Utilization of Rosiglitazone in Triple Therapy and Insulin Combinations and Estimated Rates of Adverse Events in Rosiglitazone Recipients in Canada, 2011-2012

Trial description: Objectives: (1) To assess the extent to which rosiglitazone was used in triple therapy combination with other oral anti-diabetic agents or insulin between 2011 and 2012. (2) To assess the extent to which rosiglitazone was used in combination with insulin between 2011 and 2012. (3) To estimate rates of adverse events (AEs), serious adverse events (SAEs) and cardiac AEs in association with rosiglitazone therapy between 2011 and 2012, using AEs in Canadian patients reported to GlaxoSmithKline's (GSK's) global AE reporting database. Methods: Patients dispensed prescriptions for rosiglitazone-containing products (RCPs), either alone or in combination with other anti-diabetic agents, between January 1, 2011 and December 31, 2012, will be identified from IMS Health Canada Inc.'s longitudinal de-identified patient database, LRx. LRx tracks prescription activity using store based data collection from pharmacies in all Canadian provinces. Rosiglitazone utilization, as monotherapy or in combination with other oral anti-diabetic agents and/or insulin, will be classified on a monthly basis. Use of rosiglitazone-containing products in triple therapy and in combination with insulin will be assessed overall and stratified by patient age <70 years and ≥70 years. Estimated rates of AEs, SAEs, and cardiac AEs between January 1, 2011 and December 31, 2012 will be calculated on a quarterly basis by grouping AEs, SAEs and cardiac AEs in Canadian RCP recipients recorded in GSK's global AE reporting database by calendar month and using the IMS LRx-dervied number of RCP recipients as the denominator.