Tolerability of statin-based management of patients with a history of statin-associated muscle symptoms: protocol for a systematic review.

Villoz, Fanny; Lyko, Christina; Del Giovane, Cinzia; Rodondi, Nicolas; Blum, Manuel R (2021). Tolerability of statin-based management of patients with a history of statin-associated muscle symptoms: protocol for a systematic review. BMJ open, 11(8), e052341. BMJ Publishing Group 10.1136/bmjopen-2021-052341

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INTRODUCTION

Statin-associated muscle symptoms (SAMSs) are a major clinical issue in the primary and secondary prevention of cardiovascular events. Current guidelines advise various approaches mainly based on expert opinion. We will lead a systematic review and meta-analysis to explore the tolerability and acceptability and effectiveness of statin-based therapy management of patients with a history of SAMS. We aim to provide evidence on the tolerability and different strategies of statin-based management of patients with a history of SAMS.

METHODS AND ANALYSIS

We will conduct a systematic review of randomised controlled trials (RCTs) and non-randomised studies with a control group. We will search in Data sources MEDLINE, EMBASE, Cochrane Central Register of Controlled Clinical Trials, Scopus, Clinicaltrials.gov and Proquest from inception until April 2021. Two independent reviewers will carry out the study selection based on eligibility criteria. We will extract data following a standard data collection form. The reviewers will use the Cochrane Collaboration's tools and Newcastle-Ottawa Scale to appraise the study risk of bias. Our primary outcome will be tolerability and our secondary outcomes will be acceptability and effectiveness. We will conduct a qualitative analysis of all included studies. In addition, if sufficient and homogeneous data are available, we will conduct quantitative analysis. We will synthesise dichotomous data using OR with 95% CI and continuous outcomes by using mean difference or standardised mean difference (with 95% CI). We will determine heterogeneity visually with forest plots and quantitatively with I2 and Q-test. We will summarise the confidence in the quantitative estimate by using Grading of Recommendations Assessment, Development and Evaluation approach.

ETHICS AND DISSEMINATION

As a systematic review of literature without collection of new clinical data, there will be no requirement for ethical approval. We will disseminate findings through peer-reviewed publications.

PROSPERO REGISTRATION NUMBER

CRD42020202619.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine

UniBE Contributor:

Villoz, Fanny; Lyko, Christina Valérie; Del Giovane, Cinzia; Rodondi, Nicolas and Blum, Manuel

Subjects:

300 Social sciences, sociology & anthropology > 360 Social problems & social services
600 Technology > 610 Medicine & health

ISSN:

2044-6055

Publisher:

BMJ Publishing Group

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

13 Aug 2021 17:04

Last Modified:

13 Aug 2021 18:05

Publisher DOI:

10.1136/bmjopen-2021-052341

PubMed ID:

34344686

Uncontrolled Keywords:

adverse events cardiology general medicine (see internal medicine) lipid disorders preventive medicine primary care

BORIS DOI:

10.48350/158009

URI:

https://boris.unibe.ch/id/eprint/158009

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