Hall W D, Reed J W, Flack J M, Yunis C, Preisser J
Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
Arch Intern Med. 1998 Oct 12;158(18):2029-34. doi: 10.1001/archinte.158.18.2029.
Hypertension is a prevalent disease among African Americans, and successful treatment rates are low. Since calcium channel blockers are well-tolerated and efficacious in African Americans, we undertook this study to compare the efficacy, safety, and tolerability of 3 commonly prescribed calcium channel blockers: amlodipine besylate (Norvasc), nifedipine coat core (CC) (Adalat CC), and nifedipine gastrointestinal therapeutic system (GITS) (Procardia XL).
One hundred ninety-two hypertensive patients across 10 study centers were randomly assigned to double-blind monotherapy with amlodipine besylate (5 mg/d), nifedipine CC (30 mg/d), or nifedipine GITS (30 mg/d) for 8 weeks. Patients not achieving therapeutic response after 4 weeks had their dose doubled for the next 4 weeks. The primary end point was a comparison of the average reduction (week 8 minus baseline) in 24-hour ambulatory diastolic blood pressure (DBP). Secondary end points included a comparison of average 24-hour ambulatory systolic blood pressure (SBP), office SBP or DBP reduction, responder rates, safety, and tolerability.
One hundred sixty-three patients were evaluable for efficacy after 8 weeks. There was no significant difference in the average 24-hour ambulatory DBP (-8.5, -9.0, and -6.1 mm Hg, respectively) or SBP (-14.3, -15.7, and -11.8 mm Hg, respectively) reduction. Average office SBP and DBP were reduced to a comparable degree (19-22 mm Hg [P =.50] and 12-14 mm Hg [P =.51], respectively). Responder rates (DBP <90 or reduced by > or = 10 mm Hg) were similar (P = .38). Discontinuation rates and adverse event frequency were distributed similarly across the 3 treatment groups.
The efficacy, safety, and tolerability of the 3 dihydropyridine calcium channel blockers are equivalent in African Americans with stages 1 and 2 hypertension.
高血压在非裔美国人中是一种常见疾病，且成功治疗率较低。由于钙通道阻滞剂在非裔美国人中耐受性良好且疗效显著，我们开展了这项研究，以比较三种常用钙通道阻滞剂的疗效、安全性和耐受性：苯磺酸氨氯地平（络活喜）、硝苯地平控释片（拜新同）和硝苯地平胃肠道治疗系统制剂（心痛定控释片）。
来自10个研究中心的192例高血压患者被随机分配，接受苯磺酸氨氯地平（5毫克/天）、硝苯地平控释片（30毫克/天）或硝苯地平胃肠道治疗系统制剂（30毫克/天）的双盲单药治疗，为期8周。4周后未达到治疗反应的患者，在接下来的4周内将剂量加倍。主要终点是比较24小时动态舒张压（DBP）的平均降低值（第8周减去基线值）。次要终点包括比较24小时动态收缩压（SBP）的平均值、诊室SBP或DBP的降低值、有效率、安全性和耐受性。
8周后有163例患者可进行疗效评估。24小时动态DBP的平均降低值（分别为-8.5、-9.0和-6.1毫米汞柱）或SBP的平均降低值（分别为-14.3、-15.7和-11.8毫米汞柱）无显著差异。诊室SBP和DBP的平均值降低程度相当（分别为19 - 22毫米汞柱[P = 0.50]和12 - 14毫米汞柱[P = 0.51]）。有效率（DBP <90或降低≥10毫米汞柱）相似（P = 0.38）。停药率和不良事件发生率在3个治疗组中的分布相似。
三种二氢吡啶类钙通道阻滞剂在1级和2级高血压非裔美国人中的疗效、安全性和耐受性相当。
