Nugent L W, Miola S R, Walker J F
Merck, Sharp & Dohme Research Laboratories, West Point, PA 19486.
J Clin Pharmacol. 1987 Jul;27(7):461-7. doi: 10.1002/j.1552-4604.1987.tb03050.x.
The safety and efficacy of step-one therapy with enalapril, a new angiotensin-converting enzyme inhibitor, and metoprolol were compared in a double-blind, multicenter study involving 150 patients who had mild to moderate essential hypertension. After a four-week period of placebo run-in, therapy was initiated with twice-daily administration of either 5 mg of enalapril (N = 75) or 50 mg of metoprolol (N = 75). Patients who did not achieve a supine diastolic blood pressure of less than 90 mm Hg after six weeks of enalapril (maximum dose = 40 mg/d) or metoprolol (maximum dose = 400 mg/d) had hydrochlorothiazide 50 mg/d added to their treatment regimen for an additional six weeks. Both treatments produced significant (P less than .001) mean reductions in supine and standing blood pressures after 2, 4, 6, 8, 10, and 12 weeks of active therapy. Maximum reductions from baseline values of supine blood pressure in enalapril-treated (-25/-16 mm Hg) and metoprolol-treated (-21/-15 mm Hg) patients were observed after 12 weeks of single- or double-drug therapy. Approximately two-thirds of the patients responded to single-drug therapy; when hydrochlorothiazide was added, response rates increased to 88% of the patients treated with enalapril and 80% of the patients treated with metoprolol. Enalapril produced a consistently greater reduction in systolic blood pressure. Blacks had a significantly smaller mean blood pressure response to both enalapril and metoprolol than did nonblacks. Metoprolol patients had significant mean pulse rate reductions; enalapril patients had no significant change. Four enalapril-treated and six metoprolol-treated patients discontinued treatment because of side effects.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项双盲、多中心研究中,对150例轻至中度原发性高血压患者比较了新型血管紧张素转换酶抑制剂依那普利与美托洛尔的一步疗法的安全性和有效性。经过为期四周的安慰剂导入期后,开始治疗,每日两次给予5毫克依那普利(N = 75)或50毫克美托洛尔(N = 75)。在接受依那普利(最大剂量 = 40毫克/天)或美托洛尔(最大剂量 = 400毫克/天)治疗六周后,仰卧舒张压未降至90毫米汞柱以下的患者,在其治疗方案中加用50毫克/天的氢氯噻嗪,再治疗六周。两种治疗在积极治疗2、4、6、8、10和12周后,仰卧位和站立位血压均有显著(P小于0.001)的平均降低。在单药或双药治疗12周后,观察到依那普利治疗组(-25 / -16毫米汞柱)和美托洛尔治疗组(-21 / -15毫米汞柱)患者仰卧位血压相对于基线值的最大降幅。约三分之二的患者对单药治疗有反应;加用氢氯噻嗪后,依那普利治疗患者的反应率增至88%,美托洛尔治疗患者的反应率增至80%。依那普利使收缩压持续降低幅度更大。黑人对依那普利和美托洛尔的平均血压反应均显著小于非黑人。美托洛尔治疗患者的平均脉搏率显著降低;依那普利治疗患者无显著变化。4例接受依那普利治疗和6例接受美托洛尔治疗的患者因副作用而停药。(摘要截短于250字)