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Statin-associated muscle symptoms (SAMS) in primary prevention for cardiovascular disease in older adults: a protocol for a systematic review and meta-analysis of randomised controlled trials


Zhou, Z and Albarqouni, L and Breslin, M and Curtis, AJ and Nelson, M, Statin-associated muscle symptoms (SAMS) in primary prevention for cardiovascular disease in older adults: a protocol for a systematic review and meta-analysis of randomised controlled trials, BMJ Open, 7, (9) Article e017587. ISSN 2044-6055 (2017) [Contribution to Refereed Journal]


Copyright Statement

Copyright 2017 Article authors. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)

DOI: doi:10.1136/bmjopen-2017-017587


Introduction: Although statins are commonly used for prevention of cardiovascular disease, there is limited evidence about statin-related adverse effects in older people. Statin-related adverse events (AEs), especially the statin-associated muscle symptoms (SAMS), are the most common reasons for their discontinuation. Therefore, it is important to determine the risk of SAMS in the older population. We will undertake a systematic review and meta-analysis primarily focusing on the risk of SAMS and secondarily targeting myopathy, rhabdomyolysis, AEs and serious AEs, dropouts due to SAMS in run-in period, related permanent discontinuation rate of statins and creatine kinase level, among older people who received statins for primary prevention.

Methods and Analysis: This study has been developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols statement. We will include randomised controlled trials in which statin was compared with placebo with at least 1 year follow-up among older adults aged ≥65. This review is an update of a Cochrane systematic review that included the articles published before 2012. Cochrane Central Register of Controlled Trials, Medline OvidSP and Embase electronic database searches will be performed to identify relevant articles, limiting the publication date from 1 January 2012 to 13 February 2017. There will be no language limitation. Two independent reviewers will screen titles and abstracts and full text in duplicate. Risk of bias and evidence quality will be assessed using the Cochrane Collaboration's tool and the Grading of Recommendations Assessment, Development and Evaluation approach, respectively. A meta-analysis using pooled data will be undertaken, if appropriate. We will also perform metaregression and subgroup analyses to identify sources of heterogeneity.

Ethics and Dissemination: This study is exempt from ethics approval due to the anonymous and aggregated data used. The outcomes will be disseminated by conference presentations and published in a peer-reviewed journal.

Item Details

Item Type:Contribution to Refereed Journal
Keywords:adverse events, geriatric medicine, lipid disorders, musculoskeletal disorders
Research Division:Biomedical and Clinical Sciences
Research Group:Cardiovascular medicine and haematology
Research Field:Cardiology (incl. cardiovascular diseases)
Objective Division:Health
Objective Group:Clinical health
Objective Field:Clinical health not elsewhere classified
UTAS Author:Zhou, Z (Dr Zhen Zhou)
UTAS Author:Breslin, M (Dr Monique Breslin)
UTAS Author:Nelson, M (Professor Mark Nelson)
ID Code:124392
Year Published:2017
Web of Science® Times Cited:6
Deposited By:Menzies Institute for Medical Research
Deposited On:2018-02-21
Last Modified:2018-12-13
Downloads:137 View Download Statistics

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