Platelet-aggregation inhibition and hemodynamic effects of beraprost sodium, a new oral prostacyclin derivative: a study in healthy male subjects

Canadian Journal of Physiology and Pharmacology
P NonyJ P Boissel

Abstract

The antiaggregation and hemodynamic effects of the new prostacyclin analogue beraprost sodium were investigated in a randomized, placebo-controlled, double-blind clinical trial of Latin-square design. Twelve healthy Caucasian males randomly received 8-day oral treatments of 20, 40, and 60 micrograms of beraprost sodium and a placebo. One-week washout periods followed each treatment. Pharmacokinetic and pharmacodynamic measurements were performed on days 1 and 8 for each period of treatment. All three doses of beraprost sodium significantly inhibited platelet aggregation on day 8 (compared with placebo) during the 1st h after drug intake. Incubation of the 60-micrograms beraprost sodium samples with ADP (2, 5, and 10 microM) and collagen (1.25 micrograms/mL) decreased platelet aggregation by 10, 19, 16, and 6 +/- 4% (mean +/- SE), respectively, compared with placebo. No significant hemodynamic effects on blood pressure, heart rate, and digital pulse were observed. The 60-micrograms dose of beraprost sodium did significantly decrease the IRZ index (which may reflect the left ventricular pre-ejection period) on days 1 and 8. Some subjects experienced headache and facial flushing, effects that were dose dependent and reversible. Be...Continue Reading

Citations

Dec 9, 2004·AACN Clinical Issues·Kenneth J Rempher, Jean Little
May 29, 2009·Clinical and Experimental Pharmacology & Physiology·Kazumasa SeijiShoki Takahashi
Sep 19, 2006·Biochemical and Biophysical Research Communications·Yoshinori MiyaharaNoritoshi Nagaya
Apr 27, 2001·Expert Opinion on Investigational Drugs·J Geiger
Apr 14, 2015·BioMed Research International·Fernando H G TessaroJoilson O Martins

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