NEW YORK (Reuters Health) Dec 10 - The results of a meta-analysis provide further evidence that use of rosiglitazone and pioglitazone increases the risk of fractures in women with type 2 diabetes. In men, by contrast, no elevated risk is seen.
To assess the risk of fracture with these agents, Dr. Yoon K. Loke from the University of East Anglia, Norwich, UK, and colleagues searched MEDLINE, EMBASE, and other sources to identify relevant studies. Included in the team's analysis were 10 randomized trials that included 13,715 subjects, and two observational studies involving 31,679 subjects.
In the full analysis of the trial data, use of thiazolidinediones for a year or longer increased the odds of fracture by 45%, according to the report in the January 6th issue of the Canadian Medical Association Journal. The results from the observational studies also indicated a link between use of these agents and fractures.
Analysis of data from five trials showed that thiazolidinedione use more than doubled the fracture risk in women, but had no significant effect in men.
Data from two randomized trials indicated that thiazolidinedione-exposed women had significantly reduced bone mineral density at the lumbar spine and hip than did their non-exposed peers.
In a related editorial, Dr. Lorraine L. Lipscombe, from the University of Toronto, comments that "the ongoing accumulation of evidence of harm for thiazolidinediones is unsettling to clinicians and patients and threatens to undermine patient confidence."
She adds that the present study "highlights the need for routine and standardized postmarketing surveillance strategies to be implemented for new drugs, so that both patients and clinicians can be assured that unexpected adverse effects are monitored and reported on a regular basis."
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