Forette F, Bellet M, Henry J F, Hervy M P, Poyard-Salmeron C, Bouchacourt P, Guerret M
Br J Clin Pharmacol. 1985;20 Suppl 1(Suppl 1):125S-129S. doi: 10.1111/j.1365-2125.1985.tb05154.x.
The purpose of this study was to test tolerance and the antihypertensive effect of nicardipine, a new calcium antagonist, in 31 elderly patients aged 57-95 years. The study was conducted as a double-blind trial. The patients were allocated randomly to either active or placebo treatment. Sixteen patients were given 10-30 mg of nicardipine three times a day (mean dose, 69.4 mg per day); 15 other patients received a matching placebo. After 4 weeks, nicardipine lowered mean blood pressure, and the changes in systolic and diastolic blood pressure were significantly greater in the nicardipine group than in the placebo group. Nicardipine was tolerated very well, and orthostatic hypotension was never observed. There was no change in heart rate. Plasma renin activity (PRA) was measured in eight patients. There was no correlation between PRA and the antihypertensive effect of nicardipine. A pharmacokinetic study performed in 15 elderly patients showed a fast rate of absorption and also higher plasma levels than those observed in hypertensive adults (mean age, 54 years). This trial demonstrates the effectiveness of nicardipine in elderly hypertensive patients.
本研究旨在测试新型钙拮抗剂尼卡地平对31名年龄在57至95岁之间的老年患者的耐受性及降压效果。该研究以双盲试验方式进行。患者被随机分配接受活性药物或安慰剂治疗。16名患者每日三次服用10 - 30毫克尼卡地平(平均剂量为每日69.4毫克);另外15名患者接受匹配的安慰剂。4周后,尼卡地平降低了平均血压,且尼卡地平组收缩压和舒张压的变化显著大于安慰剂组。尼卡地平耐受性良好,从未观察到体位性低血压。心率无变化。对8名患者测量了血浆肾素活性(PRA)。PRA与尼卡地平的降压效果之间无相关性。对15名老年患者进行的药代动力学研究显示,其吸收速度快,且血浆水平高于高血压成年患者(平均年龄54岁)。该试验证明了尼卡地平在老年高血压患者中的有效性。