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In clinical trials, patients taking ACTOS demonstrated no elevation of their liver enzymes when compared to patients taking a placebo.
More than 4,500 people worldwide have taken part in trials for ACTOS. Efficacy and safety data from trials involving 2,600 patients in the United States were recently submitted to the Food and Drug Administration (FDA) for review. Data presented to the FDA showed that elevated liver enzymes occurred in less than 1 percent of ACTOS-treated patients. Those treated with a placebo had similar results.
Comparing Rezulin and ACTOS, James W. Freston, MD, PhD, professor and director of the Office of Clinical Research, University of Connecticut Health Care, says, "This indicates the liver toxicity seen with another drug in this class is unique to that drug and may not reflect a class effect."
Side effects associated with ACTOS at clinical trials included mild upper respiratory tract infection, headache, sinusitis, muscle pain, tooth disorder and inflammation of the pharynx.
Takeda, the Japanese company that manufactures ACTOS, filed a new drug application with the FDA in January. If approved, ACTOS would be used as a stand-alone therapy, or in combination with sulfonylureas, metformin or insulin for the treatment of type 2 diabetes.
The FDA granted priority review status to ACTOS in March.
0 comments - Jul 1, 1999
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