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Drug therapies targeted at the reduction of low-density lipoproteincholesterol (LDL-C) are mainstream in the treatment of cardiovascular disease (CVD) and particularly for the prevention of coronary heart disease. In patients who do not have a sufficient response to, or who do not tolerate traditional LDL-C-lowering therapies such as statins or ezetimibe, monoclonal antibodies (mAbs) against PCSK9 (PCSK9 inhibitors) may provide an alternative treatment. Non-mAb-based PCSK9 inhibitors such as inclisiran are also emerging but currently lack robust outcome data1 and their effects are not considered in the current review. In this synopsis, we summarise findings from a recent update of a Cochrane systematic review on the efficacy and safety of PCSK9 inhibitors.2 This article focuses on the effects on outcomes (CVD and total mortality), safety, and the quality of the evidence in studies of mAb PCSK9 inhibitors alirocumab and evolocumab. Most of the available studies compared PCSK9 mAb treatment against placebo (against a background of usual care including statin and or ezetimibe), with a smaller group of studies evaluating the effects of PCSK9 mAb directly against statins and/or ezetimibe (none of the trials compared PCSK9 exclusively against statin treatment).
The following databases were systematically searched for suitable randomised controlled trials (RCTs): Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Web of Science, ClinicalTrials.gov and the International Clinical …
Contributors J-PC drafted the manuscript, all coauthors provided critical input.
Funding AFS is supported by BHF grant PG/18/5033837. ADH is an NIHR Senior Investigator. Both AFS and ADH acknowledge support by the UCL BHF Research Accelerator AA/18/6/34223 award. JW reports receiving grants from the NHLBI.
Disclaimer This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2020, Issue 10, DOI: /10.1002/14651858.CD011748.pub3 (see www.cochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review.
Competing interests AFS has received Servier funding for unrelated work.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Commissioned; externally peer reviewed.
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