Combination of bosentan with epoprostenol in pulmonary arterial hypertension: BREATHE-2
| Autor: | Rj Barst, Anco Boonstra, Rn Channick, Em Horn, Im Robbins, Nazzareno Galiè, LJ Rubin, Marc Humbert, Alessandra Manes, Gérald Simonneau |
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| Přispěvatelé: | Humbert M, Barst RJ, Robbins IM, Channick RN, Galie N, Boonstra A, Rubin LJ, Horn EM, Manes A, Simonneau G |
| Rok vydání: | 2004 |
| Předmět: |
Pulmonary and Respiratory Medicine
Male Time Factors Ambrisentan Hypertension Pulmonary Placebo law.invention Randomized controlled trial Double-Blind Method law Sitaxentan medicine Humans Prospective Studies Adverse effect Antihypertensive Agents Sulfonamides Exercise Tolerance business.industry Endothelin receptor antagonist Hemodynamics Bosentan Middle Aged Epoprostenol respiratory tract diseases Clinical trial Anesthesia Drug Therapy Combination Female Safety business medicine.drug |
| Zdroj: | The European respiratory journal. 24(3) |
| ISSN: | 0903-1936 |
| Popis: | The efficacy and safety of combining bosentan, an orally active dual endothelin receptor antagonist and epoprostenol, a continuously infused prostaglandin, in the treatment of pulmonary arterial hypertension (PAH) was investigated. In this double-blind, placebo-controlled prospective study, 33 patients with PAH started epoprostenol treatment (2 ng.kg(-1)min(-1) starting dose, up to 14+/-2 ng.kg(-1)min(-1) at week 16) and were randomised for 16 weeks in a 2:1 ratio to bosentan (62.5 mg b.i.d for 4 weeks then 125 mg b.i.d) or placebo. Haemodynamics, exercise capacity and functional class improved in both groups at week 16. In the combination treatment group, there was a trend for a greater (although nonsignificant) improvement in all measured haemodynamic parameters. There were four withdrawals in the bosentan/epoprostenol group (two deaths due to cardiopulmonary failure, one clinical worsening, and one adverse event) and one withdrawal in the placebo/epoprostenol group (adverse event). This study showed a trend but no statistical significance towards haemodynamics or clinical improvement due to the combination of bosentan and epoprostenol therapy in patients with pulmonary arterial hypertension. Several cases of early and late major complications were reported. Additional information is needed to evaluate the risk/benefit ratio of combined bosentan-epoprostenol therapy in pulmonary arterial hypertension. |
| Databáze: | OpenAIRE |
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