Jern S, Hansson L, Scherstén B, Kullman S, Sörensen S, Dahlöf B, Eggertsen R, Sivertsson R
Hypertension Section, University of Göteborg, Sweden.
J Cardiovasc Pharmacol. 1991;18 Suppl 3:S7-8.
This was a double-blind multicenter study to compare the efficacy, tolerability and effects on the quality of life with isradipine and atenolol in the treatment of essential hypertension. Of 588 patients entering the 6-week placebo run-in period, 549 were eligible for randomization to receive either isradipine or atenolol for 8 weeks. If, at the end of this period, diastolic blood pressure (DBP) remained greater than 90 mm Hg, then both agents were given in combination for a further 10 weeks. Tolerability and quality of life were assessed repeatedly during the placebo and active-treatment phases. A subgroup of 30 patients were followed by 24-h ambulatory blood pressure monitoring, and their results are now being analyzed. In another subgroup of 26 patients, maximum exercise capacity, as determined by ergometer bicycle-testing, was measured once during placebo and twice during active treatment. At the end of the 24-week study period, both isradipine and atenolol as monotherapy had produced significant decreases in blood pressure. There were no significant differences overall between the compounds in quality-of-life and side-effect profiles, although there was a relative absence of ankle edema and headache with isradipine. Furthermore, patients receiving isradipine had no change in performance on exercise testing whereas patients on atenolol had a significant decrease (p less than 0.01).
这是一项双盲多中心研究，旨在比较伊拉地平与阿替洛尔治疗原发性高血压时在疗效、耐受性及对生活质量的影响。在进入为期6周的安慰剂导入期的588例患者中，549例符合随机分组条件，可接受伊拉地平或阿替洛尔治疗8周。如果在此期末舒张压（DBP）仍大于90 mmHg，则两种药物联合使用再治疗10周。在安慰剂期和积极治疗期反复评估耐受性和生活质量。30例患者的亚组接受了24小时动态血压监测，其结果正在分析中。在另一个26例患者的亚组中，通过测力计自行车测试确定的最大运动能力，在安慰剂期测量一次，在积极治疗期测量两次。在为期24周的研究期末，伊拉地平和阿替洛尔单药治疗均使血压显著下降。尽管伊拉地平相对较少出现踝部水肿和头痛，但两种药物在生活质量和副作用方面总体无显著差异。此外，接受伊拉地平治疗的患者运动测试表现无变化，而接受阿替洛尔治疗的患者则显著下降（p<0.01）。
