High Potency Statins and the Risk of Diabetes

NCT02518503 | Completed

• 1 other identifier: Q12-02
• Study Type: observational
• Target: 136,966
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Disease

Keywords

Diabetes Mellitus; Statins; HMG-CoA reductase inhibitors

Outcome Measures

Primary Outcomes (1)

• Number of participants with Incident type 2 diabetes

  Patients with a first-hospitalization, receiving a principle or secondary diagnosis for diabetes (ICD-9: 250; ICD-10: E10, E11, E12, E13, E14), or a prescription for insulin or an oral antidiabetic medication.

  Patients will be followed from the date of study cohort entry until either hospitalization for diabetes or censoring (whichever occurs first), or will be assessed for up to 24 months.

Study Arms (2)

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.

Drug: Rosuvastatin (≥10 mg); Drug: Atorvastatin (≥20 mg); Drug: Simvastatin (≥40 mg)

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.

Drug: Fluvastatin; Drug: Pravastatin; Drug: Lovastatin; Drug: Rosuvastatin (<10mg); Drug: Atorvastatin (<20mg); Drug: Simvastatin (<40 mg)

Interventions

Rosuvastatin (≥10 mg) DRUG

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).

High potency statin users

Atorvastatin (≥20 mg) DRUG

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).

High potency statin users

Simvastatin (<40 mg) DRUG

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).

Low potency statin users

Fluvastatin DRUG

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).

Low potency statin users

Pravastatin DRUG

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).

Low potency statin users

Lovastatin DRUG

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).

Low potency statin users

Rosuvastatin (<10mg) DRUG

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).

Low potency statin users

Atorvastatin (<20mg) DRUG

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).

Low potency statin users

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for a statin, including simvastatin, lovastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin between 1 January 1998 (or one year after the beginning of data availability) and 31 March 2011. The date of study cohort entry is defined by the prescription date of the newly-prescribed statin after hospital discharge.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Network for Observational Drug Effect Studies, CNODES: lead
• Drug Safety and Effectiveness Network, Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Related Publications (1)

• 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.

  PMID: 24874977 RESULT

Related Links

• This organization's website describing general functions, other CNODES projects, and investigator profiles.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Diabetes Mellitus

Interventions

Rosuvastatin Calcium; Atorvastatin; Simvastatin; Fluvastatin; Pravastatin; Lovastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Colin Dormuth, M.Sc., Sc.D.

  Departments of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver,BC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 7, 2015
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 14, 2016

Record last verified: 2015-08