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

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. Muscle and liver adverse effects of simvastatin 40 mg daily were evaluated in a randomized...

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Bibliographic Details
Published in:BMC clinical pharmacology 2009-03, Vol.9 (1), p.6-6, Article 6
Main Authors: Armitage, Jane, Bowman, Louise, Collins, Rory, Parish, Sarah, Tobert, Jonathan
Format: Article
Language:English
Subjects:
Aged
Anticholesteremic Agents - toxicity
Cardiovascular diseases
Complications and side effects
Dosage and administration
Drug therapy
Female
Follow-Up Studies
Health aspects
Hepatitis
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - toxicity
Hypoglycemic Agents - toxicity
Incidence
Liver - drug effects
Liver - metabolism
Middle Aged
Muscle diseases
Muscles - drug effects
Muscles - metabolism
Muscular Diseases - chemically induced
Patient Compliance
Patient outcomes
Placebos
Risk Factors
Simvastatin
Simvastatin - toxicity
Treatment Outcome
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Summary: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. 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). 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. 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.
ISSN:1472-6904
1472-6904
DOI:10.1186/1472-6904-9-6