SESSION TITLE: Pulmonary Hypertension
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 28, 2013 at 01:45 PM - 03:15 PM
PURPOSE: Vasoconstrictive endothelin signaling has been implicated in pulmonary hypertension due to valvular heart disease. The efficacy and safety of endothelin receptor antagonists in this subpopulation is unknown. In this prospective pilot study we investigated the effects of bosentan in patients with pulmonary hypertension due to rheumatic fever-associated mitral stenosis
METHODS: This was a prospective, single center, open-label, uncontrolled study of regular-dosed oral bosentan in outpatients with pulmonary hypertension (PH) due to rheumatic fever-associated uncorrected mitral stenosis. Primary end-point was exercise capacity at six months as demonstrated by the six-minute walking test (6MWD) and maximal oxygen uptake (VO2max). Secondary end-points were BORG Dyspnea Index (BDI), echocardiographic left ventricular ejection fraction (LVEF), pulmonary arterial pressure (PAP), serum pro-brain natriuretic peptide (pro-BNP) and adverse events.
RESULTS: Ten patients (80% females) with a mean age of 75 were enrolled. Bosentan was well tolerated by nine; one withdrew within a month due to subjective clinical deterioration. By intention-to-treat analysis, bosentan resulted in marked increase in 6MWD test (p=0.015) but a significant reduction in VO2max (-0.45 ml/min/kg; p=0.011). Peak PAP did not change considerably but mean PAP dropped by -16% (p=0.03) and LVEF increased by 6.5% (p=0.003). Importantly, profound reductions were observed in BDI and serum pro-BNP (-67% and -37%; P=0.002 and P=0.011, respectively). Adverse events included minor reductions in body mass and hemoglobin.
CONCLUSIONS: Endothelin receptor antagonism with bosentan appears to improve the functional status of patients with pulmonary hypertension due to valvular heart disease. The beneficial effect was reflected by the improvement in 6MWD test, a superior outcome measurement as determined by the pre-existing literature on PH. The drug was safe and well-tolerated by the patients.
CLINICAL IMPLICATIONS: This study suggests that- pending randomized controlled trials- bosentan and other similar drugs, may prove beneficial in patients with PH due to left heart valvular disease
DISCLOSURE: The following authors have nothing to disclose: Georgios Vlachogeorgos, Irene Kourbeti, Nicholaos Daskalopoulos, Panayiotis Blatsiotis, Ioannis Mantas, Georgios Stathopoulos
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