OBJECTIVE: This randomized, double-blind, placebo-controlled, parallel-group, multicenter trial investigated the effects of valsartan, an angiotensin II receptor blocker, on systolic blood pressure (SBP) in patients aged > or =65 years with systolic hypertension, with or without diastolic hypertension. BACKGROUND: Hypertension in older persons is a public health problem of epidemic proportions. SBP, which increases with age, is a better predictor of cardiovascular morbidity and all-cause mortality than is diastolic blood pressure (DBP). SBP is now thought to be a major modifiable risk factor for cardiovascular disease. METHODS: The study population consisted of 146 outpatients (74 female and 72 male) with a mean (+/- SD) age of 73.0+/-6.7 years and a trough mean sitting SBP > or =160 mm Hg; 88.4% were white. Patients with clinically relevant cardiac valvular disease, documented or suspected renal artery stenosis, and a serum creatinine level >2.5 mg/dL were excluded from the study. After a 2- to 4-week, single-blind, placebo run-in period, patients were randomly assigned to receive valsartan 80 mg or placebo once daily for 4 weeks and were then force-titrated to valsartan 160 mg or matching placebo once daily for an additional 4 weeks. Median DBP was 90 mm Hg, and >50% of the patients had isolated systolic hypertension. RESULTS: For the primary efficacy variable, the change from baseline to end point in trough mean sitting SBP, treatment with valsartan was superior to placebo, with reductions of 19.2 mm Hg compared with 8.8 mm Hg, respectively (P < 0.001, 95% CI -15.7, -5.5). Valsartan also produced superior reductions in trough mean sitting DBP (5.2 mm Hg and 1.2 mm Hg for valsartan and placebo, respectively; P < 0.001, 95% CI -6.4, -2.3). The tolerability of valsartan was comparable to that of placebo, with adverse events occurring in 31 (42.5%) valsartan-treated patients compared with 28 (38.4%) patients who received placebo. CONCLUSIONS: In this patient population of hypertensive patients aged > or =65 years, valsartan was effective and well tolerated and offers a promising new approach to the treatment of systolic hypertension.
RCT Entities:
OBJECTIVE: This randomized, double-blind, placebo-controlled, parallel-group, multicenter trial investigated the effects of valsartan, an angiotensin II receptor blocker, on systolic blood pressure (SBP) in patients aged > or =65 years with systolic hypertension, with or without diastolic hypertension. BACKGROUND:Hypertension in older persons is a public health problem of epidemic proportions. SBP, which increases with age, is a better predictor of cardiovascular morbidity and all-cause mortality than is diastolic blood pressure (DBP). SBP is now thought to be a major modifiable risk factor for cardiovascular disease. METHODS: The study population consisted of 146 outpatients (74 female and 72 male) with a mean (+/- SD) age of 73.0+/-6.7 years and a trough mean sitting SBP > or =160 mm Hg; 88.4% were white. Patients with clinically relevant cardiac valvular disease, documented or suspected renal artery stenosis, and a serum creatinine level >2.5 mg/dL were excluded from the study. After a 2- to 4-week, single-blind, placebo run-in period, patients were randomly assigned to receive valsartan 80 mg or placebo once daily for 4 weeks and were then force-titrated to valsartan 160 mg or matching placebo once daily for an additional 4 weeks. Median DBP was 90 mm Hg, and >50% of the patients had isolated systolic hypertension. RESULTS: For the primary efficacy variable, the change from baseline to end point in trough mean sitting SBP, treatment with valsartan was superior to placebo, with reductions of 19.2 mm Hg compared with 8.8 mm Hg, respectively (P < 0.001, 95% CI -15.7, -5.5). Valsartan also produced superior reductions in trough mean sitting DBP (5.2 mm Hg and 1.2 mm Hg for valsartan and placebo, respectively; P < 0.001, 95% CI -6.4, -2.3). The tolerability of valsartan was comparable to that of placebo, with adverse events occurring in 31 (42.5%) valsartan-treated patients compared with 28 (38.4%) patients who received placebo. CONCLUSIONS: In this patient population of hypertensivepatients aged > or =65 years, valsartan was effective and well tolerated and offers a promising new approach to the treatment of systolic hypertension.