High Potency Statins and Acute Kidney Injury

• Status: Completed
• Trial end date: 2013-01-01
• 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 excess risk of acute kidney injury (AKI) with high potency statins compared to low potency statins.

The investigators will carry out separate population based cohort studies using administrative health care databases in nine jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a statin, with follow-up until hospitalization for AKI. Analyses will be done separately for groups of patients with and without chronic kidney disease. The results from the separate sites will be combined in a meta-analysis to provide an overall assessment of the risk of AKI in new statin users.

• 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:

• Patients with a new prescription for a statin from the earliest availability of data at each site to the last date of availability of data +365 days

• 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 (including fibrates, niacin and ezetimibe) or underwent dialysis or a kidney transplant in the previous year