PMID- 28963307
OWN - NLM
STAT- MEDLINE
DCOM- 20180608
LR  - 20220330
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 7
IP  - 9
DP  - 2017 Sep 27
TI  - 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.
PG  - e017587
LID - 10.1136/bmjopen-2017-017587 [doi]
LID - e017587
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.
CI  - (c) 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.
FAU - Zhou, Zhen
AU  - Zhou Z
AUID- ORCID: 0000-0002-0835-8686
AD  - Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, 
      Australia.
AD  - Anhui Medical University, Hefei, Anhui, China.
FAU - Albarqouni, Loai
AU  - Albarqouni L
AD  - Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, 
      Australia.
FAU - Breslin, Monique
AU  - Breslin M
AD  - Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, 
      Australia.
FAU - Curtis, Andrea J
AU  - Curtis AJ
AD  - Department of Epidemiology and Preventive Medicine, School of Public Health and 
      Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
FAU - Nelson, Mark
AU  - Nelson M
AD  - Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, 
      Australia.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20170927
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
SB  - IM
MH  - Aged
MH  - Cardiovascular Diseases/*prevention & control
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects/therapeutic use
MH  - Muscle, Skeletal/*drug effects/*physiopathology
MH  - Primary Prevention/methods
MH  - Research Design
MH  - Systematic Reviews as Topic
PMC - PMC5623566
OTO - NOTNLM
OT  - adverse events
OT  - geriatric medicine
OT  - lipid disorders
OT  - musculoskeletal disorders
COIS- Competing interests: None declared.
EDAT- 2017/10/01 06:00
MHDA- 2018/06/09 06:00
PMCR- 2017/09/27
CRDT- 2017/10/01 06:00
PHST- 2017/10/01 06:00 [entrez]
PHST- 2017/10/01 06:00 [pubmed]
PHST- 2018/06/09 06:00 [medline]
PHST- 2017/09/27 00:00 [pmc-release]
AID - bmjopen-2017-017587 [pii]
AID - 10.1136/bmjopen-2017-017587 [doi]
PST - epublish
SO  - BMJ Open. 2017 Sep 27;7(9):e017587. doi: 10.1136/bmjopen-2017-017587.