Utilization of Rosiglitazone in Triple Therapy and Insulin Combinations, and Estimated Rates of Adverse Events in Rosiglitazone Recipients in Canada, 2004-2010

Trial description: Objectives:To assess the extent to which rosiglitazone was used in triple therapy combination with other oral anti-diabetic agents or insulin between 2004 and 2010To assess the extent to which rosiglitazone was used in combination with insulin between 2004 and 2010To estimate rates of adverse events (AEs), serious adverse events (SAEs) and cardiac AEs in association with rosiglitazone therapy between 2004 and 2010 using AEs in Canadian patients reported to GlaxoSmithKline’s global AE reporting database.Brief Methods:The data for the analysis were obtained from a database (LRx) belonging to IMS Health Consulting that tracks the prescription activity of patients over time using store-based data collection from pharmacies in all Canadian provinces. The LRx database was used to identify patients dispensed prescriptions for rosiglitazone alone or in combination with other antidiabetics between January 2004 and December 2010. Concomitant use of rosiglitazone with other oral anti-diabetics or insulin was calculated on a monthly basis. Rosiglitazone utilization in triple therapy and in combination with insulin was assessed overall and stratified by age into patients <70 years and ≥70 years. To estimate rates of AEs, AEs, SAEs and cardiac AEs related to all rosiglitazone-containing products occurring in Canadian patients between 2004 and 2010 were identified from GlaxoSmithKline’s global AE reporting database grouped by calendar month. Estimated rates of adverse events were calculated on a quarterly basis for 2004 2010 using the IMS-derived number of patients as the denominator.