FRIDAY, Oct. 20, 2006 (HealthDay News) -- It's unclear whether the health benefits outweigh the risks of the widely prescribed diabetes drug pioglitazone (brand name Actos), say the authors of a review that examined 22 studies of the drug involving 6,200 type 2 diabetes patients.
"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," lead author Dr. Bernd Richter said in a prepared statement.
Not only were he and his colleagues unable to identify any definite benefit from taking pioglitazone, they also found that patients taking the drug had increased rates of edema (fluid buildup and swelling) and heart failure.
They also concluded that the drug may cause dangerous drops in blood glucose in people taking pioglitazone in combination with another class of drugs called sulfonylureas, which include medications such as tolbutamide, glipizide and glimepiride, among others.
"Until new evidence becomes available, the benefit-risk ratio of pioglitazone therapy in type 2 diabetes mellitus remains unclear," said Richter, an assistant professor in the department of endocrinology, diabetes and rheumatology at Heinrich Heine University in Germany.
Richter said pioglitazone treatment should be restricted to patients who show real benefits -- fewer diabetic complications and improved health-related quality of life -- from taking the drug. The findings are published in the current issue of The Cochrane Library journal.
Pioglitazone belongs to a family of drugs called thiazolidinediones. These kinds of drugs are designed to increase the body's sensitivity to naturally produced insulin to foster better uptake of glucose into cells and lower blood-glucose levels.
"The kernel from this review is that pioglitazone is effective in glucose-lowering, has some other beneficial and potentially harmful associated features, and just has not been evaluated in the right way to prove that it will help people lead longer and more productive lives," Dr. John Buse, director of the Diabetes Care Center at the University of North Carolina School of Medicine at Chapel Hill, said in a prepared statement.
"This is true for essentially every drug available for the treatment of diabetes," noted Buse, who was not involved in the review.
More information
The U.S. National Library of Medicine has more about pioglitazone.
