LONDON, July 2 (Reuters) - A new small clinical study suggests diabetes drug Avandia could lead to bone fractures in men as well as women, but maker GlaxoSmithKline Plc (GSK.L) said on Monday the significance of the U.S. trial was limited.
The retrospective study published in the journal Diabetes Care is the first to provide evidence men might be exposed to similar risks as those previously reported in women, with a significant reduction in bone mineral density seen in those taking Avandia.
The bone risk in women was previously highlighted in other trials, including a major one that reported late last year.
The issue has been overshadowed recently, however, by a critical study published in May, which argued Avandia was linked to increased heart attack risk. That news sent prescriptions for Avandia, Glaxo’s second biggest drug, plunging.
Analysts at Morgan Stanley said the latest data was an incremental negative which, coupled with results from past trials, added to the likelihood Avandia’s label would be toughened to include stronger warnings about bone safety.
Glaxo, however, cautioned against reading too much into the latest results.
“The findings of this study are limited as it involves very low patient numbers and, as a retrospective study, it is not possible to draw meaningful comparisons nor rule out confounding factors, such as age and duration of diabetes,” a spokesman said in an emailed statement.
((Reporting by Ben Hirschler; editing by Sue Thomas; email: email@example.com; Reuters Messaging: firstname.lastname@example.org; +44 20 7542 5082)) Keywords: GLAXO AVANDIA/
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