Efficacy of valsartan in patients aged >= 65 years with systolic hypertension

Objective: This randomized, double-blind, placebo-controlled, parallel-grou p, multicenter trial investigated the effects of valsartan, an angiotensin II receptor blocker, on systolic blood pressure (SBP) in patients aged grea ter than or equal to 65 years with systolic hypertension, with or without d iastolic hypertension. Background: Hypertension in older persons is a public health problem of epi demic proportions. SEP, which increases with age, is a better predictor of cardiovascular morbidity and all-cause mortality than is diastolic blood pr essure (DBP). SEP is now thought to be a major modifiable risk factor for c ardiovascular disease. Methods: The study population consisted of 146 outpatients (74 female and 7 2 male) with a mean (+/- SD) age of 73.0 +/- 6.7 years and a trough mean si tting SEP greater than or equal to 160 mm Hg; 88.4% were white. Patients wi th clinically relevant cardiac valvular disease, documented or suspected re nal 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 match ing 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 SEP, treatment with valsartan was superior to placebo, with reductions of 19.2 mm Hg compared with 8.8 mm Hg, respective ly (P < 0.001, 95% CI -15.7, -5.5). Valsartan also produced superior reduct ions 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 v alsartan was comparable to that of placebo, with adverse events occurring i n 31 (42.5%) valsartan-treated patients compared with 28 (38.4%) patients w ho received placebo. Conclusions: In this patient population of hypertensive patients aged great er than or equal to 65 years, valsartan was effective and well tolerated an d offers a promising new approach to the treatment of systolic hypertension .