Study Comparing Risk of Hospitalization for Heart Failure Between Dipeptidyl Peptidase-4 Inhibitors and Sulfonylureas

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ACETOHEXAMIDE

  CHLORPROPAMIDE

  GLIMEPIRIDE

  GLIPIZIDE

  NATEGLINIDE

  REPAGLINIDE

  TOLAZAMIDE

  TOLBUTAMIDE

  TOLBUTAMIDE SODIUM
• Anatomical Therapeutic Chemical (ATC) code:
  100000094066

  Dipeptidyl peptidase 4 (DPP-4) inhibitors
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  533577

Study design details

• Main study objective:
  To compare the risk of hospitalization for heart failure between patients with type 2 diabetes mellitus treated with dipeptidyl peptidase-4 inhibitors vs. sulfonylureas
• Outcomes:
  Hospitalization for heart failure: events will be defined as inpatient admission with a principal discharge diagnosis for heart failure (ICD-9-CM 428.xx). Hospitalization for acute myocardial infarction, hospitalization for stroke, hospitalization for unstable angina, coronary revascularization, and a composite of all aforementioned outcomes including hHF (please see protocol for detailed codes and criteria)
• Data analysis plan:
  Propensity scores will be (nearest neighbour technique and enforcing a caliper of 0.01 on the probability scale) derived from a logistic regression model including a wide variety of demographic, insurance, utilization, and clinical variables measured during the baseline period. Outcomes will be compared using bivariate Cox proportional hazards models (i.e. using the exposure of interest cohort membership indicator as the only independent variable) applied to the propensity score matched cohorts. In a sensitivity analysis for only the primary outcome of hHF, hHF will be compared using multivariable Cox proportional hazards models applied to the cohorts before matching. All statistical analyses will be separately conducted in patients with prior cardiovascular disease vs. patients without prior cardiovascular disease.