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Statin-related Muscle Toxicity: An Evidence-based Review.

ABSTRACT: The efficacy of statins in the primary and secondary prevention of cardiovascular disease has been proven beyond doubt. The number needed to treat to prevent one cardiovascular event is 1 in 30 over 10 years, and the number needed to treat for secondary prevention is much lower. However, a recent study demonstrated that only 68% of eligible patients are on statin therapy. Moreover, there seems to be a reluctance to escalate statin doses due to the fear of adverse effects. The adverse effects that worries patients and their physicians most frequently are those related to muscular symptoms. N-of-1 trial evidence suggests that muscular symptoms attributed to statins are often caused by the nocebo effect. This article aims to provide a structured, evidence-based approach to suspected statin-related muscle toxicity.

SUBMITTER: Jeeyavudeen MS

PROVIDER: S-EPMC9835810 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Statin-related Muscle Toxicity: An Evidence-based Review.

Jeeyavudeen Mohammad S MS Pappachan Joseph M JM Arunagirinathan Ganesan G

TouchREVIEWS in endocrinology 20221121 2

The efficacy of statins in the primary and secondary prevention of cardiovascular disease has been proven beyond doubt. The number needed to treat to prevent one cardiovascular event is 1 in 30 over 10 years, and the number needed to treat for secondary prevention is much lower. However, a recent study demonstrated that only 68% of eligible patients are on statin therapy. Moreover, there seems to be a reluctance to escalate statin doses due to the fear of adverse effects. The adverse effects tha ...[more]

PMID: 36694885

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Project description:IntroductionStatin-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 analysisWe 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 disseminationAs 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 numberCRD42020202619.

Project description:To estimate the incidence of muscle toxicity in patients receiving statin therapy by examining study populations, drug exposure status and outcome definitions.A retrospective cohort study.16 medical facilities in Japan providing information on laboratory tests performed in and claims received by their facilities between 1 April 2004 and 31 December 2010.A database representing a cohort of 35 903 adult statin (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin) users was studied. Use of interacting drugs (fibrates, triazoles, macrolides, amiodarone and ciclosporin) by these patients was determined.Statin-associated muscle toxicity (the 'event') was identified based on a diagnosis of muscle-related disorders (myopathy or rhabdomyolysis) and/or abnormal elevation of creatine kinase (CK) concentrations. Events were excluded if the patients had CK elevation-related conditions other than muscle toxicity. Incidence rates for muscle toxicity were determined per 1000 person-years, with 95% CI determined by Poisson regression.A total of 18 036 patients accounted for 42 193 person-years of statin therapy, and 43 events were identified. The incidence of muscle toxicity in the patients treated with statins was 1.02 (95% CI 0.76 to 1.37)/1000 person-years. The estimates varied when outcome definitions were modified from 0.09/1000 person-years, which met both diagnosis and CK 10× greater than the upper limit of normal range (ULN) criteria, to 2.06/1000 person-years, which met diagnosis or CK 5× ULN criterion. The incidence of muscle toxicity was also influenced by the statin therapies selected, but no significant differences were observed. Among 2430 patients (13.5%) received interacting drugs with statins, only three muscle toxicity cases were observed (incidence: 1.69/1000 person-years).This database study suggested that statin use is generally well tolerated and safe; however, the risk of muscle toxicity related to the use of interacting drugs requires further exploration.

Dataset Information

Statin-related Muscle Toxicity: An Evidence-based Review.

Publications

Statin-related Muscle Toxicity: An Evidence-based Review.

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