Systematic review and meta‐analysis of clinically relevant adverse events from HMG CoA reductase inhibitor trials worldwide from 1982 to present

McClure, David L.; Valuck, Robert J.; Glanz, Morton; Hokanson, John E.

doi:10.1002/pds.1341

Cited by 49 publications

(32 citation statements)

References 137 publications

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“…Statin toxicity became of general public interest in 2001, when cerivastatin was withdrawn from the market (52 deaths from rhabdomyolysis) although rhabdomyolysis was not observed in a meta-analysis of cerivastatin clinical trials [15,16]. Such side effects can impair the quality of life, adherence to treatment, and in extreme cases, may lead to death.…”

Section: Statin-related Adverse Effectsmentioning

confidence: 99%

Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel

Banach

Rizzo²,

Tóth

et al. 2015

Expert Opinion on Drug Safety

181

204

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Section: Statin-related Adverse Effectsmentioning

confidence: 99%

Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel

Banach

Rizzo²,

Tóth

et al. 2015

Expert Opinion on Drug Safety

181

204

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“…36 There has not been much difference in muscle symptomatology reported between subjects and controls in large RCTs. 37,38 There may be a tendency to attribute background muscular symptoms to the medication, be it active statin or placebo. This so-called nocebo effect 39 attributes harm to the inactive intervention.…”

Section: Impact Of Statin Myopathy In Exercising Adultsmentioning

confidence: 99%

Statin Therapy as Primary Prevention in Exercising Adults: Best Evidence for Avoiding Myalgia

Bosomworth

2016

The Journal of the American Board of Family Medicine

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Introduction: This review aims to determine whether active adults who begin statins and develop myalgia reduce or stop activity to become less symptomatic. If this occurs, strategies to mitigate symptoms are explored. Should these strategies fail, the question of whether exercise is an adequate alternative to statin therapy is addressed.Methods: PubMed, Google Scholar, and the Cochrane Database were searched with keywords designed to retrieve information on statin myopathy in exercising adults.Results: Statins are well tolerated by most people who exercise; however, caution is warranted in those who exercise at high levels, in the elderly, and in those receiving high-dose therapy. Several strategies improve statin tolerance while maintaining exercise levels, based on low-quality evidence.

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“…In randomized clinical trials there has been no excess of muscle problems, but placebo-controlled trials have shown 2.5-fold increased risk of myositis defined by 10-fold elevation of CK [22]. The occurrence of myalgia is common complaint in statin-users [21] and can occur without CKelevations [23].…”

Section: Discussionmentioning

confidence: 99%

Discontinuation of Statin Treatment in Relation to Chronic Diseases and Laboratory Findings

Niskanen¹,

Suvisaari²,

Suvisaari³

et al. 2013

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Purpose: The aim was to study discontinuation of statin treatment, especially with respect to clinical characteristics and adverse effect measured by clinical laboratory tests indicating muscle damage (plasma creatine kinase, CK) and liver AEs (plasma alanine aminotransferase, ALAT). Methods: The initial study population included 60,488 individuals who had purchased first time statin prescription in Helsinki-Uusimaa region between 01-01-2007 and 31-12-2009. The follow-up started when first statin prescription was purchased and ended 31-12-2009 or death, which ever occurred first. From this population 54,172 individuals were defined to eligible to study population of this study. Clinical laboratory measurements were obtained from Helsinki-Uusimaa University Hospital (HUSLAB) that which provides the laboratory tests for the Helsinki-Uusimaa region serving about a population of 1.5 million. Results: In this fairly large real-life study the occurrence of ALAT-AE and mild CK-elevations after initiation of first statin treatments were relatively low. Increasing age and the presence of co-morbidities increased the risk of these AEs. Further, the ALAT-AEs implied increased risk of discontinuation of treatment. Diabetic patients discontinued treatment more often than nondiabetics, whereas the presence of other chronic conditions implied higher persistence of statin treatment. Conclusions: It is essential that those who would benefit from statin therapy actually are treated and by far in most patients treatment seems to be safe and well tolerated. For those who cannot tolerate statins new therapeutic options are needed.

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Systematic review and meta‐analysis of clinically relevant adverse events from HMG CoA reductase inhibitor trials worldwide from 1982 to present

Abstract: Overall, discontinuation of statin therapy due to adverse events was no worse than placebo. The risks of muscle-related adverse events were in general agreement with the known risks of statins.

Cited by 49 publications

References 137 publications

Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel

Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel

Statin Therapy as Primary Prevention in Exercising Adults: Best Evidence for Avoiding Myalgia

Discontinuation of Statin Treatment in Relation to Chronic Diseases and Laboratory Findings

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