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Medical > Therapy > Specific treatments

Prostanoids
Oral beraprost sodium

Oral beraprost is the first orally active prostacylin analogue with a half life of 30-45 minutes. In the prospective randomized placebo-controlled ALPHABET trial oral beraprost at the median dose of 80 µg four times a day, starting at 20 µg four times a day and aiming at a dose of 120 µg four times a day was compared with placebo in 65 patients each over a period of 12 weeks (Galie et al. 2002). The median distance walked improved in the beraprost group from 362 m to 377 m and decreased in the placebo group from 383 m to 374 m resulting in a mean difference in the distance walked in 6 minutes between beraprost and placebo of 25 m. Subgroup analysis revealed that only patients with IPAH improved their exercise tolerance with a difference of 46 m in the 6-minute walk test between beraprost and placebo. More than half of the patients suffered from PAH associated with congenital cardiac shunts, portal hypertension, collagen vascular diseases and HIV infection, and these patients did not benefit from beraprost. Notably, this study so far is the only one that explicitly included patients with NYHA II (half of the study patients) with a demonstrable beneficial effect also in this milder form of PAH.

In a second long-term study of beraprost 120 µg four times a day (Barst et al. 2003), the increase in the 6-minute walking distance was significant at 6 months only (+25 m), but not at 12 months (+23 m). Moreover, there were no meaningful differences in functional class, quality of life or hemodynamics.

References

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