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

    Basic Details
    Last Updated
    Monday, April 8, 2024
    Original Posting Date
    Health Outcome(s)
    acute myocardial infarction (AMI)
    hospitalized heart failure
    Methods and Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    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.