ODYSSEY Alirocumab trials: lower major adverse cardiovascular events risk with lower LDL cholesterol levels
In statin trials, men and women have shown similar relative risk reductions in cardiovascular events per 39 mg/dL low-density lipoprotein cholesterol ( LDL-C ) reduction.
Researchers have assessed 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.
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 cholesterol 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 less than 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 significant 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.
In conclusion, the present analysis reinforces the notion that both sexes derive a similar cardiovascular benefit 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 cholesterol. ( Xagena )
Vallejo-Vaz AJ et al, J Am Heart Assoc 2018;7(18):e009221. doi: 10.1161/JAHA.118.009221
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