Randomized pilot trial between prostaglandin I2 analog and anti-platelet drugs on
peripheral arterial disease in hemodialysis patients.
Author(s): Ohtake T(1), Sato M, Nakazawa R, Kondoh M, Miyaji T, Moriya H, Hidaka S,
Kobayashi S.
Affiliation(s): Author information:
(1)Department of Nephrology, Immunology, and Vascular Medicine, Shonan Kamakura
General Hospital, Kamakura, Japan.
Publication date & source: 2014, Ther Apher Dial. , 18(1):1-8
The effect of the prostaglandin I2 analog, beraprost sodium (BPS), on
hemodialysis (HD) patients with peripheral arterial disease (PAD) has not been
fully elucidated. The effect of BPS was compared to that of PAD drugs in HD
patients with PAD in a multicenter randomized prospective interventional pilot
study (J-PADD). Seventy-two PAD patients on HD were entered and randomly divided
into two groups; that is, BPS group (Group A: n = 35) and PAD drug (cilostazol or
sarpogrelate) group (Group B: n = 37). Primary endpoint was changes in skin
perfusion pressure (SPP). Kidney Disease Quality of Life (KDQOL) score,
cardiovascular events, PAD events, and adverse events were also evaluated. SPP
increased significantly in both groups at 24 weeks from their basal levels. The
absolute increase of SPP in Group A and Group B were 15.4 ± 30.0 mm Hg (P <
0.0001) and 20.2 ± 22.1 mm Hg (P = 0.025) (instep), and 13.8 ± 19.3 mm Hg (P <
0.0001) and 9.2 ± 16.3 mm Hg (P = 0.041) (sole), respectively. Changes of KDQOL
score showed significantly better result in the role of physical score in Group A
compared with Group B. Although heart rate was unchanged in Group A, 9.3/min
increase was seen in Group B patients who received cilostazol. There was no
intergroup difference in cardiovascular events and/or PAD events between the two
groups during the study period. This exploratory pilot study suggested BPS was as
effective as anti-platelet drugs in improving microcirculation in HD patients.
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