Safety profile of rosuvastatin: results of a prescription-event monitoring study of 11,680 patients.
OBJECTIVE
Rosuvastatin is a lipid-lowering drug, the newest of a class of drugs called HMG-CoA reductase inhibitors, or 'statins', launched in the UK in March 2003. Our objective was to monitor the post-marketing safety of this drug, prescribed in primary care in England, using prescription-event monitoring.


METHODS
An observational cohort study in which patients were identified from dispensed prescriptions issued by primary care physicians/general practitioners (GPs) between August and December 2003. Demographic and clinical-event data were collected from questionnaires posted to GPs at least 6 months after the date of first prescription for each patient. Stratified analysis of specific events by starting dose of rosuvastatin was conducted. Follow-up and causality assessment of medically significant events was undertaken.


RESULTS
The cohort comprised 11,680 patients (median age 64 years); 50.3% were males (5880 of 11,680). The median period of treatment was 9.8 months. Of these patients, 72.7% (n = 8494) were started on rosuvastatin 10 mg/day. A total of 17.5% (n = 2047) of the patients were reported to have stopped treatment with rosuvastatin. Myalgia was the most frequent reason for stopping rosuvastatin and the most frequently reported clinical event. A 2.5-fold increase in the rate of abnormal liver-function tests (LFTs) was observed for patients started on rosuvastatin 40 mg/day compared with those started on 10 mg/day (2.71; 95% CI 1.53, 4.53). No case of rhabdomyolysis was reported in this cohort.


CONCLUSIONS
Rosuvastatin was considered to be a reasonably well tolerated drug. In the majority of patients, rosuvastatin was prescribed in line with recommendations. Abnormality of LFTs was found to be more frequent with the 40 mg/day dosage of rosuvastatin. Results from this study should be taken into account together with those of other clinical and pharmacoepidemiological studies of rosuvastatin.
Kasliwal
Rachna
R
Drug Safety Research Unit, Southampton, UK. rachna.kasliwal@dsru.org
Wilton
Lynda V
LV
Cornelius
Victoria
V
Aurich-Barrera
Beate
B
Shakir
Saad A W
SA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D056486:Chemical and Drug Induced Liver Injury; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D011307:Drug Prescriptions; D004739:England; D005194:Family Practice / Q000706:statistics & numerical data*; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D007674:Kidney Diseases / Q000139:chemically induced; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects*; D012107:Research Design; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*; D011795:Surveys and Questionnaires; D013997:Time Factors
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium