AUTHOR=Wang Hong-Fei , Mao Yu-Cheng , Xu Xin-Yi , Zhao Si-Yu , Han Dan-Dan , Ge Shi-Yao , Song Kai , Geng Chang , Tian Qing-Bao 

TITLE=Effect of alirocumab and evolocumab on all-cause mortality and major cardiovascular events: A meta-analysis focusing on the number needed to treat

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 9 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.1016802

DOI=10.3389/fcvm.2022.1016802

ISSN=2297-055X

ABSTRACT=Aims: The efficacy of anti-proprotein convertase subtilisin/Kexin type 9 (PCSK9) monoclonal antibodies in patients with atherosclerotic cardiovascular disease (ASCVD) remains unclear. Therefore, this study aims to assess the effect of PCSK9 inhibitors (alirocumab and evolocumab) on all-cause mortality and major cardiovascular events considering the number needed to treat (NNT).
Methods: We reviewed randomized controlled trials (RCTs) which compared the effects of alirocumab or evolocumab and placebo or standards of care on all-cause mortality and major cardiovascular events. All articles were published in English up to May 2022. We estimated risk ratios (RRs), NNT, and 95% confidence intervals (CI) using random effect models.
Results: We included 12 RCTs comprising 53 486 patients of whom 27 674 were treated with PCSK9 inhibitors and 25 812 with controls. The mean follow-up duration was 1.56 years. The effect of PCSK9 inhibitors on major adverse cardiovascular events (MACE) was statistically significant, and the corresponding mean NNT was 36. Alirocumab reduced the risk of MACE, stroke, and coronary revascularization; the corresponding mean NNT were 37, 319, and 107, respectively. Evolocumab had a positive effect on MACE, myocardial infarction, stroke, and coronary revascularization; the corresponding mean NNT were 32, 78, 267, and 65, respectively. The effects of alirocumab or evolocumab on all-cause mortality and cardiovascular mortality were not statistically significant.
Conclusions: This study suggests that 36 patients with ASCVD needed to be treated with PCSK9 inhibitors for 1.56 years to prevent one patient from MACE. Both alirocumab and evolocumab reduced MACE, stroke, and coronary revascularization. Evolocumab had a positive effect on myocardial infarction, but no effects were noted for alirocumab. In addition, alirocumab may not be as effective as evolocumab. NNT visualizes the magnitude of efficacy to assist in clinical decisions.