High Potency Statins and Acute Kidney Injury

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.

Conditions

• Hypercholesterolemia

Interventions

DRUG

Rosuvastatin (≥10 mg)

Current cumulative exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed \>120 days of the index date (i.e. no exposure within 120 days of the index date).

DRUG

Atorvastatin (≥20 mg)

Current cumulative exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed \>120 days prior to the index date (i.e. no exposure within 120 days of the index date).

DRUG

Simvastatin (≥40 mg)

Current cumulative exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg simvastatin dispensed \>120 days prior to the index date (i.e. no exposure within 120 days of the index date).

DRUG

Fluvastatin

Current cumulative exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed \>120 days prior to the index date (i.e. no exposure within 120 days of the index date).

DRUG

Pravastatin

Current cumulative exposure to pravastatin (ATC C10AA03) will be defined as a prescription for any dose of pravastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to pravastatin will be defined as a prescription for any dose of pravastatin (ATC C10AA03) dispensed \>120 days prior to the index date (i.e. no exposure within 120 days of the index date).

DRUG

Lovastatin

Current cumulative exposure to lovastatin (ATC C10AA02) will be defined as a prescription for any dose of lovastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to lovastatin will be defined as a prescription for any dose of lovastatin (ATC C10AA02) dispensed \>120 days prior to the index date (i.e. no exposure within 120 days of the index date).

DRUG

Atorvastatin (<20mg)

Current cumulative exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for \<20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for \<20 mg of atorvastatin dispensed \>120 days prior to the index date (i.e. no exposure within 120 days of the index date).

DRUG

Simvastatin (<40 mg)

Current cumulative exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for \<40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days). Past exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for \<40 mg simvastatin dispensed \>120 days prior to the index date (i.e. no exposure within 120 days of the index date).

Sponsors & Collaborators

• Drug Safety and Effectiveness Network, Canada

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Canadian Network for Observational Drug Effect Studies, CNODES

  lead OTHER

Principal Investigators

• Colin Dormuth, M.Sc., Sc.D. · Departments of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver,BC

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2013-01-31

Completion

2013-01-31

Countries

• Canada

Study Locations