Zhou Zhen, Albarqouni Loai, Breslin Monique, Curtis Andrea J, Nelson Mark
Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.
Anhui Medical University, Hefei, Anhui, China.
BMJ Open. 2017 Sep 27;7(9):e017587. doi: 10.1136/bmjopen-2017-017587.
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.
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.
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.
CRD42017058436.
尽管他汀类药物常用于预防心血管疾病，但关于老年人使用他汀类药物相关不良反应的证据有限。他汀类药物相关不良事件（AE），尤其是他汀类药物相关肌肉症状（SAMS），是导致停药的最常见原因。因此，确定老年人群中SAMS的风险很重要。我们将进行一项系统评价和荟萃分析，主要关注SAMS的风险，其次针对肌病、横纹肌溶解症、AE和严重AE、在导入期因SAMS导致的退出、他汀类药物相关的永久停药率以及肌酸激酶水平，研究对象为接受他汀类药物进行一级预防的老年人。
本研究是根据系统评价和荟萃分析方案的首选报告项目声明开展的。我们将纳入他汀类药物与安慰剂对比的随机对照试验，研究对象为年龄≥65岁的老年人，随访时间至少1年。本评价是对一项Cochrane系统评价的更新，该系统评价纳入了2012年之前发表的文章。将检索Cochrane对照试验中心注册库、Medline OvidSP和Embase电子数据库以识别相关文章，将发表日期限制在2012年1月1日至2017年2月13日。不设语言限制。两名独立的评审员将对标题、摘要和全文进行重复筛选。将分别使用Cochrane协作网工具和推荐分级评估、制定与评价方法评估偏倚风险和证据质量。如果合适，将使用汇总数据进行荟萃分析。我们还将进行meta回归和亚组分析以识别异质性来源。
由于使用的是匿名汇总数据，本研究无需伦理批准。研究结果将在会议上报告并发表在同行评审期刊上。
CRD42017058436。
