Cardiovascular events with pcsk9 inhibitors: an updated meta-analysis of randomised controlled trials

Publication date: Available online 26 March 2019Source: Pharmacological ResearchAuthor(s): Manuela Casula, Elena Olmastroni, Mezio T. Boccalari, Elena Tragni, Angela Pirillo, Alberico L. CatapanoAbstractThe therapy with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors efficiently reduces plasma cholesterol levels, which has been recently associated with improvement in cardiovascular outcomes. This meta-analysis aimed at investigating the safety and efficacy of treatment with the clinically available anti-PCSK9 monoclonal antibodies (mAbs) in all published randomized clinical trials (RCTs), updating the available results with the recently published ODYSSEY OUTCOMES trial.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 (specifically 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 DerSimonian & Laird method (random-effects model). Between-study heterogeneity was tested by Cochrane’s Q test and measured with the I2 statistics.Twenty-eight RCTs comprising 62,281 participants (33,204 in the mAb arm, 29,077 in the placebo arm) were included in the meta-analysis. The treatment follow-up ranged from 8 weeks up to 208 weeks. Overall, no significant difference in all-...
Source: Pharmacological Research - Category: Drugs & Pharmacology Source Type: research