Acute Myocardial Infarction and Hospitalized Heart Failure following Saxagliptin or Sitagliptin Use: A Propensity Score Matched Analysis

Project Title Acute Myocardial Infarction and Hospitalized Heart Failure following Saxagliptin or Sitagliptin Use: A Propensity Score Matched Analysis
Date Posted
Monday, April 1, 2019
Project ID
cder_mpl2r_wp008
Status
In progress
Deliverables
Related Links
Description

This analysis includes (1) a replication of a protocol-based assessment (PBA) of an investigation on acute myocardial infarction (AMI) and hospitalized heart failure (hHF) following saxagliptin or sitagliptin use in comparison to long-acting insulin, pioglitazone, and second-generation sulfonylureas in the Sentinel Distributed Database. It further includes (2) an analysis with data that were unavailable at the time of the PBA.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Medical Product
long-acting insulin
pioglitazone
saxagliptin
second-generation sulfonylurea
sitagliptin
Health Outcome
acute myocardial infarction (AMI)
hospitalized heart failure (hHF)
Population / Cohort
Individuals 18 years of age and older
Time Period
October 1, 2006 - September 30, 2015
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER