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

Zhen Zhou, Loai Albarqouni, Monique Breslin, Andrea J Curtis, Mark Nelson

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1 Citation (Scopus)
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Abstract

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.

TRIAL REGISTRATION NUMBER: CRD42017058436.

Original languageEnglish
Article numbere017587
Pages (from-to)1-9
Number of pages10
JournalBMJ Open
Volume7
Issue number9
DOIs
Publication statusPublished - 27 Sep 2017

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Primary Prevention
Meta-Analysis
Cardiovascular Diseases
Randomized Controlled Trials
Muscles
Rhabdomyolysis
Muscular Diseases
Creatine Kinase
Ethics
Publications
Language
Placebos
Databases

Cite this

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title = "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",
abstract = "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.TRIAL REGISTRATION NUMBER: CRD42017058436.",
author = "Zhen Zhou and Loai Albarqouni and Monique Breslin and Curtis, {Andrea J} and Mark Nelson",
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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, Zhen; Albarqouni, Loai; Breslin, Monique; Curtis, Andrea J; Nelson, Mark.

In: BMJ Open, Vol. 7, No. 9, e017587, 27.09.2017, p. 1-9.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Statin-associated muscle symptoms (SAMS) in primary prevention for cardiovascular disease in older adults

T2 - A protocol for a systematic review and meta-analysis of randomised controlled trials

AU - Zhou, Zhen

AU - Albarqouni, Loai

AU - Breslin, Monique

AU - Curtis, Andrea J

AU - Nelson, Mark

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2017/9/27

Y1 - 2017/9/27

N2 - 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.TRIAL REGISTRATION NUMBER: CRD42017058436.

AB - 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.TRIAL REGISTRATION NUMBER: CRD42017058436.

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