Pulmonary arterial hypertension-related morbidity is prognostic for survival: insights from the SERAPHIN and GRIPHON studies
EUROPEAN RESPIRATORY JOURNAL(2018)
摘要
Clinical and registry data suggest that pulmonary arterial hypertension (PAH) progression is indicative of poor prognosis. The prognostic relevance of PAH-related morbidity was evaluated based on observations from randomized controlled trials, SERAPHIN (N=742) and GRIPHON (N=1156). Both studies were double-blind, long-term, event-driven Phase III trials. In both, the primary endpoint was a composite of morbidity/mortality, prospectively defined and independently adjudicated. At three landmark time points, Months 3, 6 and 12, the risk of all-cause death until end of study was assessed according to whether patients had experienced a primary endpoint morbidity event up to the landmark. At Month 3, 720 SERAPHIN patients were at risk of death. Of those, 38 had experienced a morbidity event up to Month 3. Within the median follow-up period of 27 months, patients had u003e3-fold increased risk of death compared with the 682 patients who had not experienced a morbidity event up to Month 3 (HR 3.39 [95% CI 1.94, 5.92]). Similar observations were made in the GRIPHON population: 1127 patients were at risk of death at Month 3; 62 patients had experienced a morbidity event up to Month 3 and had u003e4-fold increased risk of death within the next 20 months (median follow-up) compared with the 1065 patients who had not (HR 4.48 [95% CI 2.98, 6.73]). In both studies, analyses at Months 6 and 12 yielded similar findings. These results confirm the prognostic relevance of PAH-related morbidity and the importance of its prevention in patients with PAH.
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