Tytus Richard H, Burgess Ellen D, Assouline Linda, Vanjaka Anita
Hamilton Health Sciences, Hamilton, Ontario, Canada.
Clin Ther. 2007 Feb;29(2):305-15. doi: 10.1016/j.clinthera.2007.02.016.
This study evaluated the effectiveness of an escalating-dose regimen of trandolapril in subjects with stage 1 or stage 2 hypertension.
This was a 26-week, prospective, open-label,multicenter study in Canadian primary care centers. Subjects with hypertension who were treatment naive or whose disease was uncontrolled on current first-line antihypertensive monotherapy were treated with trandolapril for 26 weeks alone or in addition to their current treatment. Uncontrolled hypertension was defined as systolic/diastolic blood pressure (SBP/DBP) >or=140/90 mm Hg in subjects with no other risk factors or >or=130/80 mm Hg in subjects with diabetes or kidney disease. Trandolapril therapy was initiated at 1 mg/d and was titrated as required to 2 or 4 mg at 4 and 9 weeks after initiation of treatment, respectively, in those not achieving BP targets. At 14 weeks after treatment initiation, subjects not achieving BP targets could receive a combination of trandolapril 4 mg plus a calcium channel blocker (verapamil 240 mg) with or without a diuretic. Primary outcome was the percentage of patients reaching target BP after 14 weeks.
A total of 1683 subjects from 192 general practice clinics across Canada completed the 14-week trandolapril dose-optimization phase, and 1650 completed the full 26-week follow-up. Mean (SD) age was 56.6 (12.6) years, and 49.2% of the subjects were men. At baseline, 82.4% (1359/1650) of subjects were antihypertensive-treatment naive. At the trial end, 73.4% (95% CI, 70.9-75.9) of subjects achieved a target level of SBP/DBP <140/90 mm Hg. The mean (SD) reductions in SBP and DBP were -21.5 (14.0) and -11.9 (9.1) mm Hg, respectively (P < 0.001), and -22.4 (14.0) and -12.7 (9.0) mm Hg, respectively (P < 0.001), at 26 weeks. A total of 343 predominantly mild, nonserious adverse events were attributed to the study drugs, reported by 252 (15.3%) of the 1650 subjects. The most frequently reported nonserious adverse events were cough (6.3%); gastrointestinal disorders (2.3%), predominantly nausea; and headache (2.1%). No serious adverse events were attributed to the study treatment. Trandolapril was generally well tolerated.
A titration-based, escalating-dose regimen of trandolapril was effective and well tolerated in the management of these subjects who were antihypertensive-treatment naive or whose disease was uncontrolled on a diuretic or a calcium channel blocker in this open-label, uncontrolled, multicenter study. Overall, 73.4% of subjects achieved their target blood pressure goal (<140/90 mm Hg).
本研究评估了逐步递增剂量的群多普利方案对1期或2期高血压患者的疗效。
这是一项在加拿大初级保健中心进行的为期26周的前瞻性、开放标签、多中心研究。对未接受过治疗或当前一线抗高血压单药治疗未能控制病情的高血压患者，单独使用群多普利治疗26周，或在其当前治疗基础上加用群多普利治疗。未控制的高血压定义为：无其他危险因素的患者收缩压/舒张压（SBP/DBP）≥140/90 mmHg，或患有糖尿病或肾病的患者SBP/DBP≥130/80 mmHg。群多普利治疗起始剂量为1 mg/d，在治疗开始后4周和9周，若未达到血压目标，则分别按需滴定至2 mg或4 mg。在治疗开始14周后，未达到血压目标的患者可接受群多普利4 mg加钙通道阻滞剂（维拉帕米240 mg）联合或不联合利尿剂的治疗。主要结局是14周后达到目标血压的患者百分比。
来自加拿大192家全科诊所的1683名受试者完成了为期14周的群多普利剂量优化阶段，1650名受试者完成了完整的26周随访。平均（标准差）年龄为56.6（12.6）岁，49.2%的受试者为男性。基线时，82.4%（1359/1650）的受试者未接受过抗高血压治疗。试验结束时，73.4%（95%CI，70.9 - 75.9）的受试者达到了SBP/DBP <140/90 mmHg的目标水平。在26周时，SBP和DBP的平均（标准差）降低值分别为-21.5（14.0）和-11.9（9.1）mmHg（P < 0.001），以及-22.4（14.0）和-12.7（9.0）mmHg（P < 0.001）。1650名受试者中有252名（15.3%）报告了总共343起主要为轻度、非严重的不良事件，这些事件归因于研究药物。最常报告的非严重不良事件是咳嗽（6.3%）；胃肠道疾病（2.3%），主要是恶心；以及头痛（2.1%）。没有严重不良事件归因于研究治疗。群多普利总体耐受性良好。
在这项开放标签、非对照、多中心研究中，基于滴定的逐步递增剂量群多普利方案在治疗未接受过抗高血压治疗或使用利尿剂或钙通道阻滞剂未能控制病情的患者时有效且耐受性良好。总体而言，73.4%的受试者达到了目标血压目标（<140/90 mmHg）。
