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Widely Prescribed Diabetes Drug Falls Short of Promise, Says New Review

A new systematic review calls into the question the health benefits versus risks of an oral medicine widely prescribed for diabetes throughout the United States, Canada, Europe and Asia. //

The drug — called pioglitazone — is marketed in the United States by Takeda Pharmaceuticals North America, Inc., and Eli Lilly and Co. under the trade name Actos.

"Our results showed that published scientific studies of at least 24 weeks of pioglitazone treatment in people with type 2 diabetes mellitus did not provide convincing evidence that patient-oriented outcomes like mortality, morbidity, adverse effects and health-related quality of life are positively influenced by this drug," said lead author Bernd Richter, M.D.

"Until new evidence becomes available, the benefit-risk ratio of pioglitazone therapy in type 2 diabetes mellitus remains unclear," added Richter, assistant professor in the department of endocrinology, diabetes and rheumatology at Heinrich-Heine University in Düsseldorf, Germany.

According to Richter, not only did the review demonstrate no clear-cut benefit to using pioglitazone, but it also showed an increased occurrence of edema and heart failure — including heart failure requiring hospital admission — among patients taking the drug.

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

For the review, the authors analyzed the results of 22 randomized clinical trials involving 6,200 patients with type II diabetes receiving pioglitazone treatment. The longest duration of pioglitazone therapy received by any patient was 34.5 months.

Pioglitazone is one drug in a class of medicines called “thiazolidinediones
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