Merck Sharp & Dohme Corp., Whitehouse Station, NJ 07065, USA.
Am J Kidney Dis. 2013 Apr;61(4):579-87. doi: 10.1053/j.ajkd.2012.11.043. Epub 2013 Jan 24.
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.
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 A1c (HbA1c) level of 7%-9% were randomly assigned 1:1 to treatment.
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).
Primary end points were 54-week change in HbA1c level from baseline and tolerability with sitagliptin. A secondary end point was the comparison of sitagliptin versus glipizide on the incidence of symptomatic hypoglycemia.
Of 129 patients randomly assigned, 64 were in the sitagliptin group (mean baseline age, 61 years; HbA1c, 7.9%) and 65 were in the glipizide group (mean baseline age, 59 years; HbA1c, 7.8%). After 54 weeks, the least squares mean change from baseline in HbA1c 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).
Small sample size limits between-group comparisons.
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.
尚未充分描述口服抗高血糖药物在 2 型糖尿病和终末期肾病（ESRD）患者中的治疗效果。本研究评估了西他列汀和格列吡嗪单药治疗正在接受透析治疗的 2 型糖尿病和 ESRD 患者的疗效和安全性。
54 周、随机、双盲、平行臂研究。
来自 12 个国家的 31 个临床站点，纳入了年龄在 30 岁及以上、患有 2 型糖尿病和 ESRD 且正在接受透析治疗、糖化血红蛋白（HbA1c）水平为 7%-9%的 129 例患者，将其随机分为 1:1 两组进行治疗。
西他列汀单药治疗，每日 25mg；或格列吡嗪（起始剂量为每日 2.5mg，可滴定至最大潜在剂量每日 2 次 10mg，或下调剂量以避免低血糖）。
54 周时自基线的 HbA1c 水平变化和西他列汀的耐受性为主要终点。次要终点为比较西他列汀与格列吡嗪在症状性低血糖发生率方面的差异。
129 例随机分配的患者中，64 例进入西他列汀组（平均基线年龄 61 岁，HbA1c 7.9%），65 例进入格列吡嗪组（平均基线年龄 59 岁，HbA1c 7.8%）。54 周后，西他列汀组自基线的 HbA1c 水平最小平方均值变化为-0.72%（95%CI，-0.95%至-0.48%），格列吡嗪组为-0.87%（95%CI，-1.11%至-0.63%），两组间差值为 0.15%（95%CI，-0.18%至 0.49%）。症状性低血糖和严重低血糖的发生率分别为 6.3%和 10.8%（组间差异为-4.8%[95%CI，-15.7%至 5.6%]）和 0%和 7.7%（组间差异为-7.8%[95%CI，-17.1%至-1.9%]）。与格列吡嗪相比，西他列汀组更常见（95%CI 上下限不包括治疗组间差异）细胞炎和头痛（分别为 6.3%和 0%）。
小样本量限制了组间比较。
在接受透析治疗的 2 型糖尿病和 ESRD 患者中，西他列汀或格列吡嗪单药治疗 54 周有效且耐受良好。
