Simvastatin side effects are far higher than reported in clinical trials. - GreenMedInfo Summary
Simvastatin and side effects.
N Z Med J. 1991 Nov 27 ;104(924):493-5. PMID: 1745460
Princess Margaret Hospital, Christchurch.
OBJECT: to investigate the symptomatic and biochemical side effect profile of simvastatin (a new cholesterol lowering drug) following routine use in a specialist hospital outpatient clinic.
METHODS: all patients (n = 110) newly commenced on simvastatin at the lipid disorders clinic at the Princess Margaret Hospital in the first ten months of prescription availability were asked to complete a side effects questionnaire and biochemical evaluation at six months of therapy.
RESULTS: 76.4% of patients reported experiencing no side effects with 8% of patients spontaneously reporting feeling better since commencing therapy. Nineteen point one percent of patients reported experiencing symptoms they attributed to simvastatin but had continued therapy, while a further 4.5% of patients had withdrawn from therapy because of side effects. The most frequently reported side effects were muscle ache (13.6%), and gastrointestinal symptoms (4.5%). No abnormalities in biochemical safety tests occurred.
CONCLUSIONS: the rate of side effects reported with prescription use exceeds that previously encountered in clinical trials. Since simvastatin is considered effective and well tolerated it is likely to receive wide acceptance in the management of high risk hypercholesterolaemic patients. However, this study indicates the need for continued physician awareness of the main symptoms and their frequency amongst those treated with simvastatin.