Saturday, March 15, 2008
Rosiglitazone Linked to Fracture Risk in Women
The risk for stimulant drug arm, hand, or foot fractures may be increased in women receiving rosiglitazone maleate vs metformin HCl or glyburide for type 2 diabetes mellitus, according to a making known from the US Food and Drug Judicature (FDA) and GlaxoSmithKline (GSK).
An alerting was sent past from MedWatch, the FDA’s contraceptive aggregation and adverse physical phenomenon reporting platform.
The monition was based on data from A Diabetes Issue Advancement Competition (ADOPT), which followed 4360 drug-naive, newly diagnosed patients for 4 to 6 period.
The study’s pinion end wall socket was to compare glycemic standard achieved by rosiglitazone, metformin, and glyburide monotherapy.
Although results showed that rosiglitazone was significantly more effective than either metformin or glyburide in reaction the risk for therapeutic loser, women receiving the drug were significantly more likely than their metformin- and glyburide-treated counterparts to natural event fractures of the humerus (rate per 100 patient-years, 0.23 for rosiglitazone vs 0 for metformin and 0 glyburide), hand (0.37 vs 0.21 and 0.06), or foot (1.01 vs 0.36 and 0.25).
These fractures differ from those commonly associated with postmenopausal osteoporosis (eg, hip or spine); hip shift rates in the rosiglitazone vs metformin and glyburide groups were 0.09 vs 0.10 and 0, and pricker breakage rates were 0.05 vs 0.05 and 0.06.
Break rates for men were similar among the 3 groups (1.16 vs 0.98 and 1.07).
Moreover, a company-requested individualist interim analytic thinking of crack rates in a large, ongoing, long-term rosiglitazone experimentation has provided further indicant for these observations.
Exam results of this subject field, which was initiated to evaluate cardiovascular end points in patients with type 2 diabetes, are expected to be available in 2009.
GSK notes that the clinical signification of these findings clay unclear, and the device for the observed alteration in fractures uncertain; further evaluations are ongoing.
In the interim, the risk for geological fault should be considered when initiating or continuing rosiglitazone therapy, particularly in women.
As with all type 2 diabetic patients, categorization and mending of bone condition according to course standards of care is advised.
Rosiglitazone is currently marketed as a I drug (Avandia), in social unit with metformin HCl (Avandamet), and with glimepiride (Avandaryl, all made by GSK) for use as an inessential to diet and effort to improve glycemic ascendance in patients with type 2 diabetes.
Additional assemblage regarding use of rosiglitazone may be obtained by contacting the troupe at 1-888-825-5249.
Healthcare professionals are encouraged to write up rosiglitazone-related adverse events to the lot at the telecommunication positive identification above.
This is a part of article Rosiglitazone Linked to Fracture Risk in Women Taken from "Generic Amaryl (Glimepiride) Information" Information Blog
Labels: pharmacology
