Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy.
BACKGROUND
Diabetic nephropathy is the leading cause of end-stage renal disease (ESRD). Cardiovascular (CV) complications are the most common cause of death among ESRD patients. Beraprost sodium (BPS) is a prostacyclin analog with vasodilatory and antiplatelet effects.


METHODS
This is a multicenter prospective, randomized, double-blind, placebo-controlled trial to determine whether treatment with BPS improves arterial stiffness in patients with type 2 diabetic nephropathy. A total of 102 participants with type 2 diabetic nephropathy will be screened, enrolled, and randomly assigned to receive either 80 μg BPS or placebo daily for 12 weeks. The primary outcome is the change in brachial-ankle pulse wave velocity between baseline and after 12 weeks of medication use. The secondary outcomes will include changes in the ankle-brachial index, the urine albumin to creatinine ratio, the estimated glomerular filtration rate, lipid profiles, and blood pressure from baseline to after treatment.


CONCLUSIONS
This clinical trial is the first to investigate the effects of BPS on changes in CV biomarkers, albuminuria, renal function, and lipid profiles in patients with diabetic nephropathy.


BACKGROUND
ClinicalTrials.gov number NCT01796418.
Department Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul 110-799, South Korea. cslimjy@snu.ac.kr.
Ki Young
KY
Na
Dong Ki
DK
Kim
Sung Gyun
SG
Kim
Young-Ki
YK
Lee
Chun Soo
CS
Lim
D055109:Ankle Brachial Index; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D003928:Diabetic Nephropathies / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D004311:Double-Blind Method; D011464:Epoprostenol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D011446:Prospective Studies; D063177:Pulse Wave Analysis; D056910:Republic of Korea; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D059289:Vascular Stiffness / Q000187:drug effects*; D014665:Vasodilator Agents / Q000627:therapeutic use*
D014665:Vasodilator Agents; C048081:beraprost; D011464:Epoprostenol