Approved July 1999
Diabetes / Endocrinology
ACTOS has been approved for the treatment of type II diabetes. ACTOS is the newest addition to the class of insulin sensitizing diabetes agents known as thiazolidinediones (TZDs), and is always dosed once daily without regard to meals. 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 II diabetes.
The FDA approval was based on a review of data from 6 U.S. studies involving more than 4,500 patients with type II diabetes. In each trial, there was a statistically significant reduction in blood glucose levels.
The majority of side effects reported during clinical trials were mild. The most commonly reported included symptoms of upper respiratory tract infection, headache, sinusitis, muscle pain, tooth disorder, and sore throat.
Patients with type II diabetes often have high triglyceride levels and low levels of HDL or "good" cholesterol. These 2 abnormalities increase the risk for heart disease, especially in patients with diabetes. Importantly compared with placebo, ACTOS significantly decreased mean triglyceride levels and increased mean HDL levels in both monotherapy and in combination with sulfonylureas, metformin, or insulin. In contrast, no significant change in mean total cholesterol or mean LDL or "bad" cholesterol levels was seen with ACTOS used either as monotherapy or in combination therapy.
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