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| |  Bosentan Reduces Clinical Decline of Patients With Early-Stage Pulmonary Arterial Hypertension NEW YORK -- June 20, 2008 -- Patients with early-stage pulmonary arterial hypertension (PAH) treated with bosentan showed reduced clinical decline compared with patients given placebo, according to a study in this week's edition of The Lancet. Studies have shown that bosentan improves exercise capacity and pulmonary vascular resistance (PVR) and slows clinical decline. However, these studies have focused mainly on patients with advanced disease (World Health Organisation [WHO] functional class [FC] III and IV). Professor Nazzareno Galiè, Institute of Cardiology, University of Bologna, Bologna, Italy, and colleagues, assessed the effects of bosentan on patients with earlier stage PAH (WHO FC class II) in a multicentre, randomised, double-blind, placebo-controlled trial. Patients (N = 185) with WHO FC II PAH, aged 12 years or over, were randomised to receive bosentan (n = 93) or placebo (n = 92) for 6 months. The pulmonary vascular resistance (PVR) of each patient was measured by right heart catheterisation, and also by the distance walked in 6 minutes at the start of the trial. Measurements were taken at baseline and at 6 months. Analyses were done with 168 patients (80 bosentan group, 88 placebo) for PVR and with 177 (86 bosentan, 91 placebo) for 6 minute walking distance. The researchers found that after 6 months, the mean PVR was 83.2% of the baseline value in the bosentan group and 107.5% in the placebo group, giving a statistically significant treatment effect of -22.6% for the patients receiving bosentan. Mean 6 minute walking distance increased 11.2 m in the bosentan group from 438 m at baseline to 449 m, while in the placebo group the walking distance decreased from 431 m at baseline to 423 m. However, the changes in walking distance were not statistically significant. Fewer bosentan-treated patients (3%) experienced clinical worsening events (death, hospitalisation, and symptomatic progression of PAH) compared with the placebo group (14%). This finding was statistically significant. A total of 12 (13%) patients in the bosentan group and 8 (9%) in the placebo group reported serious adverse events. The most common adverse event in the bosentan group was syncope while the most common in the placebo group was right ventricular failure. "The EARLY [Endothelin Antagonist Trial in Mildly Symptomatic PAH Patients] study shows that, if left untreated, mildly symptomatic pulmonary arterial hypertension can progressively deteriorate both clinically and in terms of pulmonary vascular resistance, despite the maintenance of exercise capacity," the authors wrote. "Bosentan treatment in this patient population is associated with improvements in pulmonary vascular resistance and prevention of clinical deterioration. These findings indicate that treatment with bosentan might be of benefit to patients with WHO FC II pulmonary arterial hypertension." SOURCE: The Lancet
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