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首页> 外文期刊>Journal of Clinical Medicine Research >Efficacy and Safety of Adding Sitagliptin in Type 2 Diabetes Patients on Insulin: Age-Stratified Comparison at One Year in the ASSIST-K Study
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Efficacy and Safety of Adding Sitagliptin in Type 2 Diabetes Patients on Insulin: Age-Stratified Comparison at One Year in the ASSIST-K Study

机译：西格列汀在2型糖尿病胰岛素患者中的疗效和安全性：ASSIST-K研究中按年龄分层的一年比较

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Background: Sitagliptin, the first dipeptidyl peptidase-4 inhibitor, has demonstrated efficacy and safety as monotherapy and as add-on therapy to oral antidiabetic agents or insulin. However, there have been few reports about sitagliptin in elderly patients. The ASSIST-K observational study was performed in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin as add-on therapy to insulin. Changes of hemoglobin A1c (HbA1c), body weight, and the estimated glomerular filtration rate (eGFR), as well as adverse events, were investigated over 12 months in age-stratified groups. Methods: Among outpatients with T2DM treated at member institutions of Kanagawa Physicians Association, those starting sitagliptin as add-on therapy to insulin were followed for 12 months. HbA1c (National Glycohemoglobin Standardization Program), body weight, and eGFR were the efficacy endpoints, while adverse events were investigated to assess safety. Patients were stratified into three age groups (≤ 64 years, 65 - 74 years, and ≥ 75 years) for comparison of the endpoints. Results: Among 937 patients on insulin before starting sitagliptin, 821 patients were analyzed after excluding those without HbA1c data at baseline and 12 months. The two groups of elderly patients (65 - 74 years and ≥75 years) had more complications and their HbA1c was lower at initiation of sitagliptin therapy. The dose of sitagliptin, daily number of insulin injections, and number of concomitant oral antidiabetic agents were all lower in the elderly patients. HbA1c showed a significant decrease after initiation of sitagliptin in all age groups, and there were no significant intergroup differences in the change of HbA1c at 12 months. Body weight did not change significantly in any group. eGFR decreased significantly in all groups, with no significant intergroup differences at 12 months. Regarding adverse events, there were no significant intergroup differences in the incidence of severe hypoglycemia, gastrointestinal symptoms, or constipation. Conclusions: Despite baseline differences in demographic factors and medications, sitagliptin showed good efficacy and safety in all age groups of patients receiving it as add-on therapy to insulin during routine management of T2DM. Adding sitagliptin to insulin achieves similar efficacy and safety outcomes at 12 months in both elderly and non-elderly T2DM patients.
机译：背景：西他列汀是首个二肽基肽酶-4抑制剂，已证明作为单一疗法以及作为口服抗糖尿病药或胰岛素的附加疗法的功效和安全性。但是，关于老年患者西他列汀的报道很少。 ASSIST-K观察性研究是在接受西他列汀作为胰岛素补充治疗的2型糖尿病（T2DM）患者中进行的。在年龄分层的组中，调查了12个月内血红蛋白A1c（HbA1c），体重和估计的肾小球滤过率（eGFR）的变化以及不良事件。方法：在神奈川县医师协会会员机构门诊的T2DM门诊患者中，对开始使用西他列汀作为胰岛素附加疗法的患者进行为期12个月的随访。 HbA1c（国家糖化血红蛋白标准化计划），体重和eGFR是疗效终点，同时还调查了不良事件以评估安全性。将患者分为三个年龄段（≤64岁，65-74岁和≥75岁）进行终点比较。结果：在开始使用西他列汀前的937例胰岛素患者中，排除了基线和12个月无HbA1c数据的821例患者。两组老年患者（65-74岁和≥75岁）在西他列汀治疗开始时并发症较多，HbA1c较低。在老年患者中，西他列汀的剂量，每日注射胰岛素的数量以及伴随的口服降糖药的数量均较低。在所有年龄组中，西他列汀治疗开始后HbA1c均显着降低，并且在12个月时HbA1c的变化在组间无显着差异。体重在任何组中均无明显变化。所有组的eGFR均显着下降，在12个月时组间无显着差异。关于不良事件，严重低血糖，胃肠道症状或便秘的发生率在组间没有显着差异。结论：尽管在人口统计学因素和药物治疗方面存在基线差异，但西他列汀在接受T2DM常规治疗期间作为胰岛素的补充治疗的所有年龄组患者均显示出良好的疗效和安全性。在老年和非老年T2DM患者中，在12个月内向胰岛素中添加西他列汀可达到相似的疗效和安全性结果。

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