Issue 150 Item 12 FDA Approves Avandia For Use In Combination With Insulin

New combination can help to reduce the amount of insulin required to control blood glucose therefore, possibly allowing for easier weight loss for Type 2’s Avandia now can be used in four therapeutic regimens: as monotherapy or as combination therapy with metformin, sulfonylureas or insulin to improve glycemic control in patients with type 2 diabetes.

Avandia in combination with insulin. The approval of Avandia in combination with insulin was based upon data from four 26-week trials in patients with type 2 diabetes. Approximately 1,100 patients participated in clinical studies programs, which included two fixed-dose combination trials, one insulin reduction study, and one study in patients with chronic kidney disease. The studies demonstrated the safety and efficacy of Avandia at 4 mg daily in combination with insulin. In fact, in patients receiving Avandia 4 mg daily plus insulin, there was a significant drop in blood sugar levels and approximately 40% of patients in the two fixed-dose trials were able to reduce their insulin dose.

Avandia is an insulin sensitizer that works by making the cells in the body more sensitive to its own natural insulin. Since FDA approval of Avandia in May 1999, more than 22 million prescriptions have been written and more than 3 million patients have been treated in the United States. Some people may experience tiredness, weight gain or swelling with Avandia.