Drug Safety
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Sitagliptin, the first of a new class of dipeptidyl peptidase-4 (DPP-4)-inhibitory oral antihyperglycaemic drugs (OHDs), was introduced in Japan in December 2009. In April 2010 a safety alert was issued regarding the risk of serious hypoglycaemic events, and prescribers were recommended to reduce the dose of sulfonylurea (i.e. glimepiride, glibenclamide [glyburide] or gliclazide) in patients receiving a combination of sulfonylurea and sitagliptin. ⋯ Our results indicate that propensity score matching to control for baseline characteristics of individual patients and prescribers is a useful approach to avoid selection bias and confounding effects in evaluating the influence of an event on prescription behaviour. This case-matched study indicated that sulfonylurea prescription behaviour changed significantly after the sitagliptin safety alert. There was a significant reduction in sulfonylurea dose after the alert in DPP-4 patients, but not in non-DPP-4 patients. Our findings should be helpful for assessing and improving the effectiveness of other regulatory safety alerts.
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Evidence has emerged that pioglitazone may increase the risk of bladder cancer, but the association has not been confirmed. This potential risk also has not been evaluated in users of rosiglitazone. ⋯ Long-term exposures to pioglitazone and rosiglitazone were associated with higher odds of bladder cancer, and the highest odds were seen in users with ≥ 2 years of exposure.