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Women Using Diabetes Drug Have Increased Bone Fracture Risk

Posted on: Wednesday, 10 December 2008, 14:20 CST

A study released on Wednesday shows that long-term use of GlaxoSmithKline's Avandia and Takeda's Actos doubles the risk of bone fractures in women with type 2 diabetes.

The two thiazolidinedione (TZD) drugs for diabetes were known for some time to be associated with fractures, but the magnitude of the risk had not been evaluated until now.

"Women with type 2 diabetes are already at an increased risk of fractures, so any additional risk from thiazolidinedione therapy could have a considerable impact on public health," said lead author Dr. Yoon Loke, of the University of East Anglia.

Sonal Singh of Wake Forest University School of Medicine said the study shows that these agents double the risk of fractures in women with type 2 diabetes who are already at a higher risk before taking the therapy.

The findings were based on a pooled analysis of 10 previous clinical studies lasting at least a year involving 14,000 patients.

The researchers found that if diabetic women aged around 70 used TZDs for a year, one additional fracture would occur among every 21 women. Among younger women, around age 56, use of the drugs would lead to one extra fracture for every 55 women.

The researchers found no increased risk of fractures among men, however.

Some experts believe these results may add to concerns about the TZD class of drugs, which are already linked to adverse cardiovascular side effects.

Both Avandia, known generically as rosiglitazone, and Actos, or pioglitazone, raise the risks of heart failure and carry strong warnings on their labels.

Avandia sales have plunged since May 2007, after the drug was linked to heart attack risk.

The underlying cause of the sex-specific effect of TZDs on fractures was unclear, according to researchers, but they suggested the drugs might cause the problem by replacing bone marrow with fat cells.

There is no clear evidence that other drugs used to treat type 2 diabetes, such as metformin and sulfonylurea, cause an increased risk of fractures.

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Source: redOrbit Staff & Wire Reports

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