比较 2 型糖尿病伴轻度肾功能不全患者使用西格列汀或磺脲类药物的治疗效果：临床试验的事后分析。
Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials.
机构信息
Merck & Co., Inc., Whitehouse Station, NJ, USA,
出版信息
Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.
INTRODUCTION
Impaired renal function is a major complication of type 2 diabetes mellitus (T2DM). Mild renal impairment is present in 38% of patients with T2DM and may impact choice of antihyperglycemic agent. Sulfonylureas and dipeptidyl peptidase-4 (DPP-4) inhibitors are commonly used to treat hyperglycemia in patients with T2DM and renal impairment. Although in general sulfonylurea use is associated with an increased risk of hypoglycemia and weight gain, while DPP-4 inhibitor use is associated with a low risk of hypoglycemia, and is weight neutral, the relative efficacy and tolerability of these agents in patients with mild renal impairment has not been evaluated.
METHODS
In a post hoc analysis, data from 1,211 subjects with T2DM and mild renal impairment (estimated glomerular filtration rates of 60 to <90 mL/min/1.73 m(2)), who completed 25 or 30 weeks of one of three double-blind clinical trials comparing the DPP-4 inhibitor sitagliptin 100 mg/day with sulfonylureas in titrated doses, were pooled. The analysis compared change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), body weight, incidence of symptomatic hypoglycemia and the percentages of subjects meeting a composite endpoint of HbA1c decrease >0.5% without symptomatic hypoglycemia or body weight gain between sitagliptin and sulfonylurea treatment groups.
RESULTS
HbA1c and FPG decreased similarly with sitagliptin or sulfonylurea. A lower incidence of hypoglycemia was observed with sitagliptin. Body weight decreased with sitagliptin but increased with sulfonylurea. A greater percentage of subjects treated with sitagliptin (41.1%) than treated with sulfonylurea (16.9%) achieved the composite endpoint of >0.5% HbA1c reduction with no symptomatic hypoglycemia or body weight gain.
CONCLUSION
In this analysis of subjects with T2DM and mild renal impairment, treatment with sitagliptin provided glycemic efficacy similar to sulfonylurea, with less hypoglycemia and with body weight loss compared to body weight gain seen with sulfonylurea.
TRIAL REGISTRATIONS
ClinicalTrials.gov #NCT00482079, #NCT00094770, #NCT00701090.
简介
肾功能受损是 2 型糖尿病（T2DM）的主要并发症。38%的 T2DM 患者存在轻度肾功能损害，这可能会影响抗高血糖药物的选择。磺酰脲类药物和二肽基肽酶-4（DPP-4）抑制剂常用于治疗 T2DM 和肾功能损害患者的高血糖。虽然磺酰脲类药物的一般使用与低血糖和体重增加的风险增加有关，而 DPP-4 抑制剂的使用与低血糖风险低和体重中性有关，但这些药物在轻度肾功能损害患者中的相对疗效和耐受性尚未得到评估。
方法
在一项事后分析中，共纳入 1211 例 T2DM 合并轻度肾功能损害（估计肾小球滤过率 60 至<90 ml/min/1.73 m 2 ）的患者，这些患者完成了三项双盲临床试验中的 25 或 30 周治疗，分别比较 DPP-4 抑制剂西他列汀 100mg/天与剂量滴定的磺酰脲类药物的疗效。该分析比较了基线时糖化血红蛋白（HbA1c）、空腹血糖（FPG）、体重、症状性低血糖发生率以及 HbA1c 降低>0.5%且无症状性低血糖或体重增加的复合终点发生率的变化，该复合终点在西他列汀和磺酰脲治疗组之间的差异。
结果
HbA1c 和 FPG 降低与西他列汀或磺酰脲类药物相似。西他列汀治疗低血糖发生率较低。西他列汀治疗体重下降，磺酰脲治疗体重增加。与接受磺酰脲治疗的患者（16.9%）相比，接受西他列汀治疗的患者（41.1%）达到复合终点的比例更高，即 HbA1c 降低>0.5%且无症状性低血糖或体重增加。
结论
在这项对 T2DM 合并轻度肾功能损害患者的分析中，与磺酰脲类药物相比，西他列汀治疗提供了相似的血糖疗效，低血糖发生率更低，体重减轻，而磺酰脲类药物治疗则体重增加。
试验注册
ClinicalTrials.gov #NCT00482079、#NCT00094770、#NCT00701090。
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