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      Angiotensin II Receptor Blockers Effective, Better Tolerated Than Calcium Channel Blockers in Elderly Patients: Presented at ASH(HYP)

      By Ed Susman

      NEW YORK, NY -- May 21, 2003 -- A treatment strategy based on the use of angiotensin II receptor blockers appears to be as effective as the use of dihydropyridine calcium channel blockers -- but the receptor blocker showed an advantage in tolerability.

      The findings were presented here on May 17th at the 18th Annual Scientific Meeting of the American Society of Hypertension.

      "Valsartan and amlodipine are both highly effective in controlling blood pressure in patients with isolated systolic hypertension," said Dr. Ettore Malacco, MD, professor of internal medicine, University of Milan, Milan, Italy. "However, valsartan offers a significant tolerability advantage as it shows a reduced risk of developing adverse events."

      In discussing the results of the Valsartan in Isolated Systolic Hypertension (Val-Syst) study, Dr. Malacco said that 74.7% of patients on the angiotensin II receptor blocker achieved normalization of systolic blood pressure, as did 73% of patients on amlodipine.

      But 20.2% of the valsartan patients complained of adverse side effects compared with 31.9% of patients taking amlodipine. "The most serious of those side effects," Dr. Malacco said, "was development of edema, experienced by 10 (4.8%) of the valsartan patients and 57 (26.8%) of the amlodipine patients. The difference in edema was highly significant (P<0.001)," he said.

      The trial researchers enrolled 421 patients 60 to 80 years of age (mean age 69) with isolated systolic hypertension that ranged from 160 mm Hg to 220 mm Hg. In the multicenter, double-blind, randomized, parallel-group, 6-month study, 208 patients were given valsartan, and 213 were given amlodipine.

      Patients were begun on 80 mg of valsartan, and were titrated to 160 mg if needed. They were allowed to add a thiazide diuretic if the first titration did not bring systolic pressure to less than 140 mm Hg. The amlodipine patients were begun on 5 mg and were titrated to 10 mg, and then diuretics if needed.

      A total of 25 patients withdrew from the study due to adverse events -- 11 patients (5.3%) in the valsartan group; 14 (6.6%) in the amlodipine group. Gastrointestinal disorders were the primary reason patients discontinued valsartan (5 patients), Dr. Malacco reported. Peripheral edema was the most commonly cited reason for discontinuing amlodipine (9 patients). No patients in the valsartan group withdrew due to peripheral edema.

      The study was supported by Novartis Pharmaceutical Corporation, East Hanover, NJ.


      [Study title: The Efficacy and Safety of Valsartan-Based Versus Amlodipine-Based Treatment in Elderly Patients With Isolated Systolic Hypertension: The Val-Syst Study. Abstract P-244]



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