Efficacy and Safety of Sitagliptin in Patients With Type 2 Diabetes and ESRD Receiving Dialysis: A 54-Week Randomized Trial
Efficacy and Safety of Sitagliptin in Patients With Type 2 Diabetes and ESRD Receiving Dialysis: A 54-Week Randomized Trial
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DOI：
10.1053/j.ajkd.2012.11.043
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发表时间：
2013-04-01
影响因子：
13.2
通讯作者：
Goldstein, Barry J.
中科院分区：
文献类型：
--
作者：
Ferreira, Juan C. Arjona;Corry, Dalila;Goldstein, Barry J.
背景资料：口服降糖药治疗在2型糖尿病和终末期肾病（ESRD）患者中尚未得到很好的表征。本研究评估了西格列汀和格列吡嗪单药治疗2型糖尿病合并ESRD患者透析治疗的疗效和安全性。研究设计：54周、随机、双盲、平行组研究。来自12个国家的31个临床研究中心，129名30岁或以上正在接受透析治疗且血红蛋白A（1c）（HbA（1c））水平为7%-9%的2型糖尿病和ESRD患者被随机分配为1：干预：西格列汀25 mg/d或格列吡嗪单药治疗（起始剂量为2.5 mg/d，最大剂量为10 mg/d，或减少剂量以避免低血糖）。结果：主要终点为54周时HbA（1c）水平较基线的变化和西格列汀的耐受性。次要终点是比较西格列汀与格列吡嗪对症状性低血糖的发生率。结果：129例患者随机分配，64人在西格列汀组（平均基线年龄，61岁; HbA（1c），7.9%）和65人在格列吡嗪组（平均基线年龄，59岁; HbA（1c），7.8%）。54周后，西格列汀组HbA（1c）水平较基线的最小二乘平均变化为-0.72%（95% CI，-0.95%至0.48%），格列吡嗪组为-0.87%（95% CI，-1.11%至0.63%），差异为0.15%（95% CI，-0.18%至0.49%）。西格列汀组和格列吡嗪组症状性低血糖和重度低血糖的发生率分别为6.3%和10.8%（组间差异，-4.8% [95% CI，-15.7%至5.6%]），0%和7.7%（组间差异，-7.8% [95% CI，-17.1%至1.9%]）。发生率较高与格列吡嗪相比，西格列汀组发现蜂窝织炎和头痛（即，治疗间差异的95% CI不包括0）（两者分别为6.3%和0%）。局限性：样本量小限制了组间比较。结论：西格列汀或格列吡嗪单药治疗在54周内对2型糖尿病和ESRD患者有效且耐受性良好，接受透析美国肾脏病杂志61（4）：579-587。(C)2013年，美国国家肾脏基金会（National Kidney Foundation，Inc.）
Background: Treatment with oral antihyperglycemic agents has not been well characterized in patients with type 2 diabetes and end-stage renal disease (ESRD). The efficacy and safety of sitagliptin and glipizide monotherapy in patients with type 2 diabetes and ESRD on dialysis therapy were assessed in this study.Study Design: 54-week, randomized, double-blind, parallel-arm study.Setting & Participants: From 31 clinical sites in 12 countries, 129 patients 30 years or older with type 2 diabetes and ESRD who were on dialysis therapy and had a hemoglobin A(1c) (HbA(1c)) level of 7%-9% were randomly assigned 1: 1 to treatment.Intervention: Monotherapy with sitagliptin, 25 mg daily or glipizide (initiated with 2.5 mg daily and titrated up to a potential maximum dose of 10 mg twice daily or down to avoid hypoglycemia).Outcomes: Primary end points were 54-week change in HbA(1c) level from baseline and tolerability with sitagliptin. A secondary end point was the comparison of sitagliptin versus glipizide on the incidence of symptomatic hypoglycemia.Results: Of 129 patients randomly assigned, 64 were in the sitagliptin group (mean baseline age, 61 years; HbA(1c), 7.9%) and 65 were in the glipizide group (mean baseline age, 59 years; HbA(1c), 7.8%). After 54 weeks, the least squares mean change from baseline in HbA(1c) level was -0.72% (95% CI, -0.95% to -0.48%) with sitagliptin and -0.87% (95% CI, -1.11% to -0.63%) with glipizide, for a difference of 0.15% (95% CI, -0.18% to 0.49%). The incidences of symptomatic hypoglycemia and severe hypoglycemia were 6.3% versus 10.8% (between-group difference, -4.8% [95% CI, -15.7% to 5.6%]) and 0% versus 7.7% (between-group difference, -7.8% [95% CI, -17.1% to -1.9%]) in the sitagliptin and glipizide groups, respectively. Higher incidences (ie, 95% CI around between-treatment difference excluded 0) of cellulitis and headache were found with sitagliptin compared to glipizide (6.3% vs 0%, respectively, for both).Limitations: Small sample size limits between-group comparisons.Conclusions: Treatment with sitagliptin or glipizide monotherapy was effective and well tolerated over 54 weeks in patients with type 2 diabetes and ESRD who were receiving dialysis. Am J Kidney Dis. 61(4): 579-587. (C) 2013 by the National Kidney Foundation, Inc.