A Zanchetti1, S Omboni. 1. Istituto di Clinica Medica Generale e Terapia Medica and Centro di Fisiologia Clinica e Ipertensione, Ospedale Maggiore di Milano, Università di Milano, Italy.
Abstract
BACKGROUND: The objective of this study was to compare the antihypertensive efficacy and tolerability of candesartan cilexetil (CC) with that of enalapril (E) and placebo (P) in hypertensives by clinic and ambulatory blood pressure (BP). PROCEDURES: The study was an Italian multicenter, randomized, double-blind, parallel group trial including 227 mild to moderate essential hypertensives (age range, 18 to 70 years). After 4 weeks of P, patients were randomized to 8 weeks of treatment with P or CC (4 mg) or E (10 mg) once daily, which was eventually increased to 8 mg and 20 mg once daily in nonresponders. At the end of each study phase, trough BP was measured by conventional sphygmomanometry and ambulatory BP was monitored over 24 h by a Spacelabs device. Analysis of 24-h BP profile included calculation of 24-h, daytime, nighttime, and hourly average values. RESULTS: In the 178 patients evaluable per protocol, at the end of 8 weeks of treatment, trough systolic (S) and diastolic (D) BP were similarly reduced by both active treatments (13 +/- 12 and 10 +/- 7 mm Hg for CC and 14 +/- 12 and 10 +/- 7 mm Hg for E) and significantly more by both treatments than by P (6 +/- 11 and 7 +/- 8 mm Hg, P < .01 v CC and E). In the 85 patients with valid 24-h recordings reduction in 24-h BP was again similar for the two active groups. The antihypertensive effect was still evident during h 23 and 24 after the last dose for both active treatments (8 +/- 20 v 5 +/- 18 mm Hg for SBP and 4 +/- 12 v 6 +/- 13 mm Hg for DBP, CC v E, respectively) but not for P. Heart rate was not significantly modified by either active treatment. The incidence of adverse events was greater in the E than in the CC group. CONCLUSIONS: Our study provides evidence that CC at a dose of 4 to 8 mg is as effective as E at a dose of 10 to 20 mg over 24 h, but is better tolerated than E.
RCT Entities:
BACKGROUND: The objective of this study was to compare the antihypertensive efficacy and tolerability of candesartan cilexetil (CC) with that of enalapril (E) and placebo (P) in hypertensives by clinic and ambulatory blood pressure (BP). PROCEDURES: The study was an Italian multicenter, randomized, double-blind, parallel group trial including 227 mild to moderate essential hypertensives (age range, 18 to 70 years). After 4 weeks of P, patients were randomized to 8 weeks of treatment with P or CC (4 mg) or E (10 mg) once daily, which was eventually increased to 8 mg and 20 mg once daily in nonresponders. At the end of each study phase, trough BP was measured by conventional sphygmomanometry and ambulatory BP was monitored over 24 h by a Spacelabs device. Analysis of 24-h BP profile included calculation of 24-h, daytime, nighttime, and hourly average values. RESULTS: In the 178 patients evaluable per protocol, at the end of 8 weeks of treatment, trough systolic (S) and diastolic (D) BP were similarly reduced by both active treatments (13 +/- 12 and 10 +/- 7 mm Hg for CC and 14 +/- 12 and 10 +/- 7 mm Hg for E) and significantly more by both treatments than by P (6 +/- 11 and 7 +/- 8 mm Hg, P < .01 v CC and E). In the 85 patients with valid 24-h recordings reduction in 24-h BP was again similar for the two active groups. The antihypertensive effect was still evident during h 23 and 24 after the last dose for both active treatments (8 +/- 20 v 5 +/- 18 mm Hg for SBP and 4 +/- 12 v 6 +/- 13 mm Hg for DBP, CC v E, respectively) but not for P. Heart rate was not significantly modified by either active treatment. The incidence of adverse events was greater in the E than in the CC group. CONCLUSIONS: Our study provides evidence that CC at a dose of 4 to 8 mg is as effective as E at a dose of 10 to 20 mg over 24 h, but is better tolerated than E.