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Despite the availability of effective drug therapies reducing LDL-cholesterol (LDL-C), cardiovascular disease (CVD) remains a significant source of mortality and morbidity. Additional LDL-C reduction may be warranted, especially in patients that are unresponsive to or unable to take existing LDL-C reducing therapies.1 Monoclonal antibodies against PCSK9 (PCSK9 inhibitors) may provide such additional LDL-C reduction. In this synopsis, we summarise findings from a recent Cochrane systematic review2 on the safety and effectiveness of PCSK9 inhibitors. Here we particularly focus on the relative effectiveness of PCSK9 inhibitors compared to existing treatments such as statins and/or ezetimibe and report on the (perceived) quality of the evidence.
The following databases were systematically searched for eligible randomised controlled trials (RCTs): Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, Clinicaltrials.gov and the International Clinical Trials Registry Platform. Parallel-group and factorial RCTs with at least 24 weeks of follow-up were included.
Summary of findings
The 20 identified randomised trials (68 341 participants) predominantly selected high-risk patients (box 1): 7% having familial hypercholesterolaemia, 89% a history of CVD and 39% a type 2 diabetes mellitus (T2DM) diagnosis. The PCSK9 inhibitor alirocumab was evaluated in 13 trials, evolocumab in 3 trials, bococizumab (discontinued agent) in 3 trials and RG7652 by a single trial. Comparisons were made against placebo in 13 trials, ezetimibe and statins in …
Contributors All authors contributed to the idea, design and analyses of the study and drafted the manuscript. AFS had full access to all of the data and takes responsibility for the integrity of the data presented.
Funding AFS is funded by UCLH NIHR Biomedical Research Centre and is a UCL Springboard Population Health Sciences Fellow. ADH is an NIHR Senior Investigator and is funded by the UCL Hospitals NIHR Biomedical Research Centre.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data are available at: http://www.cochrane.org/CD011748/VASC_pcsk9-inhibitors-prevention-cardiovascular-disease.
Collaborators John Overington.
Presented at This study and its results were presented at the 2016 Cochrane colloquium in Seoul, South Korea and are published as a Cochrane systematic review and meta-analysis.