Study Results
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Basic Information
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COMPLETED
136966 participants
OBSERVATIONAL
2012-07-31
2013-02-28
Brief Summary
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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.
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Detailed Description
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Study population
In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for a statin (after hospital discharge), including simvastatin, lovastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin, from the earliest availability of data at each site to the last date of available data. The date of study cohort entry is defined by the prescription date of the newly-prescribed statin. Patients will be followed from the date of study cohort entry until an event (defined below) or censoring due to death, departure from the database, 24 months after the initiation of statin treatment, a dispensing for cerivastatin, or the end of the study period (31 March 2011 or the last date of data availability at that site), whichever occurs first. Data from Alberta, Ontario, and Nova Scotia will be restricted to patients aged 65 years and older as prescription data are not available for younger patients.
Case-control selection
The cohort defined above will be analyzed using a nested case-control analysis, where cases are defined as a hospitalization for incident diabetes or the prescription for an insulin or an oral antidiabetic medication. Risk set sampling will be used to randomly select up to 10 controls for each case, matched on sex, age (± two years; however, if no controls are available, within five years), and cohort entry (± 90 days).
Exposure assessment
The exposure categories will be separated by statin potency (high vs. low dose), and the duration of current exposure. For all cases and controls, exposure will be defined hierarchically; more specifically, patients who receive both a high and low potency statin within the same exposure category will be classified as high potency statin users. Current use of a high potency statin will be defined by the last prescription for a high dose statin prior to the index date. Current users will be further classified into three mutually exclusive durations of current exposure (≤120, 121-365, and 366-730 days).
Statistical analyses
Conditional logistic regression will be used to estimate the odds ratios and corresponding 95% confidence intervals (CIs) of the association between statin use and the diabetes endpoint, comparing current use of high potency statins to low potency statins. This is considered the primary analysis. Several sensitivity analyses will be performed to assess the robustness of study results and address some of the study limitations. High dimensional propensity scores will be estimated for all patients in the cohorts using logistic regression. Finally, all site-specific estimates will be meta-analyzed using fixed or random-effects models with inverse variance weighting. The amount of between-site heterogeneity will be estimated using the I square statistic.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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High potency statin users
Exposure will be defined as a new prescription for a high dose statin (high doses of rosuvastatin, high doses of atorvastatin, and high doses of simvastatin) between 1 January 1997 and 31 March 2011, or 1 year after the beginning of data availability.
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).
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).
Simvastatin (≥40 mg)
Current cumulative exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg of simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-\<365 days, or 366-730 days).
Low potency statin users
Exposure will be defined as a new prescription for a low dose statin (all doses of fluvastatin, all doses of pravastatin, all doses of lovastatin; low doses of atorvastatin and simvastatin) between 1 January 1997 and 31 of March 2011, or 1 year after the beginning of data availability.
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).
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).
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).
Rosuvastatin (<10mg)
Current cumulative exposure to low dose rosuvastatin (ATC C10AA07) will be defined as a prescription for \<10mg 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).
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).
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).
Interventions
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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).
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).
Simvastatin (≥40 mg)
Current cumulative exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg of simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-\<365 days, or 366-730 days).
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).
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).
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).
Rosuvastatin (<10mg)
Current cumulative exposure to low dose rosuvastatin (ATC C10AA07) will be defined as a prescription for \<10mg 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).
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).
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).
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
ALL
No
Sponsors
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Drug Safety and Effectiveness Network, Canada
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canadian Network for Observational Drug Effect Studies, CNODES
OTHER
Responsible Party
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Principal Investigators
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Colin Dormuth, M.Sc., Sc.D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver,BC
References
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Dormuth CR, Filion KB, Paterson JM, James MT, Teare GF, Raymond CB, Rahme E, Tamim H, Lipscombe L; Canadian Network for Observational Drug Effect Studies Investigators. Higher potency statins and the risk of new diabetes: multicentre, observational study of administrative databases. BMJ. 2014 May 29;348:g3244. doi: 10.1136/bmj.g3244.
Related Links
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This organization's website describing general functions, other CNODES projects, and investigator profiles.
Other Identifiers
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Q12-02
Identifier Type: -
Identifier Source: org_study_id
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