Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study):: a double-blind, randomised controlled trial
Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study):: a double-blind, randomised controlled trial
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DOI：
10.1016/s0140-6736(08)60919-8
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发表时间：
2008-06-21
期刊：
影响因子：
168.9
通讯作者：
Simonneau, G.
中科院分区：
文献类型：
--
作者：
Galie, N.;Rubin, L. J.;Simonneau, G.
背景肺动脉高压的治疗主要在晚期疾病（WHO功能分级[FC] III和IV）患者中进行研究。本研究旨在评估双重内皮素受体拮抗剂波生坦在WHO FC II型肺动脉高压患者中的作用。方法12岁或12岁以上的WHO FC II型肺动脉高压患者，6分钟步行距离小于正常预测值的80%或小于500 m，伴有博格呼吸困难指数为2或更高，安慰剂对照、多中心试验。185例患者通过集中集成语音识别系统随机分配接受波生坦（n=93）或安慰剂（n=92）治疗6个月双盲治疗期。主要终点是第6个月时的肺血管阻力，表示为基线的百分比和6分钟步行距离从基线到第6个月的变化。对所有具有有效基线评估和第6个月评估或插补值的随机化患者进行主要终点分析。该试验在ClinicalTrials.gov注册，编号NCT 00091715。结果分析了168例患者（波生坦组80例，安慰剂组88例）的肺血管阻力，177例患者（86例和91例）的6分钟步行距离。第6个月时，波生坦组肺血管阻力几何平均值为基线值的83.2%（95%CI 73.8-93.7），安慰剂组为基线值的107.5%（97.6-118.4）（治疗效果-22.6%，95%CI-33。5到-10 0; p
Background Treatments for pulmonary arterial hypertension have been mainly studied in patients with advanced disease (WHO functional class [FC] III and IV). This study was designed to assess the effect of the dual endothelin receptor antagonist bosentan in patients with WHO FC II pulmonary arterial hypertension.Methods Patients with WHO FC II pulmonary arterial hypertension aged 12 years or over with 6-min walk distance of less than 80% of the normal predicted value or less than 500 m associated with a Borg dyspnoea index of 2 or greater were enrolled in this double-blind, placebo-controlled, multicentre trial. 185 patients were randomly assigned to receive bosentan (n=93) or placebo (n=92) for the 6-month double-blind treatment period via a centralised integrated voice recognition system. Primary endpoints were pulmonary vascular resistance at month 6 expressed as percentage of baseline and change from baseline to month 6 in 6-min walk distance. Analyses of the primary endpoints were done with all randomised patients who had a valid baseline assessment and an assessment or an imputed value for month 6. This trial was registered with ClinicalTrials.gov, number NCT00091715.Findings Analyses were done with 168 patients (80 in the bosentan group, 88 in the placebo group) for pulmonary vascular resistance and with 177 (86 and 91) for 6-min walking distance. At month 6, geometric mean pulmonary vascular resistance was 83.2% (95% Cl 73.8-93.7) of the baseline value in the bosentan group and 107.5% (97.6-118.4) of the baseline value in the placebo group (treatment effect -22.6%, 95% Cl -33. 5 to -10 . 0; p