Data from a robust meta-analysis have reinforced concerns about the link between the Type 2 diabetes drug, pioglitazone, and bladder cancer.
The findings support guidance given last year to doctors by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency to regularly review patients' treatment with the drug and to avoid its use in those with a history of, or active, bladder cancer, or uninvestigated haematuria.
Based on three cohort studies involving more than 1.7 million patients, pioglitazone was associated with an estimated 22% increase in the risk of bladder cancer compared with those who had never taken the drug.
"This study quantifies the association between pioglitazone use and bladder cancer and may help inform decisions around safer use of pioglitazone in individuals with type 2 diabetes," say Jeffrey Johnson (University of Alberta, Edmonton, Canada) and colleagues.
The analysis, published in the Canadian Medical Association Journal, examined 10 studies of thiazolidinediones including 2,657,365 patients, with a bladder cancer incidence of 53.1 per 100,000 person-years. Of the five studies assessing pioglitazone exposure, each one reported an elevated or significantly increased risk of bladder cancer compared with patients who had never taken the drug.
However, last year - after assessing all available data at the time - the EMA concluded that the benefits of pioglitazone outweigh the risks for patients who respond well to treatment and have no alternative options.
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