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Bosentan.

Amitabh Prakash1, Caroline M Perry

  • 1Adis International Inc., Langhorne, Pennsylvania 19047, USA. demail@adis.com

American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions
|January 20, 2004
PubMed
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Bosentan, a dual endothelin receptor antagonist, improved exercise capacity and reduced clinical worsening in patients with pulmonary arterial hypertension. These benefits were maintained for at least 20 weeks.

Area of Science:

  • Pharmacology
  • Cardiovascular Medicine
  • Pulmonology

Background:

  • Pulmonary arterial hypertension (PAH) involves endothelin-1-induced vasoconstriction.
  • Existing treatments for PAH include vasodilators, diuretics, and oxygen therapy.

Purpose of the Study:

  • To evaluate the efficacy and safety of bosentan in patients with WHO functional class III or IV PAH.
  • To assess bosentan's impact on exercise capacity and clinical worsening.

Main Methods:

  • Two Phase III clinical trials were conducted.
  • Patients with PAH received either bosentan or placebo, in addition to standard treatments.
  • Efficacy endpoints included exercise capacity, Borg dyspnea index, WHO functional class, and hemodynamic parameters.

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Main Results:

  • Bosentan significantly improved exercise capacity compared to placebo, with benefits sustained for at least 20 weeks.
  • Secondary endpoints, including dyspnea index, functional class, and hemodynamic parameters, showed significant improvement with bosentan.
  • Bosentan significantly reduced the incidence and delayed the onset of clinical worsening of PAH.

Conclusions:

  • Bosentan is an effective oral treatment for patients with WHO functional class III or IV pulmonary arterial hypertension.
  • Bosentan improves exercise capacity, functional status, and hemodynamic parameters in PAH patients.
  • Bosentan reduces clinical worsening events in PAH patients, though adverse events like abnormal hepatic function require monitoring.