BACKGROUND: Twenty-four-hour ambulatory blood pressure monitoring (ABPM) provides the most accurate efficacy assessment of an antihypertensive agent throughout a 24-hour dosing interval. The objective of this prospective, randomised, double-blind, parallel-group, multicentre study was to compare the antihypertensive efficacy of imidapril versus candesartan cilexetil using ABPM. METHODS: After screening and a single-blind, placebo run-in phase, ambulatory adult patients with mild to moderate hypertension (defined as a mean office sitting diastolic BP [DBP] and systolic BP [SBP], respectively, of 90-109 mm Hg and 140-179 mm Hg, and a mean ABPM DBP and SBP, respectively, of >or=80 mm Hg and >or=125 mm Hg) were randomised to once-daily treatment with imidapril or candesartan cilexetil for 12 weeks. ABPM was performed at baseline and at the end of the 12-week treatment period in 112 patients (imidapril group, n=55; candesartan cilexetil group, n=57). To achieve the target BP of <or=140/90 mm Hg, imidapril was titrated from 5 mg/day to 20 mg/day and candesartan cilexetil was titrated from 4 mg/day to 16 mg/day. RESULTS: Significant (p<0.001) and similar decreases from baseline in clinic mean DBP and SBP, in mean 24-hour ABPM, DBP and SBP awake and asleep, and in mean BP (MBP) were observed in both treatment groups. In addition, significant and similar reductions in DBP and SBP were observed during the early morning acceleration period in both treatments. The reduction in BP load was higher with imidapril than with candesartan cilexetil: 44.6% versus 34.5% reduction in DBP load and 38.0% versus 32.9% reduction in SBP load, respectively. With respect to the average deviation index expressing a load index, the reduction with imidapril was 41.0% versus 33.6% with candesartan cilexetil. The percentage of DBP dipper patients remained identical before and after treatment in both groups. With regard to SBP, the percentage of dippers increased from 38.2% to 45.5% in the imidapril group and decreased from 54.4% to 42.1% in the candesartan cilexetil group. The incidence of adverse events was similar between the treatment groups and no cases of dry cough were reported. CONCLUSION:Imidapril in once-daily doses of up to 20mg was shown to be at least as effective as candesartan cilexetil given in once-daily doses of up to 16 mg in reducing BP throughout the entire 24-hour dosing interval. Both drugs were well tolerated.
RCT Entities:
BACKGROUND: Twenty-four-hour ambulatory blood pressure monitoring (ABPM) provides the most accurate efficacy assessment of an antihypertensive agent throughout a 24-hour dosing interval. The objective of this prospective, randomised, double-blind, parallel-group, multicentre study was to compare the antihypertensive efficacy of imidapril versus candesartan cilexetil using ABPM. METHODS: After screening and a single-blind, placebo run-in phase, ambulatory adult patients with mild to moderate hypertension (defined as a mean office sitting diastolic BP [DBP] and systolic BP [SBP], respectively, of 90-109 mm Hg and 140-179 mm Hg, and a mean ABPM DBP and SBP, respectively, of >or=80 mm Hg and >or=125 mm Hg) were randomised to once-daily treatment with imidapril or candesartan cilexetil for 12 weeks. ABPM was performed at baseline and at the end of the 12-week treatment period in 112 patients (imidapril group, n=55; candesartan cilexetil group, n=57). To achieve the target BP of <or=140/90 mm Hg, imidapril was titrated from 5 mg/day to 20 mg/day and candesartan cilexetil was titrated from 4 mg/day to 16 mg/day. RESULTS: Significant (p<0.001) and similar decreases from baseline in clinic mean DBP and SBP, in mean 24-hour ABPM, DBP and SBP awake and asleep, and in mean BP (MBP) were observed in both treatment groups. In addition, significant and similar reductions in DBP and SBP were observed during the early morning acceleration period in both treatments. The reduction in BP load was higher with imidapril than with candesartan cilexetil: 44.6% versus 34.5% reduction in DBP load and 38.0% versus 32.9% reduction in SBP load, respectively. With respect to the average deviation index expressing a load index, the reduction with imidapril was 41.0% versus 33.6% with candesartan cilexetil. The percentage of DBP dipperpatients remained identical before and after treatment in both groups. With regard to SBP, the percentage of dippers increased from 38.2% to 45.5% in the imidapril group and decreased from 54.4% to 42.1% in the candesartan cilexetil group. The incidence of adverse events was similar between the treatment groups and no cases of dry cough were reported. CONCLUSION:Imidapril in once-daily doses of up to 20mg was shown to be at least as effective as candesartan cilexetil given in once-daily doses of up to 16 mg in reducing BP throughout the entire 24-hour dosing interval. Both drugs were well tolerated.
Authors: F Gueyffier; C Cornu; N Bossard; C Mercier; P Poncelet; A Sebaoun; G Jullien; C Aviérinos; J Y Fraboulet; J P Boissel Journal: Arch Mal Coeur Vaiss Date: 1999-08