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Bosentan Plus Sildenafil Improves Hemodynamics in PAH
By Martha Kerr
CHICAGO (Reuters Health) Oct 26 - Data from a large registry presented here this week at CHEST 2007, the 73rd annual international scientific assembly of the American College of Chest Physicians, show that combination therapy for pulmonary arterial hypertension (PAH) with sildenafil and bosentan improves hemodynamics and may delay progression of disease.
The Endothelin Antagonist Trial in Mildly Symptomatic PAH Patients (EARLY) involved 29 patients with PAH on sildenafil at baseline out of a total of 185 patients in the EARLY registry. Patients were randomized to bosentan, 62.5 mg twice daily for four weeks then 125 mg twice a day, or placebo in addition to sildenafil.
Dr. Nazzareno Galie of the University of California at San Diego presented the data after six months of follow-up.
At baseline, patients had a six-minute walk-test that was less than 80% of expected. Mean baseline pulmonary vascular resistance (PVR) was approximately 1,000 dynes/sec/cm-5. With combination therapy, that fell to approximately 650 dynes/sec/cm-5, Dr. Galie reported.
After six months, there was a 20% reduction in PVR in patients on combination therapy compared with those on sildenafil alone. Median improvement in six-minute walk-test was 5 meters, which did not reach statistical significance.
Dr. Galie said there appeared to be \"a delay in clinical worsening\" with the addition of bosentan.
\"Combination therapy is a new concept,\" Dr. Galie told Reuters Health. \"The addition of bosentan was safe and it induces an acute hemodynamic improvement.\"
Whether sildenafil or bosentan is started first doesn't matter when combination therapy is required, Dr. Galie said. \"The effect is bidirectional,\" he said.
For patients whose disease is still not well-controlled, studies are underway investigating the addition of a third agent, the intravenous prostanoid epoprostenol. |
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发表于 2007-11-8 07:50:23