Abstract
BackgroundGuideline-recommended low-density lipoprotein cholesterol (LDL-C) thresholds are often not achieved in women. The proprotein convertase subtilisin/kexin type-9 inhibitor (PCSK9i) monoclonal antibodies can help further reduce LDL-C and major adverse cardiovascular events (MACE) although differences in efficacy by sex and type are less understood. ObjectivesThe authors sought to determine if there are differences in the efficacy of LDL-C lowering and reduction in the risk of MACE by sex and type of PCSK9i. MethodsA comprehensive literature search was done through October 17, 2022, for published trials comparing PCSK9i vs control. Outcomes assessed were LDL-C reduction and incidence of MACE following the use of PCSK9i vs placebo, stratified by sex and type of PCSK9i used. ResultsWe identified 16 trials with 54,996 adults, and 15,143 (27.5%) of them were female. PCSK9i significantly reduced MACE compared to placebo in both women (HR: 0.86, 95% CI: 0.74-0.97, P < 0.001) and men (HR: 0.85, 95% CI: 0.79-0.91, P < 0.001) with no significant sex difference (MD −0.01, 95% CI: −0.14 to −0.13, P = 0.930). PCSK9i also significantly reduced LDL-C levels in both sexes at 12 weeks (females: MD −62.57, 95% CI: −70.24 to −54.91, P < 0.001; males: MD −66.19, 95% CI: −72.03 to −60.34, P < 0.001) and 24 weeks (females: MD −47.52, 95% CI: −52.94 to −42.09, P < 0.001; males: MD −54.07, 95% CI: −59.46 to −48.68, P < 0.001). Significant sex difference was seen in the LDL reduction of PCSK9i for both 12 weeks (males vs females: MD −4.55, 95% CI: −7.34 to −1.75, P < 0.01) and 24 weeks (males vs females: MD −7.11, 95% CI: −9.99 to −4.23, P < 0.001). ConclusionsThe use of PCSK9i results in significant LDL-C and MACE reduction in both males and females. While there is no significant sex difference in MACE reduction, LDL-C reduction is greater in males than in females. Our data support the equal use of PCSK9i in all eligible patients, regardless of sex.
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