Authors |
Truong QA,
Murphy SA, McCabe CH, Armani A, Cannon CP; on behalf of the TIMI
Study Group.
|
Abstract
|
Background- Despite the known benefit of intensive statin therapy
for reducing future cardiovascular events, its effectiveness in
women has been questioned by some. Methods and Results- In the
Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis
in Myocardial Infarction 22 (PROVE IT-TIMI 22) trial, 911 (21.9%)
women and 3251 (78.1%) men were randomized to intensive statin
(atorvastatin 80 mg) versus standard therapy (pravastatin 40 mg)
therapy for a median duration of 2.1 years. The primary end point
was death, myocardial infarction, unstable angina; revascularization
(occurring after 30 days); or stroke. Safety end points included
elevations in liver function tests, creatine kinase, and myalgias/myositis.
Women had a reduction in low-density lipoprotein (LDL) of 42.8%
from baseline at 30 days (to a median of 60 mg/dL) in the intensive
therapy arm, with 88.8% reaching the LDL goal of <100 mg/dL
and 65.0% of <70 mg/dL, compared with a 16.8% reduction in
LDL (to a median of 88 mg/dL) in the standard therapy arm. Women
receiving intensive statin therapy had a significant 25% relative
reduction over standard dose (hazard ratio, 0.75; 95% CI, 0.57
to 0.99; P=0.04) for the primary composite end point compared
with a 14% reduction for men (hazard ratio, 0.86; 95% CI, 0.75
to 0.99; P=0.04; P-interaction, 0.38). No differences were observed
between sexes for safety (all P-interaction =0.11). Conclusions-
This trial provides evidence that both women and men derived benefit
from intensive statin therapy after acute coronary syndrome, and
thus, sex should not be a factor in determining who should be
treated with intensive statin therapy. Clinical Trial Registration-
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00382460.
|