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Analysis finds no Actos bladder cancer link

Published on 08/12/14 at 08:16am
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A large-scale analysis of patient data has found that pioglitazone, the diabetes drug that is the subject of ongoing safety lawsuits, is not associated with an increased risk of bladder cancer.

Pioglitazone works by helping patients with type 2 diabetes to control their blood glucose levels. Prior to 2012, pioglitazone was owned and marketed by Takeda and Lilly as Actos, however its patent is now expired and it is now sold by a number of generic companies as pioglitazone in the UK, US and other EU countries.

In 2011 the FDA announced that using Actos for more than one year could be associated with an increased risk of bladder cancer, after a conducting a safety review into the medicine. Studies in patients in France and Germany also found an increased risk of bladder cancer in patients who were prescribed Actos for two or more years.

Governments in France and Germany banned Actos after the FDA’s announcement, although the EMA did not pull the drug from the market. Since these studies were published there have been a number of contradictory study findings on the safety of pioglitazone, due to flaws in study designs, small studies or the effects of bias.

The latest meta-analysis, by researchers from the University of Dundee, analysed data from 1,000,000 patients from six centres in Canada, Netherlands and the UK. The researchers analysed details of prescriptions of Actos and other drugs, and compared these data to diagnoses and deaths from bladder cancer, over a follow-up period of four to seven and a half years.

There were 3,248 cases of bladder cancer diagnosed in patients during the study: 3,131 in patients who had never taken Actos and 117 in patients who had taken Actos. But the analysis found no link between Actos and bladder cancer, after taking into account differences between the two groups in age, calendar year, diabetes duration, smoking and any use of pioglitazone or other diabetes drugs.

The researchers conclude: “The direction of effect varied between populations but was not significant within any population; overall, there was no evidence of any association…. Furthermore, there was no evidence for an association with ever exposure in men or women.” The study is published in the journal Diabetologia.

Bladder cancer is the ninth most common cancer in the world, with 430,000 new cases diagnosed in 2012. Europe and North America have the highest incidence of bladder cancer globally, and the incidence of bladder cancer is even higher in people with diabetes.

Lilian Anekwe

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