FDA Approves Avapro for Treatment of Diabetic Kidney Disease in People With High Blood Pressure

PARIS - September 2002 Bristol-Myers Squibb Company and Sanofi-Synthelabo, Inc. and Paris Bourse announced that the U.S. Food and Drug Administration (FDA) has approved Avapro (R) (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 of Avapro for this new indication marks an important advance in the treatment of patients with high blood pressure, type 2 diabetes and kidney disease," said Edmund Lewis, MD, professor of nephrology and director of the Section of Nephrology at Rush Medical College in Chicago, Illinois. "As a result of this decision physicians now have a new option to help manage this serious condition that affects millions of Americans."

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, published in The New England Journal of Medicine, demonstrated that when these patients were treated with Avapro there was a reduction in the risk of their kidney disease progressing, or death, that was 20 percent lower than the placebo (control) group (p=0.02) and 23 percent lower than the group treated with amlodipine, a calcium-channel blocker (p=0.006).

"As a result of the IDNT trial, we have more data supporting the importance of early treatment of diabetic kidney disease," added Dr. Lewis. "The approval of Avapro means that we now have a new treatment option that can be used to help slow the progression of kidney disease, and delay or avoid the need for dialysis or a kidney transplant."

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Taking into account the results of clinical trials such as IDNT, the American Diabetes Association (ADA) issued guidelines that officially 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 (see boxed WARNING regarding Use in Pregnancy in full prescribing information).

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.

Available for five years, irbesartan is marketed worldwide by Bristol-Myers Squibb and Sanofi-Synthelabo under the brand names of Avapro, AprovelTM, and KarveaTM. Irbesartan is also marketed in combination with hydrochlorothiazide under the brand names Avalide, CoAprovelTM and KarvezideTM. Avapro, discovered by Sanofi-Synthelabo research teams, is part of a co-development and marketing agreement initiated in 1993 between Bristol-Myers Squibb and Sanofi-Synthelabo.

Source: Bristol-Myers Squibb Company