Effectiveness of beraprost sodium in maintaining vascular access patency in patients on hemodialysis.

PURPOSE: Hemodialysis vascular access dysfunction, mostly attributed to neointimal hyperplasia, is a major cause of morbidity and hospitalization in patients on hemodialysis. It has been reported that prostaglandin I2 has pleiotropic effects including anti-platelet, vasodilating, anti-inflammatory, and anti-atherogenic properties. In addition, several studies have shown that prostaglandin I2 can inhibit neointimal formation after vascular injury. This study aimed to investigate the effects of beraprost sodium, an oral synthetic analog of prostaglandin I2 , on vascular access patency in patients on hemodialysis who experienced primary hemodialysis vascular access failure.

METHODS: Fifty-five patients with end-stage renal disease who were on hemodialysis were prospectively selected for this study. Twenty-three patients were assigned to be treated with 120 µg/day of beraprost sodium, while remaining patients (n = 32) were assigned to a control group. The primary outcome was primary unassisted vascular access patency at 2 years.

RESULTS: The incidence of primary unassisted patency at 2 years was 83% in the beraprost sodium group and 38% in the control group (p = 0.001). Analysis of covariables indicated that this effect occurred mainly as a result of beraprost sodium administration. No life-threatening adverse event or severe bleeding was recorded in any of the groups.

CONCLUSIONS: Our data indicated that an oral prostaglandin I2 analog, beraprost sodium, is effective and safe for the maintenance of vascular access patency in patients on hemodialysis with primary vascular access failure.