BOSENTAN THERAPY FOR PULMONARY ARTERIAL HYPERTENSION

BOSENTAN THERAPY FOR PULMONARY ARTERIAL HYPERTENSION

March 21, 2002 | LEWIS J. RUBIN, M.D., DAVID B. BADESCH, M.D., ROBYN J. BARST, M.D., NAZZARENO GALIE, M.D., CAROL M. BLACK, M.D., ANNE KEOGH, M.D., TOMAS PULIDO, M.D., ADAANI FROST, M.D., SEBASTIEN ROUX, M.D., ISABELLE LECONTE, PH.D., MICHAEL LANDZBERG, M.D., AND GERALD SIMONNEAU, M.D., FOR THE BOSENTAN RANDOMIZED TRIAL OF ENDOTHELIN ANTAGONIST THERAPY STUDY GROUP
The study evaluated the efficacy and safety of bosentan, an endothelin-receptor antagonist, in patients with pulmonary arterial hypertension (PAH). In a double-blind, placebo-controlled trial, 213 patients were randomly assigned to receive either placebo or bosentan at two doses (62.5 mg or 125/250 mg twice daily) for a minimum of 12 weeks. The primary endpoint was the change in six-minute walking distance, with secondary endpoints including the Borg dyspnea index, World Health Organization (WHO) functional class, and time to clinical worsening. After 16 weeks, patients treated with bosentan showed a significant improvement in walking distance (mean difference of 44 m, P=0.001), Borg dyspnea index, WHO functional class, and time to clinical worsening. The 125 mg dose was well tolerated, while the 250 mg dose led to a higher frequency of abnormal liver function tests. The study concluded that bosentan is beneficial and well-tolerated in patients with PAH, particularly at a dose of 125 mg twice daily.The study evaluated the efficacy and safety of bosentan, an endothelin-receptor antagonist, in patients with pulmonary arterial hypertension (PAH). In a double-blind, placebo-controlled trial, 213 patients were randomly assigned to receive either placebo or bosentan at two doses (62.5 mg or 125/250 mg twice daily) for a minimum of 12 weeks. The primary endpoint was the change in six-minute walking distance, with secondary endpoints including the Borg dyspnea index, World Health Organization (WHO) functional class, and time to clinical worsening. After 16 weeks, patients treated with bosentan showed a significant improvement in walking distance (mean difference of 44 m, P=0.001), Borg dyspnea index, WHO functional class, and time to clinical worsening. The 125 mg dose was well tolerated, while the 250 mg dose led to a higher frequency of abnormal liver function tests. The study concluded that bosentan is beneficial and well-tolerated in patients with PAH, particularly at a dose of 125 mg twice daily.
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