Dias V C, Tendler B, Oparil S, Reilly P A, Snarr P, White W B
Department of Clinical Research, Boehringer Ingelheim, Ridgefield, Connecticut, USA.
Am J Ther. 1999 Jan;6(1):19-24. doi: 10.1097/00045391-199901000-00004.
The objective of this study was to assess the efficacy and tolerability of transdermal clonidine in inner-city African-American and Hispanic-American patients with essential hypertension. A multiclinic open-label, prospective trial for 12 weeks was used. Dose titration was based on office blood pressure (BP) measurements of > 140/90 mm Hg. Clinical sites were community-based primary care centers. Untreated and treated hypertensive patients whose diastolic BP exceeded 90 mm Hg were administered transdermal clonidine at 0.1 mg or 0.2 mg delivery daily. The drug was titrated after 1 month if diastolic BP was greater than 90 mm Hg. At 12 weeks of treatment, change in blood pressure from baseline as well as adverse effects and patient satisfaction were assessed. A total of 357 patients entered the treatment phase of the study, and 315 patients (244 African-Americans, 67 Hispanic-Americans) had evaluable data. Transdermal clonidine significantly (P <.001) lowered BP in all patients by 15.7/12.8 +/- 18.1/9.6 mm Hg, and heart rate was reduced by 3 +/- 9 beats/min (P <.001). There were no differences in BP reduction according to race and ethnicity, gender, or age. The most common adverse effects were pruritus or discomfort at the patch site, dizziness, dry mouth, and fatigue. Eleven percent of the patients discontinued treatment because of one of these adverse effects. A large proportion of patients (67%) reported that transdermal clonidine was more convenient to use than oral therapy. Transdermal clonidine, alone or in combination with other antihypertensive therapies, significantly lowered BP and heart rate in inner-city hypertensive patients. The drug was generally well tolerated, with 89% of the patients remaining in the trial. Patient acceptability was high with the once-weekly treatment, which is an important feature for this particular hypertensive population.
本研究的目的是评估透皮可乐定对市中心非裔美国人和西班牙裔美国人原发性高血压患者的疗效及耐受性。采用了一项为期12周的多诊所开放标签前瞻性试验。剂量滴定基于诊室血压（BP）测量值>140/90 mmHg。临床地点为社区初级保健中心。舒张压超过90 mmHg的未治疗和已治疗高血压患者，每天给予0.1 mg或0.2 mg释放量的透皮可乐定。如果舒张压大于90 mmHg，1个月后调整药物剂量。治疗12周时，评估血压相对于基线的变化、不良反应及患者满意度。共有357例患者进入研究的治疗阶段，315例患者（244例非裔美国人，67例西班牙裔美国人）有可评估数据。透皮可乐定使所有患者的血压显著降低（P<.001），收缩压降低15.7/12.8±18.1/9.6 mmHg，心率降低3±9次/分钟（P<.001）。根据种族、民族、性别或年龄，血压降低情况无差异。最常见的不良反应为贴片部位瘙痒或不适、头晕、口干和疲劳。11%的患者因这些不良反应之一而停止治疗。很大一部分患者（67%）报告透皮可乐定比口服治疗更方便使用。透皮可乐定单独或与其他抗高血压疗法联合使用，可显著降低市中心高血压患者的血压和心率。该药物耐受性总体良好，89%的患者完成了试验。每周一次的治疗患者接受度高，这对该特定高血压人群来说是一个重要特征。
