Abstract 17862: Benefit and Safety of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes in 4416 Women in the IMPROVE-IT Trial
Background: Statin therapy is established in primary and secondary prevention guidelines both for men and women, although some people have questioned the benefits in women, where data are more limited. Adding the non-statin ezetimibe to statin therapy further reduced future CV events post ACS in IMPROVE-IT, but detailed analyses by sex have not been reported.
Methods: In the IMPROVE-IT trial, patients hospitalized with ACS and LDL-C ≤125 mg/dL were randomized to ezetimibe/simvastatin 40mg (E/S) or placebo/simvastatin 40mg (P/S) and were followed up for a median of 6 yrs. The primary composite endpoint was CVD, MI, hospitalization for UA, coronary revascularization >30 days, and stroke. Efficacy and safety outcomes in women vs men were compared, one of 23 pre-specified subgroups.
Results: Among 18144 patients from IMPROVE-IT, 4416 (24%) were women. Compared with men, women were more likely to be older, diabetic, and hypertensive, but less likely to have prior revascularization or multiple vessel disease. At 12 months, the median difference in LDL-C in both women and men was 16 mg/dl between E/S and P/S. Women receiving E/S had a 12% RRR of the primary endpoint (HR vs P/S, 0.88; 95% CI, 0.79 to 0.99), compared with a 5% reduction for men (HR vs P/S; 0.95, 95% CI, 0.90 to 1.01; p interaction p=0.26). There were no differences between E/S and P/S in this or safety events (E/S vs. P/S; AST and/or ALT>3ULN, 2.5% vs. 2.6%, 2.5% vs. 2.2%, cholecystectomy, 1.8% vs. 1.6%, 1.4% vs. 1.4%, myopathy, 0.2% vs. 0.2%, 0.1% vs. 0.1%, gallbladder-related AEs, 3.9% vs. 4.3%, 2.9% vs. 3.3%, in women and in men, respectively, p=all NS).
Conclusion: IMPROVE-IT demonstrated that adding ezetimibe to statin reduces LDL-C and CV events in both women and men. A safety profile of ezetimibe supports the use of intensive, combination lipid lowering therapy to optimize CV outcomes in women as well as men.
Author Disclosures: E. Toda Kato: None. R.P. Giugliano: Honoraria; Modest; Merck. Consultant/Advisory Board; Modest; Amgen, GlaxoSmithKline, Merck, Portola, American College of Cardiology, CVS Caremark. Other; Modest; St Jude Medical. Research Grant; Significant; Amgen, Merck. Other; Significant; Lexicon. M.A. Blazing: Consultant/Advisory Board; Modest; AstraZeneca, Pfizer, Merck&Co., Inc, Pfizer, Regeneron, Sanofi. Research Grant; Significant; sanofi, Merck & Co. Honoraria; Significant; Merck&Co. Consultant/Advisory Board; Significant; Merck & Co. E. Bohula May: Consultant/Advisory Board; Modest; Merck. S. Guneri: None. J.A. White: None. J. Park: None. A. Tershakovec: Employment; Significant; Merck, Sharp & Dohme. T. Musliner: Employment; Significant; Merck & Co., Inc. E. Braunwald: Research Grant; Significant; Bristol-Myers Squibb, Duke University, AstraZeneca, Johnson&Johnson, Sanofi Aventis, Daiichi Sankyo, GlaxoSmithKline. Consultant/Advisory Board; Modest; Novartis, Sanofi Aventis, The Medicines Company, Menarini International, Bayer, Medscape, Daiichi- Sankyo. C.P. Cannon: Research Grant; Significant; Accumentrics, Arisaph, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen, Merck&Co., Inc., Takeda. Consultant/Advisory Board; Modest; Boehringer Ingelheim, GlaxoSmithKline, Merck&Co., Inc, Takeda, Bristol-Myers Squibb, CSL Behring, Essentialis, Kowa, Lipimedix, Pfizer, Regeneron, Sanofi.
- © 2015 by American Heart Association, Inc.