Mulinari R, Gavras I, Gavras H
Department of Medicine, Boston City Hospital, Massachusetts.
Clin Ther. 1987;9(6):678-89.
In an eight-week, multicenter open-label study of enalapril monotherapy for mild-to-moderate essential hypertension, data for 115 of the 276 participants between the ages of 55 and 75 years (whites, n = 90; blacks, n = 25) were analyzed. These data were compared with similar data for the study subset of 92 younger patients between the ages of 21 and 45 years (whites, n = 58; blacks, n = 34). The most striking finding was the overall lack of significant differences in response between older and younger patients. There were, however, significant differences in response to therapy between the two racial groups studied. In the older group, normotension was achieved in 66% of white patients and 60% of black patients with a single daily dose of enalapril ranging from 5 to 40 mg; the group means, 13 +/- 1 mg in whites vs 22 +/- 2 mg in blacks, differed significantly (P less than 0.05). Thirty-one percent of older white patients attained normotension with a daily dosage of 5 mg, whereas only 4% of black patients in this age group did so. Only 4% of the older white patients but 24% of the older black patients reached the highest recommended daily dosage of 40 mg of enalapril. Adverse reactions occurred in 11% of the older white patients and 16% of the older black patients (a nonsignificant difference), consisting mostly of gastrointestinal discomfort, malaise, dizziness, and pruritus. There were no significant biochemical abnormalities, the only consistent change being a slight increase in mean plasma potassium from 4.34 to 4.45 mEq/L in older whites (P less than 0.05). Enalapril appeared to be generally effective and well tolerated in the management of mild-to-moderate hypertension in the older subset of patients in this study. Efficacy and tolerability data for older and younger patients were comparable.
在一项为期八周的多中心开放标签研究中,使用依那普利单药治疗轻度至中度原发性高血压,分析了276名年龄在55至75岁之间的参与者中的115名(白人90名,黑人25名)的数据。将这些数据与年龄在21至45岁之间的92名年轻患者研究子集的类似数据进行比较(白人58名,黑人34名)。最显著的发现是老年患者和年轻患者之间总体反应缺乏显著差异。然而,在研究的两个种族群体之间,对治疗的反应存在显著差异。在老年组中,66%的白人患者和60%的黑人患者通过每日一次服用5至40毫克依那普利实现了血压正常;两组平均值,白人13±1毫克,黑人22±2毫克,差异显著(P<0.05)。31%的老年白人患者通过每日5毫克的剂量达到血压正常,而该年龄组中只有4%的黑人患者如此。只有4%的老年白人患者但24%的老年黑人患者达到了依那普利每日最高推荐剂量40毫克。11%的老年白人患者和16%的老年黑人患者出现不良反应(无显著差异),主要包括胃肠道不适、不适、头晕和瘙痒。没有显著的生化异常,唯一持续的变化是老年白人的平均血浆钾从4.34毫当量/升略有增加至4.45毫当量/升(P<0.05)。在本研究中,依那普利在老年患者亚组中治疗轻度至中度高血压方面似乎总体有效且耐受性良好。老年患者和年轻患者的疗效和耐受性数据具有可比性。