|Real-World Bosentan Therapy Successful in Pulmonary Arterial Hypertension: Presented at ATS|
|Wednesday, 19 May 2010 19:22|
Real-life experiences in treating patients with pulmonary arterial hypertension with bosentan appears to provide similar efficacy as seen in clinical trials -- despite patients being somewhat older and having more scleroderma, researchers said today here at the American Thoracic Society (ATS) 2010 International Conference.
"We also found that in our population of patients abnormal liver function tests were observed more often than in clinical trials," said Nathan Dwyer, MD, Pulmonary Medicine, Foothills Medical Center, Calgary, Alberta. He conducted his work at Royal Hobart Hospital, Hobart, Tasmania, Australia.
"Overall, we found that bosentan and other endothelin-receptor antagonists used to treat pulmonary arterial hypertension are effective in treating patients who may fall outside the tight criteria for patients in clinical trials," Dr. Dwyer said during his poster presentation.
He said that of the 152 patients treated in Tasmania, 23 patients developed abnormal liver function tests that required 20 of those patients to discontinue bosentan treatment. "You have to monitor these patients for liver function abnormalities very closely," he said.
Oedema also occurred frequently, occurring in 31 of his patients, but treatment with spironolactone was able to treat the oedema. Only 2 patients had to discontinue therapy due to oedema, he reported.
"The treated population differed from that in clinical trials by being older, having more Scleroderma, more comorbidities, and lower average walk distances," he said.
In the 6-minute walk test, subjects improved in their physical activity by about 60 metres from a baseline of about 300 metres. "We observed that this improvement was retained for at least 5 years," Dr. Dwyer said. The improvement was similar in those patients with idiopathic pulmonary arterial hypertension and in scleroderma pulmonary arterial hypertension.
"Bosentan was well tolerated and resulted in significant benefits over a 5-year period," he said. "These data represent what might be expected in a population including all morbidities."
The patients were followed from 2003 through 2008. The researchers achieved a 100% follow-up of these patients. Their mean age was 63 years, and 121 of the participants were women. All of the patients were in New York Heart Association class 3 or 4.
Funding for this study was provided by Actelion, CSL, and Bayer.
Source: Doctor's Guide