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ASH: Norvasc (Amlodipine Besylate) Valuable For Treating High Blood Pressure in Diabetics NEW YORK, NY -- May 22, 2001 -- Pfizer Inc said today that results from a major new study further demonstrate the value of its calcium channel blocker Norvasc (amlodipine besylate) in treating high blood pressure in patients with diabetes and severe renal disease. In the landmark Irbesartan in Diabetic Nephropathy Trial (IDNT), initiated by the Collaborative Study Group, 1,715 patients received either placebo, an Angiotensin II Receptor Blocker (ARB), Avapro (irbesartan) or Norvasc. Patients also received additional medications -- except other ARBs or Angiotensin Converting Enzyme Inhibitors (ACE-Is) -- to further reduce blood pressure to goal if necessary. The patients assigned to the placebo group were mainly treated with diuretics and beta-blockers. "These new data dispel the notion that in diabetic patients with high blood pressure, calcium channel blockers like Norvasc might not be as effective as diuretics, beta-blockers or ARBs in preventing the cardiovascular complications of hypertension," said Dr. Murray Epstein, Professor of Medicine, Renal Division, University of Miami School of Medicine. The study's primary objective was to determine the effects of these treatments on the progression of renal disease. As expected, irbesartan was shown to slow the progression of renal disease. The effects of treatment on cardiovascular complications such as heart attacks and stroke also were examined, as diabetics are two to four times more likely to have heart disease or suffer from stroke than non-diabetics. "Therapy with multiple medications is indispensable to bring blood pressure to goal in the vast majority of these difficult-to-treat patients. The IDNT results clearly support the use of Norvasc to reach these goals," said Dr. Hubert Pouleur, Pfizer's Senior Medical Director, Cardiovascular Group. "Patients with diabetic nephropathy are fragile," Dr. Pouleur said. "ARBs or ACE-Is alone rarely bring blood pressure down to levels recommended in these patients, and often we have to use two or even three drugs to reach goal levels." In the IDNT study, which was sponsored by Bristol-Myers Squibb/Sanofi, Norvasc was shown to be effective in helping to lower blood pressure in renal patients. Cardiovascular complications of high blood pressure such as death, heart attack, stroke, congestive heart failure and amputation were similar in patients taking Norvasc (23 percent), irbesartan (24 percent) or traditional medications (25 percent) such as beta-blockers or diuretics. ARBs and ACE-Is share some mechanisms of action, and many clinical investigators believe both ACE-Is and ARBs provide direct vascular and cardiac protection. "What we can say is that amlodipine appeared to be safe and effective in lowering blood pressure in these patients," said Dr. Edmund Lewis, principal investigator of IDNT and Director of Nephrology at Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, at a press conference Saturday during the American Society of Hypertension annual meeting, where the results were presented. The ability of Norvasc to reduce the risk of the long-term complications of high blood pressure is being studied in over 43,000 patients in the National Institutes of Health ALLHAT trial, which is the largest study ever undertaken in hypertension. In clinical trials, the most common side effects for Norvasc versus placebo were edema (8.3 percent vs. 2.4 percent), headache (7.3 percent vs. 7.8 percent), fatigue (4.5 percent vs. 2.8 percent) and dizziness (3.2 percent vs. 3.4 percent). SOURCE: Pfizer Inc. Related Link: Pfizer Inc. E-mail this page to a friend or colleague! To print, use this version