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ESC: Irbesartan Protects Against Kidney Disease Progression in Hypertension, Type 2 Diabetes BOSTON, MA -- September 4, 2001 -- The high blood pressure medication irbesartan protects against or slows the progression of kidney disease and death from any cause in people with hypertension and Type 2 diabetes, according to a new analysis of the results from an international study, the Irbesartan Diabetic Nephropathy Trial (IDNT), presented today at the 23rd Congress of the European Society of Cardiology in Stockholm, Sweden. The purpose of IDNT was to assess the effects of the angiotensin II receptor antagonist (AIIRA) irbesartan versus the calcium channel blocker (CCB) amlodipine and a control group of other proven antihypertensive treatments (excluding angiotensin converting enzyme [ACE] inhibitors, other AIIRAs, and other CCBs) on the progression of kidney disease and total mortality in patients in the late stages of diabetic kidney disease. A secondary endpoint of the trial was to compare the impact of the three treatment regimens on cardiovascular endpoints. In addition, an analysis looking at the morbidity and mortality events for these patients (i.e., renal, cardiovascular, or death outcomes) was also conducted. As previously reported at the most recent annual meetings of the American Society of Hypertension and European Society of Hypertension, patients taking irbesartan had a significant (20 percent) risk reduction in the progression of kidney disease or death from any cause when compared to the control group and a 23 percent risk reduction when compared to those taking amlodipine. Progression of kidney disease was defined as doubling of baseline serum creatinine (a sign of worsening kidney disease) or end stage renal disease (ESRD, defined as renal transplantation or the initiation of dialysis). "While blood pressure lowering was comparable in all groups, irbesartan demonstrated a significantly greater benefit in reducing important renal events," said Marc A. Pfeffer, M.D., Ph.D., Professor of Medicine, Harvard Medical School, Cardiologist, Brigham and Women's Hospital, and member of the IDNT Collaborative Study Group Executive Committee. "These results underscore a protective effect by irbesartan on renal function." Overall, all three treatment regimens had a similar influence on combined cardiovascular outcomes. The use of irbesartan delayed the time to major cardiovascular or renal events in patients with hypertension and Type 2 diabetes. The analysis of the combined morbidity and mortality events for both renal and cardiovascular endpoints showed a significant 16 percent risk reduction in favor of irbesartan compared with both the amlodipine and control groups. "Patients with diabetes and hypertension with renal impairment are at a very high risk for both major cardiovascular and renal adverse events," said Dr. Pfeffer. "Even at this advanced stage, therapy with irbesartan was particularly effective in postponing the time before major life threatening complications occurred. These benefits appear to be beyond just the blood pressure lowering afforded by irbesartan." The IDNT was a randomized, double-blind trial performed in 210 centers in 20 countries. The study, led by Edmund J. Lewis, M.D., director of nephrology at Rush-Presbyterian-St. Luke's Medical Center in Chicago, included 1,715 men and women between the ages of 30 and 70 years with hypertension, Type 2 diabetes and nephropathy. Patients were randomized to receive irbesartan 300 mg/day, amlodipine 10 mg/day or control (antihypertensive medication for blood pressure control, not including ACE inhibitors, other AIIRAs or calcium channel blockers) and observed for an average of 2.6 years. Hypertension was defined as seated blood pressure of greater than 135/85 mmHg or documented treatment with antihypertensive medications. Patients also had to have 24 hour protein excretion of greater than or equal to 900 mg to be enrolled in the study. IDNT is part of the comprehensive PRIME (PRogram for Irbesartan Mortality and Morbidity Evaluations) program, which also includes the IRbesartan MicroAlbuminuria Type 2 Diabetes Mellitus in Hypertensive Patients (IRMA 2) trial. The PRIME program investigates the use of irbesartan in hypertensive, Type 2 diabetic patients with early and late stage kidney disease. SOURCE: Brigham and Women's Hospital E-mail this page to a friend or colleague! To print, use this version