Abstract
BackgroundWe examined the change in the use of rosiglitazone-containing products (RCPs) Canada-wide between 2004 and 2010 and whether the rates of adverse events in association with RCP therapy in Canadian patients changed in this period to better understand the real world use of RCP medications and as part of a regulatory commitment by GlaxoSmithKline to Health Canada to assess whether there was an impact of a risk communication on cardiac safety.MethodsRCP utilization data were obtained from IMS Brogan’s longitudinal de-identified patient database (known as LRx) that tracks prescription activity using store-based data collection from pharmacies in all Canadian provinces. Adverse events (AEs), serious adverse events (SAEs) and cardiac AEs associated with RCP use in Canadian patients between April 2004 and December 2010 were identified from GlaxoSmithKline’s AE database and, using the LRx data, rates per 100,000 patients were estimated.ResultsA total of 239,184 patients were identified as having received at least one RCP prescription between 2004 and 2010 from the LRx. After excluding those with inconsistent gender or age, only one RCP prescription at the pharmacy, a prescription from a pharmacy that had not consistently reported for the past six years or an unreasonably high number of prescriptions, 180,936 patients remained for the analysis. The number of reports identified from the AE database that occurred between April 2004 and December 2010 was 1,037. The average monthly rates of AEs, SAEs and cardiac AEs decreased by 57%, 43% and 4%, respectively, between the observed periods, April 2004-October 2007 and November 2007-December 2010.ConclusionsThe findings of this analysis demonstrate a significant decrease in RCP use in Canada following a meta-analysis publication suggesting harm, which has been maintained. It is not possible to disentangle whether the continuing decline can be attributed to the meta-analysis, the changes in prescribing guidelines, media attention or a combination of some or all of these factors.
Highlights
We examined the change in the use of rosiglitazone-containing products (RCPs) Canada-wide between 2004 and 2010 and whether the rates of adverse events in association with RCP therapy in Canadian patients changed in this period to better understand the real world use of RCP medications and as part of a regulatory commitment by GlaxoSmithKline to Health Canada to assess whether there was an impact of a risk communication on cardiac safety
Following the publication in May 2007 of a metaanalysis [1] that suggested an increased risk of myocardial infarction associated with rosiglitazone-containing products (RCPs), a dramatic decrease in the use of RCPs has been demonstrated in the United States and Europe [2,3,4,5]
To better understand the real world use of RCP medications and as part of a regulatory commitment by GlaxoSmithKline (GSK) to Health Canada to assess whether there was an impact of the risk communication across Canada in terms of decreasing use of RCPs as monotherapy or as part of triple or triple-plus therapy, Number of patients
Summary
We examined the change in the use of rosiglitazone-containing products (RCPs) Canada-wide between 2004 and 2010 and whether the rates of adverse events in association with RCP therapy in Canadian patients changed in this period to better understand the real world use of RCP medications and as part of a regulatory commitment by GlaxoSmithKline to Health Canada to assess whether there was an impact of a risk communication on cardiac safety. To better understand the real world use of RCP medications and as part of a regulatory commitment by GlaxoSmithKline (GSK) to Health Canada to assess whether there was an impact of the risk communication across Canada in terms of decreasing use of RCPs as monotherapy or as part of triple or triple-plus therapy, Number of patients. The commitment required an evaluation of the rates of adverse events (AEs), especially cardiac AEs, in association with RCP therapy in Canadian patients before and after the release of the risk communication
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