BACKGROUND:Peripheral arterial disease (PAD) frequently occurs in patients on hemodialysis (HD); however, little is known about the effectiveness of drugs. We compare the effects of sarpogrelate and cilostazol in HD patients with PAD. METHODS: We conducted a prospective, randomized, open-label, and multicenter trial for 24 weeks in HD patients with PAD. Thirty-five patients were divided into two groups: sarpogrelate (n = 17) and cilostazol (n = 18). We analyzed changes in skin perfusion pressure (SPP), levels of oxidative stress biomarkers, and adverse events. RESULTS: At 24 weeks, SPP was increased in both groups (sarpogrelate, 43 ± 17 to 55 ± 15 mmHg; cilostazol, 49 ± 21 to 66 ± 29 mmHg; p < 0.05), and no difference was observed between the groups. Plasma pentosidine levels decreased in both groups (sarpogrelate, 0.65 ± 0.24 to 0.48 ± 0.12 mg/mL; cilostazol, 0.58 ± 0.22 to 0.47 ± 0.17 mg/mL; p < 0.05), and there were no differences between the groups. Serum malondialdehyde-modified low-density lipoprotein (MDA-LDL) levels significantly increased only in cilostazol group (p < 0.05). There were no clinically significant safety concerns linked to the both drugs. Although blood pressure did not differ in both groups, heart rate increased only in cilostazol group from 77 ± 13 to 83 ± 16 beats per minute (p < 0.05). CONCLUSION:Sarpogrelate improves SPP in HD patients with PAD without increasing heart rate and serum MDA-LDL levels. We demonstrated that sarpogrelate is an effective and safe drug for the treatment of HD patients with PAD.
RCT Entities:
BACKGROUND:Peripheral arterial disease (PAD) frequently occurs in patients on hemodialysis (HD); however, little is known about the effectiveness of drugs. We compare the effects of sarpogrelate and cilostazol in HDpatients with PAD. METHODS: We conducted a prospective, randomized, open-label, and multicenter trial for 24 weeks in HDpatients with PAD. Thirty-five patients were divided into two groups: sarpogrelate (n = 17) and cilostazol (n = 18). We analyzed changes in skin perfusion pressure (SPP), levels of oxidative stress biomarkers, and adverse events. RESULTS: At 24 weeks, SPP was increased in both groups (sarpogrelate, 43 ± 17 to 55 ± 15 mmHg; cilostazol, 49 ± 21 to 66 ± 29 mmHg; p < 0.05), and no difference was observed between the groups. Plasma pentosidine levels decreased in both groups (sarpogrelate, 0.65 ± 0.24 to 0.48 ± 0.12 mg/mL; cilostazol, 0.58 ± 0.22 to 0.47 ± 0.17 mg/mL; p < 0.05), and there were no differences between the groups. Serum malondialdehyde-modified low-density lipoprotein (MDA-LDL) levels significantly increased only in cilostazol group (p < 0.05). There were no clinically significant safety concerns linked to the both drugs. Although blood pressure did not differ in both groups, heart rate increased only in cilostazol group from 77 ± 13 to 83 ± 16 beats per minute (p < 0.05). CONCLUSION:Sarpogrelate improves SPP in HDpatients with PAD without increasing heart rate and serum MDA-LDL levels. We demonstrated that sarpogrelate is an effective and safe drug for the treatment of HDpatients with PAD.
Authors: Patrizia Natale; Suetonia C Palmer; Valeria M Saglimbene; Marinella Ruospo; Mona Razavian; Jonathan C Craig; Meg J Jardine; Angela C Webster; Giovanni Fm Strippoli Journal: Cochrane Database Syst Rev Date: 2022-02-28