Background-
—
In statin trials, men and women derived similar relative risk reductions in cardiovascular events per 39 mg/dL low-
density lipoprotein cholesterol (LDL-C) reduction. We explored whether lower LDL-C levels and greater LDL-C percentage
reductions than those achieved with statins are associated with reduced major adverse cardiovascular event (MACE) rates in
women as well as men.
Methods and Results-
—
Data pooled from 10 phase 3 ODYSSEY randomized trials (n
=
4983) comparing alirocumab with control
(placebo/ezetimibe) were assessed for association between 39 mg/dL lower on-treatment LDL-C and percentage LDL-C change
from baseline, and MACE risk by sex, using multivariable Cox regression. Mean baseline LDL-C was 135 mg/dL (women) and
121 mg/dL (men). Average on-treatment LDL-C levels with alirocumab, ezetimibe, and placebo were 71, 114, and 134 mg/dL,
respectively, in women (n
=
1882) and 52, 93, and 122 mg/dL, respectively, in men (n
=
3090). Overall, 36.5% and 58.7% of women
and men, respectively, achieved on-treatment LDL-C
<
50 mg/dL. Each 39 mg/dL lower LDL-C was associated with a 33% and
22% lower risk of MACE in women (
P
=
0.0209) and men (
P
=
0.0307), respectively, with no signi
fi
cant between-sex difference
(
P
for heterogeneity
=
0.4597). Results were similar when analyzed per 50% LDL-C reduction, 24% (
P
=
0.1094) and 29% (
P
=
0.0125)
lower MACE risk in women and men, respectively (
P
for heterogeneity
=
0.7499). Alirocumab was generally well tolerated in both
sexes.
Conclusions-
—
The present analysis reinforces the notion that both sexes derive a similar cardiovascular bene
fi
t from LDL-C
lowering. Although women had slightly higher on-treatment LDL-C than men, both sexes showed a similar lower MACE risk with
lower LDL-C.