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To: keokalani'nui who wrote (823)10/5/2001 11:55:42 AM
From: keokalani'nui  Read Replies (1) | Respond to of 834
 
Bosentan in The Lancet.

WESTPORT, CT (Reuters Health) - Bosentan, a dual endothelin-receptor antagonist, improves the exercise capacity and hemodynamics of patients with pulmonary hypertension, according to a report published in the October 6th issue of The Lancet.

Bosentan, which is produced by Swiss drug company Actelion Ltd. under the brand name Tracleer, is currently under review by the US Food and Drug Administration.

Dr. Richard N. Channick from the University of California at San Diego and colleagues note that the endogenous vasoconstrictor endothelin 1 is thought to be a cause of pulmonary hypertension. The investigators randomized 32 patients with pulmonary hypertension to receive bosentan or placebo for a minimum of 12 weeks. Bosentan was started at a dose of 62.5 mg twice daily for the first 4 weeks and then increased to 125 mg twice daily.

At the end of 12 weeks, the 6-minute walking distance of bosentan-treated patients had increased by 70 m, while that of placebo-treated patients decreased by 6 m, the authors note (p = 0.021). Also, the difference in cardiac index was significant (p < 0.0001) between bosentan-treated patients and placebo-treated patients, as was the difference in pulmonary vascular resistance (p = 0.0002).

Adverse effects were equally common in both groups in terms of incidence and severity, the researchers note. Three patients in the placebo group stopped therapy due to clinical worsening.

Since the current study involved only patients with primary or scleroderma-associated pulmonary hypertension, further studies are needed to evaluate bosentan's effects on other types of pulmonary hypertension, the authors note.

In a related commentary, Dr. Jocelyn Dupuis, from the University of Montréal, emphasizes that future trials should address whether dual endothelin-receptor blockers actually lead to an "improvement in survival, and the role of these agents in class IV patients with or without concomitant epoprostenol therapy."

Lancet 2001;358:1113-1114,1119-1123.