The safety of rosuvastatin in comparison with other statins in over 100,000 statin users in UK primary care.
OBJECTIVE
To compare mortality and the incidence of hospitalization for myopathy, rhabdomyolysis, acute renal failure and acute liver injury in patients receiving rosuvastatin and those taking other statins.


METHODS
Patients prescribed a statin that they had not used before were selected from the UK General Practice Research Database (GPRD) and followed up from 1 April 2003 to 31 December 2005.


RESULTS
We studied 10 289 patients on rosuvastatin and 117 102 taking other statins. No cases of myopathy, rhabdomyolysis or acute liver injury occurred among rosuvastatin users. In those taking statins other than rosuvastatin, the incidence of myopathy was 0.4 (95% confidence interval (CI): 0.1-0.9), of rhabdomyolysis was 0.4 (95%CI: 0.1-0.9) and of acute liver injury was 0.4 (95%CI: 0.2-1.0), per 10 000 person-years. Fourteen cases of acute renal failure were identified (two among rosuvastatin users and 12 among other statin users). Among current users, the relative risk (RR) of acute renal failure in rosuvastatin users compared with other statin users was 1.16 (95%CI: 0.15-9.03).We identified 3232 deaths during the study period (173 in the rosuvastatin-treated group and 3059 in the other statin group). The RR of death associated with current use of rosuvastatin compared with other statins was 0.55 (95%CI: 0.44-0.68).


CONCLUSIONS
We found no evidence that patients prescribed rosuvastatin were at greater risk of these outcomes than patients prescribed other statins. There was no evidence of increased mortality among patients taking rosuvastatin, even after allowing for age, sex and prior statin use.
García-Rodríguez
Luis Alberto
LA
Spanish Centre for Pharmacoepidemiological Research (CEIFE), Madrid, Spain. lagarcia@ceife.es
Massó-González
Elvira Luján
EL
Wallander
Mari-Ann
MA
Johansson
Saga
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D016208:Databases, Factual / Q000706:statistics & numerical data; D005260:Female; D005464:Fluorobenzenes / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced / Q000453:epidemiology; D011320:Primary Health Care / Q000706:statistics & numerical data*; D011743:Pyrimidines / Q000009:adverse effects* / Q000627:therapeutic use*; D012206:Rhabdomyolysis / Q000139:chemically induced / Q000453:epidemiology; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000009:adverse effects* / Q000627:therapeutic use*; D006113:United Kingdom / Q000453:epidemiology; D055815:Young Adult
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium