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Safety and Tolerability of Cholesterol Lowering With Simvastatin During 5 Years in the Scandinavian Simvastatin Survival Study

Terje R. Pedersen, MD, PhD; Káre Berg, MD; Thomas J. Cook, MS; Ole Færgeman, MD; Torben Haghfelt, MD; John Kjekshus, MD; Tatu Miettinen, MD; Thomas A. Musliner, MD; Anders G. Olsson, MD; Kalevi Pyörälä, MD; Gudmundur Thorgeirsson, MD; Jonathan A. Tobert, MD, PhD; Hans Wedel, PhD; Lars Wilhelmsen, MD
Arch Intern Med. 1996;156(18):2085-2092. doi:10.1001/archinte.1996.00440170097011.
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Background:  Long-term safety is an important consideration in the selection and use of drugs, such as lipid-lowering agents, that are prescribed to reduce the risk of clinical events during long periods.

Methods:  The Scandinavian Simvastatin Survival Study was designed to evaluate the effects of cholesterol lowering with simvastatin on mortality and morbidity in patients with coronary heart disease. The 4444 patients aged 35 to 70 years (mean, 58.9 years) with angina pectoris or previous myocardial infarction and serum cholesterol levels of 5.5 to 8.0 mmol/L (213-310 mg/dL) receiving a lipid-lowering diet were randomly assigned to take double-blind treatment with simvastatin, 20 to 40 mg once daily, or placebo. In addition to previously reported end-point events, detailed clinical and laboratory safety data were collected during a median follow-up period of 5.4 years (range in survivors, 4.9-6.2 years).

Results:  The only clearly drug-related serious adverse event during the 5.4-year median follow-up period was a single reversible case of myopathy. The frequencies of persistent elevations of hepatic aminotransferase levels above 3 times the upper limit of normal and of nonviral hepatitis in the simvastatin and placebo treatment groups were not significantly different. Examination of the lens showed no between-group differences, and no previously unrecognized adverse effects of the drug were observed. There were no significant between-group differences in adverse events in any body system. In particular, the frequency of adverse events related to the central nervous system was similar in both groups.

Conclusion:  The safety profile of simvastatin, 20 to 40 mg daily, over 5 years was excellent.Arch Intern Med. 1996;156:2085-2092

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