Incretin-based Drugs and the Risk of Heart Failure

Summary

The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone or in combination with other anti-diabetic drugs are associated with an increased risk of heart failure (HF) compared to other combinations of oral hypoglycemic agents (OHA).

The investigators will carry out separate population based cohort studies using administrative health databases in six jurisdictions in Canada, the US and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for HF. Analyses will be done separately for groups of patients with and without prior HF. The results from the separate sites will be combined to provide an overall assessment of the risk of HF in users of incretin-based drugs and by class of incretin-based drugs.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

DPP-4 inhibitors

Current exposure to DPP-4 inhibitors (ATC A10BH, A10BD07-A10BD13) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.

DRUG

GLP-1 analogs

Current exposure to GLP-1 analogs (ATC A10BX04, A10BX07) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.

DRUG

Insulins

Current exposure to insulin (ATC A10A) will be defined as any use of insulin between base cohort entry and the index day.

DRUG

Biguanides

Current exposure to biguanides (ATC A10BA) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.

DRUG

Sulfonylureas

Current exposure to sulfonylureas (ATC A10BB or A10BC) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.

DRUG

Thiazolidinediones

Current exposure to thiazolidinediones (ATC A10BG) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.

DRUG

Alpha-glucosidase inhibitors

Current exposure to alpha-glucosidase inhibitors (ATC A10BF) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.

DRUG

Meglitinides

Current exposure to meglitinides (ATC A10BX02, A10BX03) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index (event)day.

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

• Pierre Ernst, MD, MSc · Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2015-05-31

Completion

2015-05-31

Countries

• Canada

Study Locations