Abstract
BackgroundWe previously reported on the change in the use of rosiglitazone-containing products (RCP) and adverse event reporting rates in Canadian patients between 2004 and 2010. The present study extends this analysis to include the January 2011 to December 2012 time period.MethodsRCP utilization rates were obtained from IMS Health Brogan’s longitudinal de-identified patient database, LRx. GlaxoSmithKline’s global adverse events database was used to extract adverse events (AE), serious adverse events (SAE), and cardiac adverse events (CAE) reported in Canadian patients receiving RCP from April 2004 to December 2012. The patient utilization information from the LRx database was used to estimate rates per 100,000 patients.ResultsAn estimated 182,841 patients were dispensed RCP prescriptions between April 2004 and December 2012. The total number of patients using RCP decreased by 85 % from 2011 to 2012. From its peak use in 2007, the number of patients filling a prescription decreased 97 %. A total of 1069 AEs were reported during the study period, of which 32 AE’s were reported from Jan 2011 to Dec 2012. The average monthly reporting rates of AE’s, SAE’s and CAE’s over 2011–2012 were 10.8/100,000 patients, 9.1/100,000 patients and 5.0/100,000 patients, respectively.ConclusionsThe utilization of RCP in Canada has significantly declined. The significance of the adverse event rate information presented is uncertain and must be evaluated within the context of the well known factors that can influence AE reporting rates, as well as limitations to the methods used to estimate these reporting rates.
Highlights
We previously reported on the change in the use of rosiglitazone-containing products (RCP) and adverse event reporting rates in Canadian patients between 2004 and 2010
In contrast with the findings of the 2007 meta-analysis, this trial’s results found no increased risk of cardiovascular death, myocardial infarction or stroke associated with RCP use compared with standard glucose-lowering drugs in people with type 2 diabetes mellitus [2]
At the request of the United States (US) Food and Drug Administration (FDA), an independent comprehensive, expert re-evaluation of the RECORD data was conducted by the Duke Clinical Research Institute (DCRI)
Summary
We previously reported on the change in the use of rosiglitazone-containing products (RCP) and adverse event reporting rates in Canadian patients between 2004 and 2010. The present study extends this analysis to include the January 2011 to December 2012 time period. Rosiglitazone, a member of the thiazolidinedione class of oral anti-diabetic agents, improves glycemic control in patients with type 2 diabetes mellitus by improving insulin sensitivity, decreasing insulin resistance and lowering blood glucose levels. In May 2007, the publication of a meta-analysis evaluating the effect of rosiglitazone on cardiovascular morbidity and mortality generated significant public attention. The analysis found rosiglitazone treatment was associated with a statistically significant increased risk of myocardial infarction (OR 1.43, CI 1.03–1.98) in comparison with the use of placebo or other anti-diabetic agents [1]
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