Rosiglitazone use and associated adverse event rates in Canada between 2004 and 2010

BMC Research Notes

Jorge A Ross Terres¹  Nigel SB Rawson² 

[1] Medical Affairs, GlaxoSmithKline Inc., 7333 Mississauga Road, Mississauga, ON, L5N 6L4, Canada;Eastlake Research Group, 511 Maple Grove Road, P.O. Box 61028, Oakville, ON, L6J 7P5, Canada

关键词: Risk communication;    Adverse events;    Prescription data;    Rosiglitazone;   

Others  :  1143360
DOI  :  10.1186/1756-0500-6-82

 received in 2012-07-09, accepted in 2013-02-25,  发布年份 2013

【 摘 要 】

Background

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.

Methods

RCP 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.

Results

A 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.

Conclusions

The 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.

【 授权许可】

   
2013 Rawson and Terres; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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