EFFECTS OF CANDESARTAN CILEXETIL IN PATIENTS WITH SYSTEMIC HYPERTENSION

The objectives of this double-blind, multicenter, randomized, parallel -arm, placebo-controlled study were to evaluate the dose-related effic acy, tolerability, and safety of candesartan cilexetil, a potent, AT(1 ) selective, long-acting angiotensin II receptor blocker, in 365 adult patients with systemic hypertension and mean sitting diastolic blood pressure (BP) of 95 to 114 mm Hg. patients received either placebo or candesartan cilexetil 2, 4, 8, 16, or 32 mg once daily for 8 weeks. Al l doses of candesartan cilexetil reduced trough (24 hours after treatm ent) sitting diastolic and systolic BP significantly compared with pla cebo (p <0.005). A significant (p less than or equal to 0.0001) dose r esponse was evident, with greater decreases in BP at higher doses. Mea n changes in BP were -10.7/-7.8 mm Hg and -12.6/-10.2 mm Hg in the 16- and 32-mg groups, respectively, versus -0.3/-2.6 mm Hg in the placebo group. The 16- and 32-mg doses were consistently significantly superi or to placebo in antihypertensive effect with regard to all BP measure ments, including peak (6 hours after treatment), trough, sitting, and standing measurements of diastolic and systolic BP. Responder rates (t rough sitting diastolic BP <90 or greater than or equal to 10 mm Hg BP decrease) were 54% and 64% for the 16- and 32-mg groups, respectively . Tolerability and safety profiles were similar to placebo at all dose s. In conclusion, candesartan cilexetil administered once daily effect ively reduces BP in a dose-related manner while maintaining safety and tolerability; doses of 16- and 32 mg are most effective for treatment of hypertension. (C) 1998 by Excerpta Medica, Inc.