Chest
Original ResearchPulmonary Arterial HypertensionSitaxsentan for the Treatment of Pulmonary Arterial Hypertension: A 1-Year, Prospective, Open-Label Observation of Outcome and Survival
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Patients
Two hundred twenty-nine patients aged 12 to 78 years in WHO functional class II-IV with idiopathic PAH (IPAH) or PAH associated with connective tissue disease (PAH-CTD) or PAH associated with a congenital heart defect (PAH-CHD) were enrolled in STRIDE-2X. Additional inclusion criteria have been published previously.7 The study was conducted according to ethical principles stated in the Declaration of Helsinki (1996) and applicable guidelines on good clinical practice. The protocol was approved
Demographics
The sitaxsentan and bosentan treatment groups in the analysis population were comparable with regards to baseline characteristics (Table 1). Patients ranged in age from 14 to 78 years (mean, 54 years), and approximately 77% were female. Approximately 60% of patients had IPAH, 30% had PAH-CTD, and 10% had PAH-CHD. Baseline characteristics of patients in predefined subgroups were similar.
The overall treatment population of 229 patients was randomized to sitaxsentan (n = 145) or standard-dose
Discussion
We report 1-year results with the selective ET-A receptor antagonist sitaxsentan coupled with 1-year outcomes with the nonselective ET-A/ET-B receptor antagonist bosentan in a broad class of PAH patients (inclusion of IPAH [approximately 60%] and associated PAH conditions, ie, PAH-CTD [approximately 30%] and PAH-CHD [approximately 10%] with baseline functional class II-IV). It is important to recognize that although the STRIDE-2X study looked at patients who initiated treatment with sitaxsentan
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The authors have no conflicts of interest to disclose.
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