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首页> 外文期刊>BMC Pulmonary Medicine >Efficacy of 1, 5, and 20?mg oral sildenafil in the treatment of adults with pulmonary arterial hypertension: a randomized, double-blind study with open-label extension
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Efficacy of 1, 5, and 20?mg oral sildenafil in the treatment of adults with pulmonary arterial hypertension: a randomized, double-blind study with open-label extension

机译：1,5和20μlMG口服Sildenafil治疗肺动脉高血压的疗效：随机，双盲研究，具有开放标签延伸

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Background In a previous study, 6-minute walk distance (6MWD) improvement with sildenafil was not dose dependent at the 3 doses tested (20, 40, and 80?mg 3 times daily [TID]). This study assessed whether lower doses were less effective than the approved 20-mg TID dosage. Methods Treatment-naive patients with pulmonary arterial hypertension were randomized to 12?weeks of double-blind sildenafil 1, 5, or 20?mg TID; 12?weeks of open-label sildenafil 20?mg TID followed. Changes from baseline in 6-minute walk distance (6MWD) for sildenafil 1 or 5?mg versus 20?mg TID were compared using a Williams test. Hemodynamics, functional class, and biomarkers were assessed. Results The study was prematurely terminated for non-safety reasons, with 129 of 219 planned patients treated. At week 12, 6MWD change from baseline was significantly greater for sildenafil 20 versus 1?mg ( P =?0.011) but not versus 5?mg. At week 24, 6MWD increases from baseline were larger in those initially randomized to 20 versus 5 or 1?mg (74 vs 50 and 47?m, respectively). At week 12, changes in hemodynamic parameters were generally small and variable between treatment groups; odds ratios for improvement in functional class were not statistically significantly different. Improvements in B-type natriuretic peptide levels were significantly greater with sildenafil 20 versus 1 but not 5?mg. Conclusions Sildenafil 20?mg TID appeared to be more effective than 1?mg TID for improving 6MWD; sildenafil 5?mg TID appeared to have similar clinical and hemodynamic effects as 20?mg TID. Trial registration ClinicalTrials.gov NCT00430716 (Registration date: January 31, 2007).
机译：背景技术在先前的研究中，6分钟的步行距离（6MWD）与西地那非的改善不依赖于测试的3剂（20,40和80μl3次每日[TID]）。本研究评估了低剂量是否比经批准的20mg TID剂量效果较低。方法治疗肺动脉高压患者肺动脉高压患者随机化为12？几周的双盲西地那非1,5，或20μmgTID; 12？几周的开放标签Sildenafil 20？MG TID紧随其后。使用威廉姆斯测试比较Sildenafil 1或5毫克的3分钟步行距离（6MWD）的基线的变化与20？Mg TID进行比较。评估血液动力学，功能阶级和生物标志物。结果本研究终止了非安全原因，129例治疗了129例，共有219例患者。第12周，西地那非20对基线的6MWD变化显着大于1？MG（P = 0.011）但不与5？MG。在第24周，最初从基线增加到6MWD，最初随机为20与5或1？mg（分别为74 Vs 50和47μm）。在第12周，治疗组之间的血流动力学参数的变化通常很小，可变;功能阶级改善的差异比没有统计学显着不同。 Sildenafil 20对1但不是5μg的B型Natrietic肽水平的改善明显大。结论Sildenafil 20？Mg TID似乎比1？Mg Tid改善6MWD更有效;西地那非5？Mg TID似乎具有与20？Mg TID相似的临床和血液动力学效应。试验登记ClinicalTrials.gov NCT00430716（注册日期：2007年1月31日）。

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