Bristol-Myers Squibb, Princeton, NJ, USA.
Clin Interv Aging. 2013;8:419-30. doi: 10.2147/CIA.S41246. Epub 2013 Apr 16.
To assess safety and efficacy of saxagliptin in older patients with type 2 diabetes mellitus (T2DM).
This was a post hoc analysis of pooled data from older patients (≥65 years of age) from five 24-week phase III trials: three studies of saxagliptin versus placebo as an add-on therapy to metformin, glyburide, or a thiazolidinedione; and two studies of saxagliptin versus placebo as monotherapy in drug-naïve patients. Separate analyses were conducted on one study of initial combination therapy with saxagliptin plus metformin versus metformin monotherapy in drug-naïve patients. The safety analysis population for the five-study pool included 428 patients ≥ 65 years of age with baseline glycated hemoglobin (HbA(1c)) 7.0% to 10.5% who received saxagliptin 2.5 or 5 mg or placebo, and for the study of initial combination therapy included 69 patients ≥ 65 years of age with baseline HbA(1c) 8.0% to 12.0% who received saxagliptin 5 mg in combination with metformin or metformin monotherapy. The primary efficacy endpoint was change from baseline HbA(1c).
In the five-study pool, the differences in the adjusted mean change from baseline HbA(1c) among older patients receiving saxagliptin versus placebo were -0.60% (95% confidence interval [CI], -0.99% to -0.21%) for saxagliptin 2.5 mg and -0.55% (-0.97% to -0.14%) for saxagliptin 5 mg; in the initial combination study, the difference was -1.22% (-2.27% to -0.17%) among older patients receiving saxagliptin 5 mg plus metformin versus metformin monotherapy. The results were generally similar in older and younger patients. Saxagliptin was well tolerated; the incidence and types of adverse events were similar for saxagliptin and comparators. Hypoglycemia was reported in 3.0% to 9.4% of patients receiving saxagliptin (0%-8.0% for comparators) and was confirmed (finger stick glucose ≤ 50 mg/dL, with associated symptoms) in 0% to 0.7% (0%-0.7% for comparators); hypoglycemic episodes did not vary by age category and did not require medical intervention.
Saxagliptin was effective and well tolerated, with a low risk of hypoglycemia, when used as monotherapy, add-on therapy, or initial combination therapy with metformin in older patients with T2DM.
评估沙格列汀在老年 2 型糖尿病（T2DM）患者中的安全性和疗效。
这是一项对来自五项 24 周 III 期研究的老年患者（≥65 岁）的汇总数据进行的事后分析：三项研究为沙格列汀作为二甲双胍、格列吡嗪或噻唑烷二酮的附加疗法与安慰剂的比较；两项研究为沙格列汀作为新诊断患者的单独疗法与安慰剂的比较。还对一项新诊断患者沙格列汀联合二甲双胍与二甲双胍单药治疗的初始联合治疗研究进行了单独分析。五项研究汇总的安全性分析人群包括基线糖化血红蛋白（HbA1c）为 7.0%至 10.5%、接受沙格列汀 2.5 或 5mg 或安慰剂治疗的 428 例年龄≥65 岁的患者，初始联合治疗研究包括基线 HbA1c 为 8.0%至 12.0%、接受沙格列汀 5mg 联合二甲双胍或二甲双胍单药治疗的 69 例年龄≥65 岁的患者。主要疗效终点为基线 HbA1c 的变化。
在五项研究汇总中，与安慰剂相比，接受沙格列汀治疗的老年患者的调整后平均 HbA1c 基线变化分别为：沙格列汀 2.5mg 组为-0.60%（95%置信区间[CI]：-0.99%至-0.21%），沙格列汀 5mg 组为-0.55%（-0.97%至-0.14%）；在初始联合研究中，接受沙格列汀 5mg 联合二甲双胍治疗的老年患者与接受二甲双胍单药治疗的患者之间的差异为-1.22%（-2.27%至-0.17%）。在老年患者和年轻患者中，结果基本相似。沙格列汀耐受性良好；沙格列汀与对照药物的不良事件发生率和类型相似。接受沙格列汀治疗的患者低血糖发生率为 3.0%至 9.4%（对照药物为 0%-8.0%），经证实（指尖血糖≤50mg/dL，伴有相关症状）的低血糖发生率为 0%至 0.7%（对照药物为 0%-0.7%）；低血糖发作的发生与年龄类别无关，且无需医疗干预。
在老年 T2DM 患者中，沙格列汀作为单药、附加疗法或与二甲双胍的初始联合治疗，疗效确切，且低血糖风险低，耐受性良好。
