Wolfson P, Abernethy D, DiPette D J, Zusman R
Chicago Osteopathic Medical Center, Illinois 60615.
Am J Cardiol. 1988 Oct 5;62(11):103G-108G. doi: 10.1016/0002-9149(88)90041-0.
The efficacy and safety of sustained-release diltiazem, 60 to 180 mg twice daily, was compared with that of captopril, 25 to 75 mg twice daily, alone and in combination, in 132 patients with mild to moderate essential hypertension (supine diastolic blood pressure [BP] 95 to 114 mm Hg). All patients received placebo for 4 to 6 weeks, followed by randomization to diltiazem or captopril during the double-blind monotherapy phase. Either study drug was titrated over 6 weeks to achieve a goal supine diastolic BP reduction of at least 10 mm Hg and a diastolic BP of less than 90 mm Hg. Patients achieving the goal BP reduction were maintained on monotherapy for an additional 8 weeks. Patients not achieving the treatment goal after 8 weeks with either drug alone received the other drug in combination, titrated to achieve goal BP response. Both drugs lowered BP significantly and, at the doses used, diltiazem had a greater effect on diastolic BP than did captopril. The mean changes from baseline at week 8 were -10.6 and -7.3 mm Hg, respectively, (p = 0.01). Goal BP was achieved in 38% of patients taking diltiazem monotherapy and in 34% of patients taking captopril monotherapy. There were no significant differences between diltiazem and captopril in diastolic or systolic BP reductions by race or age. The addition of alternate therapy for non-goal achievers at week 8 resulted in significant reductions in diastolic and systolic BP by week 16.(ABSTRACT TRUNCATED AT 250 WORDS)
将60至180毫克缓释地尔硫䓬每日两次的疗效和安全性,与25至75毫克卡托普利每日两次单独使用及联合使用的疗效和安全性进行比较,研究对象为132例轻度至中度原发性高血压患者(仰卧位舒张压[BP]95至114毫米汞柱)。所有患者接受4至6周的安慰剂治疗,随后在双盲单药治疗阶段随机分为地尔硫䓬组或卡托普利组。两种研究药物均在6周内滴定,以实现仰卧位舒张压至少降低10毫米汞柱且舒张压低于90毫米汞柱的目标。达到目标血压降低的患者继续单药治疗8周。单独使用任一药物8周后未达到治疗目标的患者接受另一种药物联合治疗,并滴定至达到目标血压反应。两种药物均能显著降低血压,且在所使用的剂量下,地尔硫䓬对舒张压的影响大于卡托普利。第8周时与基线相比的平均变化分别为-10.6和-7.3毫米汞柱(p = 0.01)。38%接受地尔硫䓬单药治疗的患者和34%接受卡托普利单药治疗的患者达到了目标血压。地尔硫䓬和卡托普利在按种族或年龄降低舒张压或收缩压方面无显著差异。在第8周对未达到目标者加用替代疗法,到第16周时舒张压和收缩压显著降低。(摘要截短至250字)