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Correspondence to Dr Amand F Schmidt, Institute of Cardiovascular Science, Faculty of Population Health Sciences, University College London, London WC1E 6BT, UK; [email protected]

Introduction

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.

Methods

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 5 trials and ezetimibe only in 2 trials. When not used as a randomised comparison treatment, statins or ezetimibe were often prescribed (ie, not randomly allocated) as background medication.Box 1

Synopsis of the collected randomised controlled trial (RCT) data on PCSK9 inhibitors

  • No. of studies overall: 20

  • No. of RCTs: 20

  • Study years: 2011–2017

  • No. of patients: 68...

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