Abstract 16974: Comparison of Low-density Lipoprotein Cholesterol Threshold Attainment With Alirocumab versus Ezetimibe Treatment in the ODYSSEY Program
Introduction: Recent guidelines and treatment pathways recommend PCSK9 inhibitors (e.g., alirocumab [ALI]) or ezetimibe (EZE) on background statin therapy for patients not reaching LDL-C thresholds despite treatment with maximally-tolerated statin (MTS) doses ± other lipid-lowering therapies. This analysis compares LDL-C threshold attainment with ALI 75/150 mg Q2W vs EZE 10 mg treatment following moderate to MTS dose therapy in a pool of 3 randomized, EZE-controlled Phase III ODYSSEY studies (COMBO II, OPTIONS I, OPTIONS II).
Methods: Patients were randomized to ALI or EZE in a double-blind fashion. Patients were stratified based on their calculated baseline LDL-C levels, and the percent of patients reaching an LDL-C threshold of <70 mg/dL at week (W)12 and W24 was assessed.
Results: A higher percent of patients achieved the LDL-C threshold of <70 mg/dL on ALI treatment than on EZE, regardless of baseline LDL-C level (Figure). The difference between ALI and EZE in percent of patients reaching this LDL-C threshold became particularly apparent at baseline LDL-C levels >100 mg/dL, and no patients with very high LDL-C levels of >190 mg/dL on EZE reached the threshold. The rate of TEAEs was comparable between groups (75.4% ALI vs 71.6% EZE; P>0.05). The most commonly reported TEAEs in ALI-treated patients included upper respiratory tract infection, accidental overdose, and hypertension.
Conclusions: ALI treatment allowed more patients to reach the LDL-C threshold level of <70 mg/dL than EZE treatment. ALI treatment was particularly beneficial for patients with high baseline LDL-C levels of >130 mg/dL, for whom reaching the LDL-C level of <70 mg/dL was rare on EZE. These results support a consistent benefit of alirocumab over ezetimibe as add-on treatment to background statin therapy especially for patients with high baseline LDL-C levels of >130 mg/dL, which could help guide current treatment pathways and guideline recommendations.
Author Disclosures: C.P. Cannon: Research Grant; Significant; Arisaph, AstraZeneca, Bristol-Myers Squibb, Boehringer-Ingelheim, GlaxoSmithKline, Janssen, Merck, Takeda. Consultant/Advisory Board; Modest; Alnylam, Amgen, Arisaph, Boehringer-Ingelheim, Boehringer-Ingelheim/Lilly, Bristol-Myers Squibb, Kowa, Merck, Takeda, Pfizer. Consultant/Advisory Board; Significant; Lipimedix, Regeneron Pharmaceuticals, Inc., Sanofi, GlaxoSmithKline. B. Cariou: Research Grant; Modest; Pfizer, Sanofi. Honoraria; Modest; Amgen, Sanofi, Regeneron Pharmaceuticals, Inc., Merck. Consultant/Advisory Board; Modest; Amgen, Sanofi, Regeneron Pharmaceuticals, Inc., Merck. V. Valcheva: Employment; Significant; Sanofi. S. Guillonneau: Employment; Significant; Sanofi. S.R. Iorga: Employment; Significant; Regeneron Pharmaceuticals, Inc. M.H. Davidson: Speakers Bureau; Significant; Amgen, Regeneron Pharmaceuticals, Inc., Sanofi. Honoraria; Significant; Amgen, Regeneron Pharmaceuticals, Inc., Sanofi. Consultant/Advisory Board; Modest; Amgen, Regeneron Pharmaceuticals, Inc., Sanofi.
- © 2016 by American Heart Association, Inc.