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Onglyza (Saxagliptin) and Januvia (Sitagliptin) & Acute Myocardial Infarction (AMI) and Hospitalized Heart Failure

Basic Details
Status
Complete
Last Updated
Monday, April 8, 2024
Original Posting Date
Health Outcome(s)
acute myocardial infarction (AMI)
hospitalized heart failure
Purpose
Methods and Development
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

The purpose of this study was to assess whether Active Risk Identification and Analysis (ARIA) system tools could replicate the results of prior protocol-based assessments (PBAs) that evaluated acute myocardial infarction (AMI) and hospitalized heart failure risk following saxagliptin or sitagliptin use in comparison to long-acting insulins, pioglitazone, and second-generation sulfonylureas in the Sentinel Distributed Database (SDD). The study found that Sentinel modular programs were able to reproduce findings of prior PBAs which did not indicate an increased risk of AMI or hospitalized heart failure associated with saxagliptin or sitagliptin exposure.

Analytic Code Link(s) (1)
Acute Myocardial Infarction and Heart Failure following Saxagliptin or Sitagliptin Use: A Propensity Score Matched Analysis
Result(s) (1)
Acute Myocardial Infarction and Heart Failure following Saxagliptin or Sitagliptin Use: A Propensity Score Matched Analysis
Related Publication(s) and/or Presentation(s) (3)
Publication: Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study Publication: Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study Presentation: Replication of Protocol-Based Analyses of Saxagliptin and Sitagliptin using Sentinel Modular Programs