Holmes D G
Department of Clinical Research, Sandoz Pharma Ltd., Basel, Switzerland.
Am J Hypertens. 1993 Mar;6(3 Pt 2):74S-76S. doi: 10.1093/ajh/6.3.74s.
A total of 190 patients (mean age 57 years; range 21 to 89 years), with a supine diastolic blood pressure (sDBP) of 100 to 120 mm Hg after a 3-week placebo phase, entered a double-blind parallel-group study to receive placebo (n = 62), or slow-release isradipine (SRO) at 2.5 mg (n = 64) or 5 mg (n = 64) once daily for 4 weeks. Blood pressure was always measured between 23.5 and 24.5 h after the previous drug administration. Before and after the 4-week treatment period, blood pressure profiles were recorded from measurements taken immediately before drug administration ('trough') and repeated at 2, 4, 6, and 8 h after administration. A 'peak:trough' ratio was assessed from the data of 156 patients who completed the 4 weeks of active treatment, and for whom blood pressure profiles were available both before and after treatment. A supine DBP of < or = 90 mm Hg at trough was achieved by 28%, 35%, and 47% of patients receiving placebo, 2.5 mg, and 5 mg SRO, respectively. If patients who achieved a reduction in sDBP of at least 10 mm Hg are included, the total response rate becomes 42%, 66%, and 61% in the three treatment groups, respectively. The reduction in sDBP immediately before drug administration (trough effect) was 37% of the 'peak' effect (6 h after administration) with the 2.5-mg dose and 74% with the 5-mg dose. Adverse events were reported by 14.5%, 9.4%, and 17.2% of patients taking placebo and SRO at 2.5 mg and 5 mg, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
在为期3周的安慰剂阶段后,共有190例患者(平均年龄57岁,范围21至89岁),其仰卧位舒张压(sDBP)为100至120 mmHg,进入一项双盲平行组研究,接受安慰剂(n = 62),或每日一次2.5 mg(n = 64)或5 mg(n = 64)的缓释异搏定(SRO)治疗4周。血压总是在前一次给药后23.5至24.5小时之间测量。在4周治疗期前后,记录给药前即刻(“谷值”)以及给药后2、4、6和8小时重复测量的血压情况。根据156例完成4周积极治疗且治疗前后均有血压记录的患者数据评估“峰:谷”比。接受安慰剂、2.5 mg和5 mg SRO治疗的患者中,分别有28%、35%和47%在谷值时仰卧位DBP≤90 mmHg。如果纳入仰卧位DBP降低至少10 mmHg的患者,则三个治疗组的总有效率分别为42%、66%和61%。2.5 mg剂量时,给药前即刻(谷值效应)sDBP的降低为“峰值”效应(给药后6小时)的37%,5 mg剂量时为74%。服用安慰剂、2.5 mg和5 mg SRO的患者中,分别有14.5%、9.4%和17.2%报告了不良事件。(摘要截断于250字)