The safety of rosuvastatin in comparison with other statins in over 25,000 statin users in the Saskatchewan Health Databases.
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 Saskatchewan Health Databases (SHD) and followed up from 1 July 2003 until 31 March 2005.


RESULTS
We studied 10,384 patients on rosuvastatin and 14,854 taking other statins. Two cases of myopathy were identified (one on rosuvastatin, one on another statin). The relative risk (RR) of myopathy in patients currently taking rosuvastatin compared with other statins was 1.31 (95% confidence interval [CI]: 0.13-13.41). Two cases of rhabdomyolysis were detected among current rosuvastatin users (incidence: 2.9 [95% CI: 0.8-10.7] per 10 000 person-years). No cases of acute liver injury occurred among rosuvastatin patients. Seventeen cases of acute renal failure were identified (five among rosuvastatin users, 12 taking other statins). The RR of acute renal failure in current rosuvastatin users compared with other statins was 0.49 (95% CI: 0.16-1.50). We identified 285 deaths during the study period (87 among rosuvastatin users, 198 taking other statins). The RR of death in current rosuvastatin users compared with other statins was 0.42 (95% CI: 0.32-0.57).


CONCLUSIONS
We found no evidence that patients prescribed rosuvastatin were at greater risk of the study 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
González-Pérez
Antonio
A
Stang
Mary Rose
MR
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; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced / Q000453:epidemiology; D011743:Pyrimidines / Q000009:adverse effects* / Q000627:therapeutic use; D012206:Rhabdomyolysis / Q000139:chemically induced / Q000453:epidemiology; D000068718:Rosuvastatin Calcium; D012525:Saskatchewan / Q000453:epidemiology; D013449:Sulfonamides / Q000009:adverse effects* / Q000627:therapeutic use; D055815:Young Adult
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium