Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Endocrinology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved July 1999
Treatment Area: 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.