Incretin-based Drugs and the Risk of Heart Failure

What this study is testing ClinicalTrials.gov NCT02456428 ↗

Description as written by the study sponsor.

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.

Treatments tested

• DPP-4 inhibitors also known as incretin-based drugs, sitagliptin, vildagliptin, saxagliptin Drug

  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.

• GLP-1 analogs also known as incretin-based drugs, exenatide, liraglutide Drug

  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.

• Insulins also known as insulins and analogues for injection, fast-acting, insulins and analogues for injection, intermediate-acting, insulins and analogues for injection, long-acting, insulins and analogues for inhalation Drug

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

• Biguanides also known as oral hypoglycemic agent, phenformin, metformin, buformin Drug

  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.

• Sulfonylureas also known as oral hypoglycemic agent, glibenclamide, chlorpropamide, tolbutamide, glibornuride, tolazamide, carbutamide, glipizide, gliquidone, gliclazide, metahexamide, glisoxepide, glimepiride, acetohexamide, glymidine Drug

  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.

• Thiazolidinediones also known as oral hypoglycemic agent, troglitazone, rosiglitazone, pioglitazone Drug

  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.

• Alpha-glucosidase inhibitors also known as oral hypoglycemic agent, acarbose, miglitol, voglibose Drug

  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.

• Meglitinides also known as oral hypoglycemic agent, repaglinide, nateglinide Drug

  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.