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Randomized Pilot Trial Between Prostaglandin I 2 Analog and Anti‐Platelet Drugs on Peripheral Arterial Disease in Hemodialysis Patients
Author(s) -
Ohtake Takayasu,
Sato Motoyoshi,
Nakazawa Ryoichi,
Kondoh Morihiro,
Miyaji Takehiko,
Moriya Hidekazu,
Hidaka Sumi,
Kobayashi Shuzo
Publication year - 2014
Publication title -
therapeutic apheresis and dialysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.415
H-Index - 53
eISSN - 1744-9987
pISSN - 1744-9979
DOI - 10.1111/1744-9987.12051
Subject(s) - medicine , hemodialysis , randomized controlled trial , adverse effect , cilostazol , aspirin
The effect of the prostaglandin I 2 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 ( G roup B : n = 37). Primary endpoint was changes in skin perfusion pressure ( SPP ). K idney D isease Q uality of L ife ( 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 G roup A and G roup 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 G roup A compared with G roup B . Although heart rate was unchanged in G roup A , 9.3/min increase was seen in G roup 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.