Effects of Simvastatin 40 Mg Daily on Muscle and Liver Adverse Effects in a 5-year Randomized Placebo-controlled Trial in 20,536 High-risk People

Overview

Journal BMC Clin Pharmacol

Publisher Biomed Central

Specialty Pharmacology

Date 2009 May 16

PMID 19442259

Citations 19

Authors

Jane Armitage

Louise Bowman

Rory Collins

Sarah Parish

Jonathan Tobert

Affiliations

Soon will be listed here.

Abstract

Background: Simvastatin reduces cardiovascular mortality and morbidity but, as with other HMG-CoA reductase inhibitors, can cause significant muscle toxicity and has been associated with elevations of liver transaminases.

Methods: Muscle and liver adverse effects of simvastatin 40 mg daily were evaluated in a randomized placebo-controlled trial involving 20,536 UK patients with vascular disease or diabetes (in which a substantial reduction of cardiovascular mortality and morbidity has previously been demonstrated).

Results: The excess incidence of myopathy in the simvastatin group was < 0.1% over the 5 years of the trial, and there were no significant differences between the treatment groups in the incidence of serious hepatobiliary disease.

Conclusion: Among the many different types of high-risk patient studied (including women, older individuals and those with low cholesterol levels), there was a very low incidence (< 0.1%) of myopathy during 5 years treatment with simvastatin 40 mg daily. The risk of hepatitis, if any, was undetectable even in this very large long-term trial. Routine monitoring of liver function tests during treatment with simvastatin 40 mg is not useful.

Citing Articles

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The Safety and Tolerability of Statin Therapy in Primary Prevention in Older Adults: A Systematic Review and Meta-analysis.

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