Bristol-Myers Squibb Company and Sanofi-Synthelabo announced that the U.S. Food and Drug Administration (FDA) have approved Avapro (irbesartan) for a new indication: the treatment of diabetic nephropathy (kidney disease) in people who have hypertension and type 2 diabetes. In the United States, approximately 50 million people suffer from high blood pressure and approximately 17 million from diabetes. An estimated one third of patients with diabetes will develop chronic kidney failure, which requires dialysis or a kidney transplant. Avapro, an angiotensin II receptor blocker (ARB) was originally approved by the FDA in 1997 for use in treating high blood pressure (hypertension).
The FDA approval is based on results from the Irbesartan Diabetic Nephropathy Trial (IDNT) which studied patients with high blood pressure, type 2 diabetes and evidence of kidney disease. Data from the IDNT trial, demonstrated that when these patients were treated with Avapro the risk of progression of their nephropathy or death was 20 percent lower than that of the placebo (control) group (p=0.02) and 23 percent lower than the group treated with amlodipine, a calcium-channel blocker (p=0.006).
Taking into account the results of clinical trials such as IDNT, the American Diabetes Association (ADA) issued guidelines that recommend angiotensin II receptor blockers, such as Avapro, as the initial agent of choice in the treatment of high blood pressure patients with type 2 diabetes and evidence of kidney disease.
No adverse events were reported among Avapro-treated patients in IDNT that were not previously reported in Avapro high blood pressure trials. Patients in this study, however, reported orthostatic symptoms (e.g., dizziness and low blood pressure) and increases in serum potassium more often in the Avapro-treated group than the control group. In addition, as soon as pregnancy is detected, patients should discontinue Avapro therapy.
In earlier clinical hypertension trials, there were no significant differences in adverse events between Avapro and placebo. Adverse events that occurred in at least 1 percent of patients treated with Avapro and at a higher rate versus placebo included diarrhea, dyspepsia/heartburn and fatigue.