Raji Annaswamy, Xu Zhi Jin, Lam Raymond L H, O'Neill Edward A, Kaufman Keith D, Engel Samuel S
Merck & Co., Inc., Kenilworth, NJ, USA.
Diabetes Ther. 2020 Oct;11(10):2419-2428. doi: 10.1007/s13300-020-00907-w. Epub 2020 Aug 27.
Older patients with type 2 diabetes (T2D) are at increased risk of diabetic nephropathy and mild renal insufficiency. This analysis compared the anti-hyperglycemic efficacy and safety of sitagliptin with dapagliflozin in patients ≥ 65 years of age with T2D and mild renal insufficiency.
This was a post hoc analysis of data from 410 patients ≥ 65 years old who participated in a 24-week, randomized, double-blind clinical trial (CompoSIT-R [comparison of sitagliptin with dapagliflozin in mild renal impairment]; NCT02532855) in T2D patients with mild renal insufficiency and on metformin ± a sulfonylurea; the primary efficacy end point was change in HbA1c at week 24.
Treatment groups were well balanced at baseline (mean HbA1c = 7.7/7.7% and eGFR = 79/76 ml/min/1.73 m for sitagliptin/dapagliflozin). At week 24, LS mean (95% CI) change in HbA1c and percentage of patients with HbA1c < 7% were greater with sitagliptin, - 0.48% and 41%, respectively, compared with dapagliflozin, - 0.36% and 28%; between-group differences = - 0.12% (- 0.36, 0.01) and 12.8% (3.3, 22.2) for change in HbA1c and percentage with HbA1c < 7%, respectively. The sitagliptin group had greater reductions in PPG end points, while the dapagliflozin group had greater reductions in FPG. Treatments were generally well tolerated. There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
In patients ≥ 65 years of age with T2D and mild renal insufficiency with inadequate glycemic control on metformin ± sulfonylurea, treatment with sitagliptin for 24 weeks resulted in improvement in HbA1c relative to treatment with dapagliflozin that is consistent with that previously observed in the overall population. Both treatments were generally well tolerated.
老年2型糖尿病（T2D）患者发生糖尿病肾病和轻度肾功能不全的风险增加。本分析比较了西他列汀与达格列净在≥65岁T2D合并轻度肾功能不全患者中的降糖疗效和安全性。
这是一项对410例≥65岁患者的数据进行的事后分析，这些患者参与了一项针对轻度肾功能不全且正在使用二甲双胍±磺脲类药物的T2D患者的为期24周的随机双盲临床试验（CompoSIT-R[西他列汀与达格列净在轻度肾功能损害中的比较]；NCT02532855）；主要疗效终点是第24周时糖化血红蛋白（HbA1c）的变化。
治疗组在基线时均衡性良好（西他列汀/达格列净组的平均HbA1c分别为7.7%/7.7%，估算肾小球滤过率[eGFR]分别为79/76 ml/min/1.73m²）。在第24周时，西他列汀组HbA1c的最小二乘均值（95%置信区间）变化和HbA1c<7%的患者百分比分别为-0.48%和41%，优于达格列净组的-0.36%和28%；HbA1c变化和HbA1c<7%患者百分比的组间差异分别为-0.12%（-0.36，0.01）和12.8%（3.3，22.2）。西他列汀组餐后血糖（PPG）终点降低幅度更大，而达格列净组空腹血糖（FPG）降低幅度更大。治疗总体耐受性良好。西他列汀组与药物相关的不良事件（AE）比达格列净组少，但AE谱在其他方面相似。
在≥65岁T2D合并轻度肾功能不全且使用二甲双胍±磺脲类药物血糖控制不佳的患者中，与达格列净治疗相比，西他列汀治疗24周可使HbA1c得到改善，这与先前在总体人群中观察到的结果一致。两种治疗总体耐受性良好。
