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The safety of rosuvastatin in comparison with other statins in over 25,000 statin users in the Saskatchewan Health Databases,,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2008
Luis Alberto García-Rodríguez MD
Abstract Purpose 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. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Statin use in Type 2 diabetes mellitus is associated with a delay in starting insulin

DIABETIC MEDICINE, Issue 9 2004
A. Yee
Abstract Aims It has been suggested that HMG Co-A reductase inhibitors (,statins') may reduce the risk of developing Type 2 diabetes mellitus. This study was designed to evaluate whether use of statins would also delay progression to insulin therapy. Methods This was a retrospective cohort study using Saskatchewan Health databases to identify subjects newly started on oral antidiabetic agents from 1991 to 1996. Subjects < 30 years of age or with previous lipid-lowering drug use were excluded. Medications known to influence glycaemic control, co-morbidity, and demographic data were collected. Statin exposure was defined as at least 1 year of use. Primary outcome was starting insulin treatment. Multivariate Cox proportional hazards models were used to examine the association between statin use and starting insulin. Results The final cohort included 10 996 new users of oral antidiabetic agents, of which 484 (4.4%) used statins. Mean age was 64 years and 55% were male. Mean duration of follow-up was 5.1 years; 11.1% (n = 1221) eventually started insulin treatment. Statin users were no less likely than non-users to start insulin treatment eventually (11.6% vs. 11.1%, P = 0.74). After multivariate adjustment, however, statin use was associated with a 10-month delay before newly treated diabetic subjects needed to start insulin treatment (adjusted hazard ratio 0.74; 95% confidence interval 0.56, 0.97, P = 0.028). Conclusion The use of statins is associated with a delay in starting insulin treatment in patients with Type 2 diabetes initially treated with oral antidiabetic agents. Whether this relationship exists for patients at high risk of developing diabetes should be examined in a randomized trial. [source]

Positive predictive value of ICD-9 codes 410 and 411 in the identification of cases of acute coronary syndromes in the Saskatchewan Hospital automated database

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2008
Cristina Varas-Lorenzo MD
Abstract Background Case definitions are essential to epidemiological research. Objectives To evaluate ICD-9 codes 410 and 411 to identify cases of acute coronary syndromes (ACS), and the clinical information availability in the administrative and hospital discharge records of Saskatchewan, Canada. Methods In the context of a safety cohort study, we identified hospitalisations with primary discharge codes 410 (2260) and 411 (799). We selected all records with code 411, and a random sample (200) with code 410. Based on information obtained by trained abstractors from hospital records, events were classified by two cardiologists as definite or possible according to adapted AHA/ESC criteria. The validity of 410 and 411 codes was assessed by calculating the positive predictive value (PPV). Completeness of the recorded information on risk factors and use of aspirin was explored. Results The PPVs of the codes 410 and 411 for ACS were 0.96 (95%CI: 0. 92,0.98) and 0.86 (95%CI: 0.83,0.88), respectively. The PPV of 410 for acute myocardial infarction (AMI) was 0.95 (95%CI: 0.91,0.98). The PPV of 411 was 0.73 (95%CI: 0.70,0.77) for primary unstable angina (UA) and 0.09 (95%CI: 0.07,0.11) for AMI. Hospital charts review revealed key information for clinical variables, smoking, obesity and use of aspirin at admission. Conclusions ICD-9 410 code has high PPV for AMI cases, likewise 411 for UA cases. Case validation remains important in epidemiological studies with administrative health databases. Given the pathophysiology of ACS, both AMI and UA might be used as study end points. In addition to code 410, we recommend the use of 411 plus validation. Copyright © 2008 John Wiley & Sons, Ltd. [source]