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| |  ADA: Irbesartan Protects Against Kidney Disease Progression In Hypertensive Diabetics PHILADELPHIA, PA -- June 25, 2001 -- Important new study results from a landmark program demonstrate that the angiotensin II receptor blocker, irbesartan, a high blood pressure medication, protected against the progression of kidney disease in people with hypertension and Type 2 diabetes. These results, presented at the 61st Annual Scientific Sessions of the American Diabetes Association in Philadelphia, are part of PRIME, the Program for Irbesartan Mortality and Morbidity Evaluations. PRIME consists of two studies: IRMA 2, IRbesartan MicroAlbuminuria Type 2 and IDNT, Irbesartan Diabetic Nephropathy Trial. In the IRMA 2 trial, 300 mg of irbesartan once daily demonstrated a 70 percent relative risk reduction (p=0.0004) for the progression from early to a later and more serious stage of kidney disease (also called diabetic nephropathy) compared with patients who did not receive irbesartan. Progression to diabetic nephropathy was determined by tracking changes in the amount of albumin (a protein) in patient’s urine. Subsequent analyses show that treating 10 patients with hypertension and Type 2 diabetes with 300 mg of irbesartan daily for two years would prevent one patient from developing more advanced diabetic nephropathy. The IRMA 2 trial was a double-blind, placebo-controlled study conducted in 590 patients with hypertension, Type 2 diabetes and microalbuminuria (early stage kidney disease). "In the IRMA 2 trial, there was a large reduction in the number of patients who progressed to advanced diabetic nephropathy," said principal investigator for IRMA 2, Professor H.-H. Parving from the Steno Diabetes Center in Gentofte, Denmark. In IDNT, irbesartan demonstrated a 20 percent relative risk reduction (p=0.0237) in the primary end point (progression to doubling of serum creatinine, end- stage renal disease or all-cause mortality) versus control (placebo in addition to other antihypertensive therapies). Irbesartan further demonstrated a 23 percent relative risk reduction (p=0.006) in the primary end point versus amlodipine, a calcium channel blocking drug for high blood pressure. Subsequent analyses show that treating 15 patients with hypertension and Type 2 diabetes with irbesartan for three years, compared to not receiving irbesartan therapy, would prevent one patient from worsening kidney function, kidney failure or death. The IDNT trial, a double-blind, placebo-controlled study, was conducted in 1,715 patients with hypertension, Type 2 diabetes and proteinuria (late stage kidney disease). "Based on NHANES III, there are approximately 550,000 patients in the United States alone that fulfill the IDNT inclusion criteria," said Lawrence Hunsicker, MD, Professor of Internal Medicine (Nephrology) at the University of Iowa College of Medicine. "If these patients were treated with irbesartan, an estimated 35,000 cases of end-stage renal disease might be avoided based on the results from IDNT; such a reduction in renal events could be associated with a cost savings to the healthcare system of approximately US $2.5 billion within three years." In both trials, irbesartan exhibited a good safety profile and was generally well tolerated. Patients in all treatment groups of both trials received other non-excluded high blood pressure drugs to help achieve the target blood pressure. According to the International Diabetes Federation, more than 143 million people worldwide have diabetes and the number is expected to rise to almost 300 million by the year 2025. The most common form of diabetes is Type 2, representing about 85-95 percent of all diabetes. Diabetes is the leading cause of kidney disease. PRIME is the first clinical program to show benefit in patients with hypertension and Type 2 diabetes across the spectrum of early and late stage kidney disease. The PRIME program, including the IRMA 2 and IDNT trials, is sponsored by Bristol-Myers Squibb and Sanofi-Synthelabo. Irbesartan is currently indicated for the treatment of hypertension. A supplemental application, based on the PRIME program results, will be filed with worldwide regulatory agencies later this year. As soon as pregnancy is detected, irbesartan is to be discontinued. In clinical 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 percent vs. 2 percent), dyspepsia/heartburn (2 percent vs. 1 percent), musculoskeletal trauma (2 percent vs. 1 percent), fatigue (4 percent vs. 3 percent), and upper respiratory infection (9 percent vs. 6 percent). Irbesartan is marketed worldwide by Bristol-Myers Squibb and Sanofi-Synthelabo under the brand names of Aprovel™, Avapro® and Karvea™. Irbesartan is also marketed in combination with hydrochlorothiazide under the brand names CoAprovel™, Avalide® and Karvezide™. Irbesartan is part of a co-development and marketing agreement initiated in 1993 between Bristol- Myers Squibb and Sanofi-Synthelabo. SOURCE: Bristol-Myers Squibb Company; Sanofi-Synthelabo
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