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/m2. 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<0.0001). Mean LDL-C reductions from baseline in those on high and moderate intensity statins as compared to PL were similar at W12 and W24 (Fig. 1). Interaction 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.
Author Disclosures: C.M. Ballantyne: Consultant/Advisory Board; Modest; Abbott Diagnostics, Amarin, Amgen, Eli Lilly, Esperion, Ionis, Matinas BioPharma Inc, Novartis, Regeneron, Roche Diagnostic. Research Grant; Significant; NIH, AHA, ADA. Other Research Support; Significant; Abbott Diagnostic, Amarin, Amgen, Eli Lilly, Esperion, Ionis, Novartis, Pfizer, Regeneron, Roche Diagnostic, Sanofi-Synthelabo. Consultant/Advisory Board; Significant; Astra Zeneca, Merck, Pfizer, Sanofi-Synthelabo. P.A. McCullough: None. S.K. Sanganalmath: Employment; Significant; Regeneron Pharmaceuticals, Inc. A. Koren: Employment; Significant; Sanofi. A. Letierce: Employment; Significant; Sanofi. M.H. Davidson: Speakers Bureau; Significant; Sanofi, Regeneron Pharmaceuticals, Inc., Amgen. Honoraria; Significant; Sanofi, Regeneron Pharmaceuticals, Inc., Amgen. Consultant/Advisory Board; Modest; Sanofi, Regeneron Pharmaceuticals, Inc., Amgen.
- © 2016 by American Heart Association, Inc.