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May 16, 2019

87th EAS Congress

04 - SAFETY AND CARDIOVASCULAR EFFICACY OF ANTI-PCSK9 MONOCLONAL ANTIBODIES: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS

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Abstract

The inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) efficiently reduces plasma cholesterol levels. This meta-analysis aimed at investigating the efficacy on cardiovascular (CV) outcomes and the safety of treatment with anti-PCSK9 monoclonal antibodies (mAbs) in all published randomized clinical trials (RCTs). Data search was carried out using PubMed/MEDLINE and EMBASE (inception – January 2019). Inclusion criteria were: (1) phase 2 or 3 RCTs; (2) comparing anti-PCSK9 mAbs evolocumab and alirocumab with placebo; (3) with effects on outcomes reported; (4) with treatment duration longer than 8 weeks. Odds ratios (ORs) with 95% CIs were used as summary statistics. We pooled the estimates by using both the Mantel & Haenszel method (fixed-effects model). Twenty-eight RCTs comprising 62,281 participants (33,204 in the mAb arm, 29,077 in the placebo arm) were finally included in the meta-analysis. The treatment follow-up ranged from 8 weeks up to 208 weeks. Overall, no significant difference in all-cause mortality was observed between the two groups (OR 0.93 [95% CI, 0.85-1.03]). The treatment with an anti-PCSK9 mAb was associated with a significant reduction of CV events compared with placebo (OR 0.83 [95% CI, 0.78-0.87]). No significant difference was observed in cardiovascular mortality (OR 0.94 [95% CI, 0.83-1.07]). The incidence of serious adverse events was similar in the two groups (OR: 0.95, [95% CI, 0.91-0.99]). Thus, the pharmacological approach with anti-PCSK9 mAbs significantly and safely improved cardiovascular outcomes. The non-significant effect on cardiovascular mortality suggested that specific longer-term studies are warranted to address this issue.

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© Copyright 2019 Morressier GmbH.
All rights reserved.