Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy

Ki Young Na, Dong Ki Kim, Sung Gyun Kim, Young-Ki Lee, Chun Soo Lim, Ki Young Na, Dong Ki Kim, Sung Gyun Kim, Young-Ki Lee, Chun Soo Lim

Abstract

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.

Discussion: 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.

Trial registration: ClinicalTrials.gov number NCT01796418.

Figures

Figure 1
Figure 1
Study algorithm. BPS, beraprost sodium.
Figure 2
Figure 2
Study schedule. ABI, ankle-brachial index; ba-PWV, brachial-ankle pulse wave velocity; BP, blood pressure; BPS, beraprost sodium; Cr, creatinine; d, days; LDL, low-density lipoprotein; PR, pulse rate; R, randomization; T-chol, total cholesterol; TG, triglycerides; UACR, urine albumin to creatinine ratio; w, weeks.

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Source: PubMed

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