The aim of this study was to evaluate the effect of atorvastatin on lipid lowering,
cardiovascular (CV) events, and adverse events in women compared with men in 6 clinical
trials. In the Incremental Decrease in End Points Through Aggressive Lipid Lowering
(IDEAL) trial (atorvastatin 80 mg vs simvastatin 20 to 40 mg), the Treating to New
Targets (TNT) trial (atorvastatin 80 vs 10 mg), the Stroke Prevention by Aggressive
Reduction in Cholesterol Levels (SPARCL) trial (atorvastatin 80 mg vs placebo), and
the Collaborative Atorvastatin Diabetes Study (CARDS), the Anglo-Scandinavian Cardiac
Outcomes Trial (ASCOT), and the Atorvastatin Study for Prevention of Coronary Heart
Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN) (atorvastatin
10 mg vs placebo), lipid changes on treatment were compared between genders with studies
grouped by dose. The association of on-study low-density lipoprotein (LDL) cholesterol
and CV events by gender was evaluated in the combined studies and the impact of gender
on adverse events in each study separately. Major CV events occurred in 3,083 of 30,000
men (10.3%) and 823 of 9,173 women (9.0%). Changes in lipids were similar in women
and men. Major CV events were associated with gender-specific quintiles of on-treatment
LDL cholesterol for women and men. In women, LDL cholesterol was a significant predictor
of stroke, but not in men. Discontinuation rates due to adverse events were higher
in women in 4 of 6 trials, but in only 1 trial was a significant treatment-gender
interaction seen. Myalgia rates were slightly higher in women in both statin and placebo
groups. In conclusion, the response of women to atorvastatin was similar to that of
men, with slightly more discontinuations due to adverse events. Higher on-treatment
LDL cholesterol was significantly associated with more CV events in both genders,
but the association was stronger for stroke in women and for coronary heart disease
death in men.
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Article Info
Publication History
Published online: November 29, 2014
Accepted:
November 12,
2014
Received in revised form:
November 12,
2014
Received:
October 15,
2014
Footnotes
See page 452 for disclosure information.
Identification
Copyright
© 2015 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
