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Actelion Announces Positive Study with Bosentan (Tracleer) in,CTEPH

ients may still have persistent or recurrent pulmonary hypertension 2. New treatment options are therefore required for both patient groups. Latest estimates put the number of new CTEPH patients at up to 5000 annually. In the 157 patient study BENEFiT, treatment with bosentan was associated with a highly significant reduction in pulmonary vascular resistance (PVR) compared to placebo (p<0.0001) and increase in cardiac index (p=0.0007). Borg dyspnoea index was also significantly improved (p=0.0386) and there was a trend in favor of bosentan towards prevention of worsening functional WHO class (p=0.1682, ns). Treatment with bosentan was also associated with a significant decrease in NT-proBNP (p = 0.0028), an important biomarker of disease severity. Other clinical parameters, such as time to clinical worsening and quality of life were consistently trending in favor of bosentan. Tracleer®'s safety and tolerability profile was consistent with that observed in previous placebo-controlled clinical trials in pulmonary arterial hypertension (PAH) 3. Upon complete data analysis, Actelion will present study results at upcoming scientific conferences, such as at the American Thoracic Society (ATS) meeting in San Francisco in May. BENEFiT study design in detail The BENEFiT (Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension) study is the first double blind, randomized, placebo-controlled, parallel-group study in CTEPH patients. BENEFiT enrolled 157 patients in 26 centers in 13 countries. The mean age of patients enrolled in the study was 63 years and 65% of patients were female. Patients had either inoperable CTEPH or persistent or recurrent Pulmonary Hypertension after PEA (at least 6 months after hospital discharge).

The regimen for bosentan was 62.5mg bid for the first 4 weeks of treatment, increasing to 125mg bid for the following 12 weeks of the study. The primary objective of the study was to prove the efficacy of bosentan, wh
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TAG: Actelion Announces Positive Study with Bosentan Tracleer CTEPH
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