Bellet M, Loria Y, Lallemand A
J Cardiovasc Pharmacol. 1985 Nov-Dec;7(6):1149-53. doi: 10.1097/00005344-198511000-00021.
Nicardipine, a new calcium antagonist, was tested in a 14-week double-blind trial including 15 outpatients with uncomplicated essential hypertension. They were randomly assigned to nicardipine (20-30 mg three times daily) or placebo as first-step treatment. When necessary but always after a minimum of 4 weeks, pindolol (15 mg/day) was combined with nicardipine or placebo. At the end of step 1 (85 +/- 6 days with nicardipine vs. 58 +/- 6 days with placebo, p less than 0.01), nicardipine induced larger drops in supine systolic and diastolic blood pressure (SBP and DBP) than the placebo (21 +/- 2.5 vs 1.4 +/- 3 mm Hg, p less than 0.001, and 13 +/- 2 vs. 3.5 +/- 1.5 mm Hg, p less than 0.001, respectively). In the nicardipine group (n = 57), 53% of patients had controlled blood pressure (SBP less than 160 mm Hg and DBP less than 95 mm Hg) versus 17% in the placebo group (n = 47), p less than 0.001. There was no significant correlation between the decrease in blood pressure and the age of patients. The most common side effects in the nicardipine group were flushes (12%), headache (8%), ankle edema (5%), and asthenia (4%). When blood pressure was not brought under control and pindolol was prescribed as the second-step treatment, the nicardipine group (n = 52) displayed larger drops in SBP and DBP than the placebo group (n = 40) (27 +/- 5 vs. 15 +/- 3 mm Hg, p less than 0.01, and 18 +/- 1 vs. 9 +/- 2 mm Hg, p less than 0.001, respectively). These results show that a calcium antagonist is useful for first-step treatment of hypertension.
新型钙拮抗剂尼卡地平在一项为期14周的双盲试验中进行了测试,该试验纳入了15例无并发症的原发性高血压门诊患者。他们被随机分配接受尼卡地平(每日3次,每次20 - 30毫克)或安慰剂作为初始治疗。必要时且至少在4周后,将吲哚洛尔(15毫克/天)与尼卡地平或安慰剂联合使用。在第一步治疗结束时(尼卡地平组为85±6天,安慰剂组为58±6天,p<0.01),尼卡地平使仰卧位收缩压和舒张压(SBP和DBP)下降幅度大于安慰剂(分别为21±2.5对1.4±3毫米汞柱,p<0.001;13±2对3.5±1.5毫米汞柱,p<0.001)。在尼卡地平组(n = 57)中,53%的患者血压得到控制(SBP<160毫米汞柱且DBP<95毫米汞柱),而安慰剂组(n = 47)为17%,p<0.001。血压下降与患者年龄之间无显著相关性。尼卡地平组最常见的副作用为面部潮红(12%)、头痛(8%)、踝部水肿(5%)和乏力(4%)。当血压未得到控制且将吲哚洛尔作为第二步治疗药物时,尼卡地平组(n = 52)的SBP和DBP下降幅度大于安慰剂组(n = 40)(分别为27±5对15±3毫米汞柱,p<0.01;18±1对9±2毫米汞柱,p<0.001)。这些结果表明,钙拮抗剂对高血压的初始治疗有用。