High Potency Statins and the Risk of Diabetes

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Statins are a class of cholesterol lowering medications that are prescribed for the prevention and treatment of cardiovascular disease. The purpose of this study is to determine if there is an increased risk of new diabetes when exposed to high potency statins, compared to low potency statins, among patients who had a recent cardiovascular event or procedure.

The investigators will carry out separate population based cohort studies using administrative health care databases in eight jurisdictions in Canada, the US, and the UK. The cohort will be defined by the initiation of a statin, with follow-up until a diagnosis of incident diabetes or a prescription for insulin or an oral antidiabetic medication. The results from the separate sites will be combined in a meta-analysis to provide an overall assessment of the risk of new onset diabetes in subjects starting a statin.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES
• Collaborators: Canadian Institutes of Health Research (CIHR); Drug Safety and Effectiveness Network, Canada
• Treatments: Atorvastatin; Atorvastatin Calcium; Dihydromevinolin; Fluvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; L 647318; Lovastatin; Pravastatin; Rosuvastatin Calcium; Simvastatin

Criteria

Inclusion Criteria:

• Admitted to hospital with a diagnosis (principal or secondary) for acute myocardial infarction or stroke or a procedure for coronary artery bypass graft or percutaneous coronary intervention during their stay in hospital, with no record of a diabetes diagnosis during their hospitalization

• Receipt of a prescription for a statin within 90 days of hospital discharge

• Patients who are at least 40 years of age at cohort entry

• Patients with at least one year of history in the database

Exclusion Criteria:

• Patients under the age of 40 (<66 in jurisdictions with drug data for seniors only)

• Patients with less than one year of history in the database

• Patients who received any cholesterol lowering drugs or diabetes medication/diagnosis in the previous year