The Food and Drug Administration has approved Actos (pioglitazone hydrochloride), a new oral treatment for type 2 diabetes. Developed by Takeda, Actos is the third addition to the class of insulin-sensitizing agents known as thiazolidinediones and is dosed once daily. As an adjunct to diet and exercise, Actos has four therapy indications: monotherapy, and in combination with sulfonylureas, metformin or insulin to improve glycemic control in patients with type 2 diabetes.
The FDA approval was based on review of data from six U.S., double-blind, placebo-controlled studies involving more than 4,500 patients. There have been no reported cases of jaundice or liver failure associated with Actos in the U.S. trials, Takeda said. However, since liver toxicity has been observed with Rezulin, which also is in the TZD class, it is recommended that patients obtain medical monitoring of liver enzyme levels prior to the start of therapy, every two months for the first year of therapy, and periodically thereafter. Takeda will co-promote Actos with Eli Lilly in the United States.
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