efficacious and well-tolerated in ASCVD patients on high or moderate intensity statins.