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PJ Online homeThe Pharmaceutical Journal
Vol 278 No 7454 p639
2 June 2007

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Pharmacological option for inoperable chronic thromboembolic pulmonary hypertension

Patients with inoperable chronic thromboembolic pulmonary hypertension can be successfully treated with the endothelin receptor antagonist bosentan (Tracleer), data from a phase III trial presented at last week's American Thoracic Society meeting in San Francisco suggest.

Chronic thromboembolic pulmonary hypertension occurs when pulmonary arteries become obstructed by thrombi, leading to increased vascular resistance. The condition develops in up to 3.8 per cent of patients who survive an acute pulmonary embolism. Standard treatment involves complex surgery but patients may be unsuitable due to their age, coexisting conditions or inaccessible thrombi.

The double-blind trial, known as BENEFIT, looked at 157 of these patients and randomised them to receive bosentan or placebo for 16 weeks.

Treatment with bosentan was associated with a 24.1 per cent drop in the primary outcome of pulmonary vascular resistance (P<0.0001) and Borg dyspnoea score improved by –0.6 (P=0.0386). However, functioning, as measured by the six-minute walk test, remained unchanged in both groups.

Lewis Rubin, of the University of California, San Diego, and a member of the BENEFIT steering group, commented: “We’re not quite sure why the [six-minute walk test] didn’t improve but it might be because these patients were fairly old [average age 63 years] and it might take longer than this follow up to see improvements. But the fact that PVR dropped with bosentan is significant.”

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