By Megan Rauscher
WESTPORT, CT (Reuters Health) – One year of treatment with beraprost, an oral prostacyclin analogue, led to long lasting clinical and hemodynamic improvement in 11 of 13 patients with severe pulmonary arterial hypertension. Researchers from Italy and Belgium report the finding in the December issue of the journal Heart.
In an interview with Reuters Health, Dr. Robert Naeije of Erasme University Hospital in Brussels noted that "until recently, pulmonary arterial hypertension was considered incurable and uniformly fatal, with an average survival of only 2.5 years." But that changed in the early 1990s when a series of studies showed that continuous IV administration of prostacyclin improved functional state, exercise capacity, hemodynamics and survival in these patients.
In the latter half of the '90s, a series of studies performed in Japan and Europe hinted that the oral prostacyclin analogue beraprost might be as effective as IV prostacyclin for pulmonary arterial hypertension with fewer drawbacks, he continued. Long-term results from the European counterpart of these studies are now published in Heart.
In the 13 patients studied, oral beraprost was initiated at 20 micrograms three to four times per day. After 1 month, the dose was increased to 40 micrograms three to four times per day, with additional increases if needed.
After 1 month, patients as a group experienced a decrease in New York Heart Association (NYHA) functional class of 3.4 to 2.9 (p<0.05), an improvement in the 6-minute walking test of 63 meters (p<0.05), and a nonsignificant decrease in systolic pulmonary artery pressure, 93 to 85 mm/Hg.
One patient died and one was lost to follow-up. During 12 months of treatment, the remaining 11 saw "substantial and persistent improvements" in NYHA class and exercise capacity and a "significant decrease in systolic pulmonary artery pressure," Dr. Naeije and colleagues report.
"Oral beraprost can be a satisfactory alternative to IV prostacyclin," Dr. Naeije said, adding that a randomized trial may be warranted. "The indications of beraprost have to be precise based on more extensive clinical experience which is already accumulating," he said. The optimal dose of oral beraprost is not yet known.
Dr. Naeije also emphasized that prostacyclins "do not offer a cure, only a palliation, even if it corresponds to an average doubling of good quality survival. Therefore, research on new and hopefully more active agents will continue."