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Title: European Commission Approves Irbesartan (Aprovel/Karvea) for the Treatment of Diabetic Renal Disease

"European Commission Approves Irbesartan (Aprovel/Karvea) for the Treatment of Diabetic Renal Disease"

Irbesartan, First Drug Approved throughout European Union for Patients with High Blood Pressure and Type 2 Diabetic Renal Disease PARIS, FRANCE -- June 27, 2002 -- Bristol-Myers Squibb Company and Sanofi-Synthelabo yesterday announced that the European Commission has approved irbesartan (Aprovel™ /Karvea™ in the European Union for a new indication: the treatment of renal disease in people with hypertension and type 2 diabetes mellitus (as part of a antihypertensive drug regimen). Irbesartan is the first blood pressure lowering drug approved across the European Union for treatment of both early and late stage diabetic renal disease in hypertensive type 2 diabetic patients. Irbesartan, an angiotensin II receptor antagonist (AIIRA) is already indicated for the treatment of essential hypertension. "Today, we enter a new era in the treatment of diabetic kidney disease," said Dr. Luis Ruilope, Professor of Medicine and Chief of the Hypertension Unit at Hospital 12 de Octubre, Madrid, Spain, a European Clinical Coordinator from the IDNT study. "For the first time, we now have an approved treatment - irbesartan - that can slow the progression of kidney disease in people with high blood pressure and type 2 diabetes. Now we have a treatment that is not only an excellent blood pressure lowering agent but that also has the ability to protect the kidneys from damage, above and beyond its effect on blood pressure lowering." This new indication is based on the PRIME (PRogram for Irbesartan Mortality and Morbidity Evaluations) program, consisting of two studies -- IRMA-2 (IRbesartan MicroAlbuminuria Type 2 Diabetes Mellitus in Hypertensive Patients) and IDNT (Irbesartan Diabetic Nephropathy Trial) in people with hypertension and type 2 diabetes. PRIME is the first clinical program to evaluate hypertensive type 2 diabetic patients across the broad spectrum of early (IRMA-2) and late stage (IDNT) kidney disease. "Results from the PRIME study demonstrate that treating type 2 diabetes as early as possible can make a dramatic difference in the resulting illness and death caused from this disease in millions of patients worldwide," said IRMA-2 Principal Investigator, Professor Hans-Henrik Parving, Steno Diabetes Centre, Gentofe, Denmark. He continued, "Physicians now have a valuable new tool in irbesartan which slows the progression of kidney disease, and delays or prevents the need for dialysis or a kidney transplant." The results of IRMA-2 were published in the Sept. 20, 2001 issue of the New England Journal of Medicine. IRMA-2 showed irbesartan reduces the risk of progression of renal disease in hypertensive patients with type 2 diabetes and microalbuminuria, a marker for early stage renal disease. In patients receiving 300 milligrams of irbesartan daily for about two years, the relative risk reduction was 70 percent (P<0.001) for the development of overt proteinuria versus the control group (placebo plus other allowed medications to lower blood pressure). The results of IDNT were also published in the same issue of the New England Journal of Medicine. IDNT demonstrated that irbesartan administered for an average of 2.6 years slows the progression of diabetic nephropathy toward doubling of serum creatinine and end-stage renal disease and its consequences (dialysis, transplantation, death) by 20 percent (P=0.02) versus the control group (placebo plus other allowed medications to lower blood pressure) and by 23 percent (P=0.006) versus amlodipine in hypertensive patients with overt Type 2 diabetic nephropathy. According to the World Health Organization, high blood pressure affects more than 600 million people worldwide and more than 135 million people worldwide have diabetes -- about 80 percent of which also have hypertension. The most common form of diabetes is type 2, representing 85 to 95 percent of all diabetes cases, which is the leading cause of end stage renal disease (worsening kidney disease) which can lead to dialysis or the need for a kidney transplant in these patients. Irbesartan is marketed worldwide by Bristol-Myers Squibb and Sanofi-Synthelabo under the brand names of Avapro(R), Aprovel(TM), and Karvea(TM). Irbesartan is also marketed in combination with hydrochlorothiazide under the brand names Avalide(R), CoAprovel(TM) and Karvezide(TM). Irbesartan, 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. As soon as pregnancy is detected, discontinue irbesartan (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 irbesartan and placebo that occurred in at least 1 percent of patients treated with irbesartan and at a higher rate versus placebo, including: diarrhea (3% vs. 2%), dyspepsia/heartburn (2% vs. 1%), musculoskeletal trauma (2% vs. 1%), fatigue (4% vs. 3%), and upper respiratory infection (9% vs. 6%). For additional information concerning irbesartan, including full prescribing information, please contact Bristol-Myers Squibb Company or Sanofi-Synthelabo. Visit Bristol-Myers Squibb on the World Wide Web at http://www.bms.com Visit Sanofi-Synthelabo on the World Wide Web at http://www.sanofi-synthelabo.com SOURCE: Bristol-Myers Squibb Company; Sanofi-Synthelabo

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