2015年第75届美国糖尿病协会（ADA）科学年会正在美国波士顿召开。会上公布了一项关于
在美国，2型糖尿病是慢性肾病（CKD）的主要诱因，有证据显示约40%的2型糖尿病患者发生CKD。2014年ADA年会公布的SAVOR研究（入组总人数16492人，其中亚裔含中国1800人）数据显示：沙格列汀组微量
本次研究的有效性数据来自9项为期24周的随机、安慰剂对照临床试验。安全性数据来自20项随机试验，试验时间范围4~206周。大多数患者为65岁以下女性；半数患者2型糖尿病病史≥5年。
经校正后，沙格列汀2.5mg和5mg组平均HbA1c较基线的降幅显著高于对照组（图1）。同时沙格列汀 2.5mg、5mg组的餐后2小时血糖（PPG）及空腹血糖（FPG）降幅、HbA1c<7%的患者比例均高于对照组。沙格列汀 5mg组与安慰剂组的低血糖发生率和严重不良事件发生率相仿（图2）。上述结果提示沙格列汀可改善血糖控制，且在2型糖尿病合并中度CKD患者中耐受良好。
既往研究已证实沙格列汀不增加心血管风险、低血糖风险低、不增加骨折风险，本次研究进一步证实了沙格列汀对中度肾功能不全患者的安全性与有效性，这些安全性数据有助于提高临床医生对DPP-4抑制剂的使用信心，为更多糖尿病患者临床用药和指南更新提供依据。
【研究摘要】
| Abstract Number: | 1270-P |
| Title: | Saxagliptin Efficacy and Safety in Patients with Moderate Renal Impairment |
| Authors: | SHIRA PERL, WILLIAM COOK, CHERYL WEI, NAYYAR IQBAL, BOAZ HIRSHBERG, Gaithersburg, MD, Princeton, NJ |
| Abstract: | Type 2 diabetes (T2D) is the leading cause of chronic kidney disease (CKD) in the U.S. with estimates suggesting that ~40% of individuals with T2D have some evidence of CKD. A recent analysis of the NHANES (1999-2012) database reported that 12.9% of T2D patients had estimated glomerular filtration rates (eGFR) in the upper range of moderate CKD (>45 and <60 mL/min/1.73 m 2 ). The recommended dose of saxagliptin (SAXA) is 2.5 mg in patients with moderate or severe renal impairment. In this post hoc analysis, we assessed the effect of SAXA 2.5 and 5 mg vs. control on glycemic measures in patients with T2D and eGFR 45-60mL/min/1.73m 2 as measured by MDRD. Efficacy data were pooled from 9, 24-week, randomized, placebo-controlled clinical trials, and safety was assessed in a pool of 20 randomized trials with data from 4-206 weeks. The majority of patients were women aged <65 years; half of the patients had a T2D duration ≥5 years (Table). Adjusted mean change from baseline in A1C was reduced to a significantly greater extent with SAXA 2.5 and 5 mg vs. control (Table). There were numerically greater reductions in 2-hour postprandial glucose (PPG) and fasting plasma glucose (FPG) and a greater proportion of patients achieved A1C <7% with SAXA 2.5 and 5 mg vs. control. Incidence of hypoglycemia was similar across treatment groups. These results suggest that SAXA improves glycemic control and is generally well tolerated in patients with T2D and moderate CKD. |
会议专题>>>2015年美国糖尿病协会（ADA）年会
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