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ARIES-3: Ambrisentan Therapy in a Diverse Population of Patients with Pulmonary Hypertension

机译:ARIES-3:肺动脉高压患者的多种人群中的安布森坦疗法

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Introduction: Ambrisentan is an oral, once daily, endothelin receptor antagonist approved for treatment of pulmonary arterial hypertension (PAH). Previous studies of ambrisentan were limited to patients with Group 1 PAH and often excluded patients receiving other pulmonary hypertension (PH) therapies. Aims: ARIES-3 was an open-label study evaluating efficacy and safety of ambrisentan in patients with various PH etiologies and background PH medications. Patients received 5 mg ambrisentan once daily for 24 weeks. The primary endpoint was change from baseline in 6-minute walk distance (6MWD) at week 24. Results: A total of 224 patients with PH due to idiopathic and familial PAH (31%), connective tissue disease (18%), chronic hypoxemia (22%), chronic thromboembolic disease (13%), or other etiologies (16%) were enrolled and 53% of patients received stable background PAH therapies. After 24 weeks of therapy, an increase in 6MWD (+21 m; 95% CI: 12-29) and a decrease in B-type natriuretic peptide (-26%; 95% CI: -34 to -16%) was observed in the overall population compared to baseline; however, increases in 6MWD were not observed in several non-Group 1 PH subpopulations. Peripheral edema, headache, and dyspnea were the most common adverse events. Conclusion: This study reconfirms the results of previous placebo-controlled studies, which demonstrate that ambrisentan is well tolerated and provides benefit in patients with PAH. Definitive conclusions regarding the safety and efficacy of ambrisentan in specific non-Group 1 PH etiologies cannot be determined and larger, controlled studies will be necessary to determine the efficacy and safety of ambrisentan in these populations.
机译:简介:Ambrisentan是一种口服,每日一次的内皮素受体拮抗剂,已被批准用于治疗肺动脉高压(PAH)。以前的安布雷森坦研究仅限于第1组PAH患者,并且经常排除接受其他肺动脉高压(PH)治疗的患者。目的:ARIES-3是一项开放性研究,评估了安非生坦在各种PH病因和背景PH药物患者中的疗效和安全性。患者每天一次接受5 mg安布森坦,持续24周。主要终点是在第24周时从6分钟步行距离(6MWD)的基线变化。结果:共有224例因特发性和家族性PAH(31%),结缔组织病(18%),慢性低氧血症引起的PH患者(22%),慢性血栓栓塞性疾病(13%)或其他病因(16%)入组,53%的患者接受了稳定的背景PAH治疗。治疗24周后,观察到6MWD增加(+21 m; 95%CI:12-29),B型利钠肽减少(-26%; 95%CI:-34至-16%)与基线相比的总体人口;但是,在几个非第1组PH亚群中未观察到6MWD的增加。周围水肿,头痛和呼吸困难是最常见的不良事件。结论:本研究证实了以往安慰剂对照研究的结果,该研究表明安贝生坦具有良好的耐受性,并能为PAH患者带来益处。无法确定有关安布森坦在特定的非第1组PH病因中的安全性和有效性的明确结论,因此有必要进行更大范围的对照研究以确定安布森坦在这些人群中的有效性和安全性。

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