Comparative effects of candesartan cilexetil and amlodipine inpatients with mild systemic hypertension

The comparative antihypertensive efficacy and tolerability of the angiotens in II receptor blocker candesartan cilexetil and the calcium channel blocke r amlodipine were evaluated in an 8-week, multicenter, double-blind, random ized, parallel-group, forced-titration study in 251 adult patients (45% wom en, 16% black) with mild hypertension (stage 1). Following a 4- to 5-week p lacebo run-in period, patients with sitting diastolic blood pressure (BP) o f 90 to 99 mm Hg received candesartan cilexetil 16 mg (n = 123) or amlodipi ne 5 mg (n = 128) once daily. After 4 weeks of double-blind treatment, pati ents were uptitrated to candesartan cilexetil 32 mg or amlodipine 10 mg onc e daily. There were no significant differences between the candesartan cile xetil and amlodipine regimens for reducing BP; mean systolic BP/diastolic B P reductions were -15.2/-10.2 mm Hg versus -15.4/ -11.3 mm Hg, respectively (p = 0.88/0.25). Overall, 79% of patients on candesartan cilexetil and 87% of those on amlodipine were controlled (diastolic BP <90 mm Hg). A total o f 3.3% of patients on candesartan cilexetil discontinued treatment, compare d with 9.4% of patients on amlodipine, including 2.4% versus 4.7% for adver se events and 0% versus 1.6% for peripheral edema, respectively, Peripheral edema, the prespecified primary tolerability end point, occurred with sign ificantly greater frequency in patients on amlodipine (22.1%; mild 8.7% mod erate 11.8%, severe 1.6%) versus patients on candesartan cilexetil (8.9% mi ld 8.1%, moderate 0.8%) (p = 0.005). Candesartan cilexetil and amlodipine a re both highly effective in controlling BP in patients with mild hypertensi on. Candesartan cilexetil offers a significant tolerability advantage with respect to less risk of developing peripheral edema. (C) 2001 by Excerpta M edica, Inc.