Palma-Gamiz José L, Pêgo Mariano, Marquez Emilio, Pujol Montserrat, Olivan Josefina, Alegría Eduardo, Sagastagoitia-Gorostiza José Domingo, Gonzalez-Juanatey José Ramón
Department of Cardiology, Hospital Ramón y Cajal, Madrid, Spain.
Clin Drug Investig. 2007;27(6):407-17. doi: 10.2165/00044011-200727060-00004.
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.
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.
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.
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.
24小时动态血压监测（ABPM）能在24小时给药间隔内对降压药物的疗效进行最准确的评估。本前瞻性、随机、双盲、平行组、多中心研究的目的是通过ABPM比较咪达普利与坎地沙坦酯的降压疗效。
经过筛选和单盲、安慰剂导入期后，轻度至中度高血压门诊成年患者（定义为诊室坐位舒张压[DBP]和收缩压[SBP]均值分别为90 - 109 mmHg和140 - 179 mmHg，24小时动态血压监测DBP和SBP均值分别≥80 mmHg和≥125 mmHg）被随机分为每日一次服用咪达普利或坎地沙坦酯治疗12周。112例患者（咪达普利组，n = 55；坎地沙坦酯组，n = 57）在基线和12周治疗期结束时进行ABPM。为达到目标血压≤140/90 mmHg，咪达普利从5 mg/天滴定至20 mg/天，坎地沙坦酯从4 mg/天滴定至16 mg/天。
两个治疗组在诊室平均DBP和SBP、24小时平均ABPM、清醒和睡眠时的DBP和SBP以及平均血压（MBP）较基线均有显著（p < 0.001）且相似的下降。此外，两种治疗在清晨血压加速期DBP和SBP均有显著且相似的降低。咪达普利的血压负荷降低幅度高于坎地沙坦酯：DBP负荷降低分别为44.6%和34.5%，SBP负荷降低分别为38.0%和32.9%。关于表示负荷指数的平均偏差指数，咪达普利的降低幅度为41.0%，坎地沙坦酯为33.6%。两组治疗前后DBP杓型患者百分比保持不变。关于SBP，咪达普利组杓型患者百分比从38.2%增至45.5%，坎地沙坦酯组从54.4%降至42.1%。治疗组间不良事件发生率相似，未报告干咳病例。
每日一次服用高达20mg的咪达普利在整个24小时给药间隔内降压效果至少与每日一次服用高达16mg的坎地沙坦酯相当。两种药物耐受性均良好。
