This request has two components. Part 1 (cder_mpl2r_wp008) includes a replication of a protocol-based assessment (PBA) of an investigation on acute myocardial infarction (AMI) and heart failure following saxagliptin or sitagliptin use in comparison to long-acting insulin, pioglitazone, and second-generation sulfonylureas in the Sentinel Distributed Database (SDD). Part 2 (cder_mpl2r_wp011) includes an analysis with data that were unavailable at the time of the PBA and accounted for present-day drugs and analysis tool capabilities.
Part 1 contains four reports. Reports 1 and 3 contain data from August 1, 2009 to July 31, 2014. Reports 2 and 4 contain data from October 1, 2006 to July 31, 2014. We distributed this request to 13 Data Partners contributing to the SDD on September 10, 2019.
Part 2 contains four reports. Reports 1 and 3 contain data from August 1, 2009 - September 30, 2015. Reports 2 and 4 contain data from October 1, 2006 - September 30, 2015. We distributed this request to 16 Data Partners contributing to the SDD on July 29, 2019.
The analytic packages associated with these analyses can be found externally in Sentinel's Git Repository located here: Package 1, Package 2. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.