Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
BMJ Open. 2021 Aug 3;11(8):e052341. doi: 10.1136/bmjopen-2021-052341.
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.
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 I and Q-test. We will summarise the confidence in the quantitative estimate by using Grading of Recommendations Assessment, Development and Evaluation approach.
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.
CRD42020202619.
他汀类药物相关肌肉症状（SAMS）是心血管事件一级和二级预防中的一个主要临床问题。目前的指南建议主要基于专家意见采取各种方法。我们将进行系统评价和荟萃分析，以探讨有 SAMS 病史患者的他汀类药物治疗管理的耐受性和可接受性及有效性。我们旨在提供有关有 SAMS 病史患者的他汀类药物管理的耐受性和不同策略的证据。
我们将对随机对照试验（RCT）和有对照组的非随机研究进行系统评价。我们将从建库开始至 2021 年 4 月在数据来源 MEDLINE、EMBASE、Cochrane 中央对照临床试验注册库、Scopus、Clinicaltrials.gov 和 Proquest 中进行检索。两名独立审查员将根据纳入标准进行研究选择。我们将按照标准数据收集表提取数据。审查员将使用 Cochrane 协作工具和 Newcastle-Ottawa 量表评估研究的偏倚风险。我们的主要结局将是耐受性，次要结局将是可接受性和有效性。我们将对所有纳入的研究进行定性分析。此外，如果有足够且同质的数据，我们将进行定量分析。我们将使用 OR 及其 95%CI 对二分类数据进行合并，使用均数差或标准化均数差（及其 95%CI）对连续性数据进行合并。我们将通过森林图直观地确定异质性，并通过 I ²和 Q 检验定量地确定异质性。我们将使用推荐评估、制定与评价方法（Grading of Recommendations Assessment, Development and Evaluation approach）来确定定量估计的置信度。
由于这是一项对文献进行系统评价而不收集新的临床数据的研究，因此不需要伦理批准。我们将通过同行评议的出版物传播研究结果。
PROSPERO 注册号：CRD42020202619。
