期刊论文详细信息
Trials
Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy
Chun Soo Lim1  Young-Ki Lee2  Sung Gyun Kim4  Dong Ki Kim5  Ki Young Na3 
[1] Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul 156-707, South Korea;Kangnam Sacred Heart Hospital, 948-1 Daerim1 dong, Yeongdeungpo-gu, Seoul 150-950, South Korea;Department Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul 110-799, South Korea;Hallym University Sacred Heart Hospital, 896 Pyeongchon-dong, Dongan-gu, Anyang, Gyeonggi-do 431-070, South Korea;Seoul National University Hospital, 101 Daehak-ro Jongno-gu, Seoul 110-744, South Korea
关键词: Pulse wave velocity;    Cardiovascular;    Diabetic nephropathy;    Arterial stiffness;    Beraprost sodium;   
Others  :  1093149
DOI  :  10.1186/1745-6215-14-275
 received in 2013-06-14, accepted in 2013-08-22,  发布年份 2013
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【 摘 要 】

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

【 授权许可】

   
2013 Na et al.; licensee BioMed Central Ltd.

【 预 览 】
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【 参考文献 】
  • [1]Collins AJ, Foley RN, Chavers B, Gilbertson D, Herzog C, Johansen K, Kasiske B, Kutner N, Liu J, St Peter W, Guo H, Gustafson S, Heubner B, Lamb K, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Thompson B, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Daniels F, Ebben J, et al.: United States renal data system 2011 annual data report: atlas of chronic kidney disease and end-stage renal disease in the United States. Am J Kidney Dis 2012, 59(Suppl 1):e1-e420.
  • [2]Jin DC, Ha IS, Kim NH, Lee SW, Lee JS, Yoon SR, Kim BS: Brief report: renal replacement therapy in Korea, 2010. Kidney Res Clin Pract 2012, 31:62-71.
  • [3]Gaede P, Lund-Andersen H, Parving HH, Pedersen O: Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 2008, 358:580-591.
  • [4]Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O: Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med 2003, 348:383-393.
  • [5]Gaede P, Vedel P, Parving HH, Pedersen O: Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. Lancet 1999, 353:617-622.
  • [6]Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY: Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med 2004, 351:1296-1305.
  • [7]Rubin MF, Rosas SE, Chirinos JA, Townsend RR: Surrogate markers of cardiovascular disease in CKD: what’s under the hood? Am J Kidney Dis 2011, 57:488-497.
  • [8]Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM: Impact of aortic stiffness on survival in end-stage renal disease. Circulation 1999, 99:2434-2439.
  • [9]Shoji T, Emoto M, Shinohara K, Kakiya R, Tsujimoto Y, Kishimoto H, Ishimura E, Tabata T, Nishizawa Y: Diabetes mellitus, aortic stiffness, and cardiovascular mortality in end-stage renal disease. J Am Soc Nephrol 2001, 12:2117-2124.
  • [10]Mohler ER 3rd: Peripheral arterial disease: identification and implications. Arch Intern Med 2003, 163:2306-2314.
  • [11]Melian EB, Goa KL: Beraprost: a review of its pharmacology and therapeutic efficacy in the treatment of peripheral arterial disease and pulmonary arterial hypertension. Drugs 2002, 62:107-133.
  • [12]Sugawara A, Kudo M, Saito A, Matsuda K, Uruno A, Ito S: Novel effects of beraprost sodium on vasculatures. Int Angiol 2010, 29:28-32.
  • [13]Goya K, Otsuki M, Xu X, Kasayama S: Effects of the prostaglandin I2 analogue, beraprost sodium, on vascular cell adhesion molecule-1 expression in human vascular endothelial cells and circulating vascular cell adhesion molecule-1 level in patients with type 2 diabetes mellitus. Metabolism 2003, 52:192-198.
  • [14]Nakayama T, Hironaga T, Ishima H, Maruyama T, Masubuchi Y, Kokubun S: The prostacyclin analogue beraprost sodium prevents development of arterial stiffness in elderly patients with cerebral infarction. Prostaglandins Leukot Essent Fatty Acids 2004, 70:491-494.
  • [15]Nakayama T, Masubuchi Y, Kawauchi K, Masaki R, Hironaga T, Ishima H, Torigoe M, Shimabukuro H: Beneficial effect of beraprost sodium plus telmisartan in the prevention of arterial stiffness development in elderly patients with hypertension and cerebral infarction. Prostaglandins Leukot Essent Fatty Acids 2007, 76:309-314.
  • [16]Watanabe M, Nakashima H, Ito K, Miyake K, Saito T: Improvement of dyslipidemia in OLETF rats by the prostaglandin I(2) analog beraprost sodium. Prostaglandins Other Lipid Mediat 2010, 93:14-19.
  • [17]Sato N, Kaneko M, Tamura M, Kurumatani H: The prostacyclin analog beraprost sodium ameliorates characteristics of metabolic syndrome in obese Zucker (fatty) rats. Diabetes 2010, 59:1092-1100.
  • [18]Shin S, Kim KJ, Chang HJ, Lee BW, Yang WI, Cha BS, Choi D: The effect of oral prostaglandin analogue on painful diabetic neuropathy: a double-blind, randomized, controlled trial. Diabetes Obes Metab 2013, 15:185-188.
  • [19]Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F, Chronic Kidney Disease Epidemiology Collaboration: Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med 2006, 145:247-254.
  • [20]Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ: Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant 2010, 25:1388-1393.
  • [21]Mohler ER 3rd, Hiatt WR, Olin JW, Wade M, Jeffs R, Hirsch AT: Treatment of intermittent claudication with beraprost sodium, an orally active prostaglandin I2 analogue: a double-blinded, randomized, controlled trial. J Am Coll Cardiol 2003, 41:1679-1686.
  • [22]Galiè N, Humbert M, Vachiéry JL, Vizza CD, Kneussl M, Manes A, Sitbon O, Torbicki A, Delcroix M, Naeije R, Hoeper M, Chaouat A, Morand S, Besse B, Simonneau G, Arterial Pulmonary Hypertension and Beraprost European (ALPHABET) Study Group: Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol 2002, 39:1496-1502.
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