Goldshtein Inbal, Karasik Avraham, Melzer-Cohen Cheli, Engel Samuel S, Yu Shengsheng, Sharon Ofer, Brodovicz Kimberly, Gadir Noga, Katzeff Harvey L, Radican Larry, Chodick Gabriel, Shalev Varda, Tunceli Kaan
Maccabi Healthcare Services, Tel Aviv, Israel.
Sheba Medical Center, Tel Hashomer, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
J Diabetes Complications. 2016 Sep-Oct;30(7):1354-9. doi: 10.1016/j.jdiacomp.2016.05.012. Epub 2016 May 17.
To compare the change in urinary albumin to creatinine ratio (UACR) in type 2 diabetes (T2DM) patients with albuminuria who initiate sitagliptin to those who initiate a sulfonylurea (SU) as add-on to metformin monotherapy.
A cohort of T2DM patients with albuminuria (UACR >30mg/g) who initiated sitagliptin or SU as add-on dual therapy to metformin between 2008 and 2014 was extracted from the computerized medical records of a large managed care organization in Israel. Patients with albuminuria and UACR measurements available at treatment initiation and 120-365days afterwards were included. Propensity scores were calculated based on 17 factors, including demography, comorbidities, baseline levels of HbA1c, UACR, BMI, eGFR, and ACE/ARB use, and patients were matched in a 1:1 ratio. Changes in UACR were compared between the matched pairs using generalized estimating equations.
A total of 282 eligible pairs (sitagliptin:SU) were identified. During a mean follow-up of 9months, median UACR changes were -35% (IQR=-73% to 5%) and -31% (IQR=-72% to 21%) in the sitagliptin and SU groups, respectively. Mean absolute HbA1c reductions among sitagliptin and SU groups were 0.9% and 1.0%, respectively. The magnitude of UACR reduction generally increased with greater magnitude of HbA1c reduction in both treatment groups. However, after controlling for HbA1c reduction and the interaction between HbA1c reduction and UACR reduction, sitagliptin users demonstrated a trend toward an increased likelihood of UACR reduction compared to SU users (odds ratio=1.20; 95% confidence interval: 0.99-1.47, P=0.063).
Our results suggest that both sitagliptin and SU reduce albuminuria as an add-on therapy to metformin, but that sitagliptin may provide greater reductions in albuminuria independent of glycemic control when compared to SU. Larger population studies are required to further explore this.
比较起始使用西格列汀的2型糖尿病（T2DM）蛋白尿患者与起始使用磺脲类药物（SU）作为二甲双胍单药治疗附加药物的患者尿白蛋白与肌酐比值（UACR）的变化。
从以色列一家大型管理式医疗组织的计算机化医疗记录中提取2008年至2014年间起始使用西格列汀或SU作为二甲双胍附加双药治疗的T2DM蛋白尿患者队列（UACR>30mg/g）。纳入在治疗开始时及之后120 - 365天有蛋白尿和UACR测量值的患者。根据17个因素计算倾向得分，包括人口统计学、合并症、糖化血红蛋白（HbA1c）、UACR、体重指数（BMI）、估算肾小球滤过率（eGFR）的基线水平以及血管紧张素转换酶抑制剂/血管紧张素Ⅱ受体阻滞剂（ACE/ARB）的使用情况，并按1:1的比例对患者进行匹配。使用广义估计方程比较匹配对之间UACR的变化。
共确定了282对符合条件的配对（西格列汀：SU）。在平均9个月的随访期间，西格列汀组和SU组的UACR中位数变化分别为-35%（四分位间距[IQR]=-73%至5%）和-31%（IQR=-72%至21%）。西格列汀组和SU组的平均HbA1c绝对降低值分别为0.9%和1.0%。在两个治疗组中，UACR降低的幅度通常随HbA1c降低幅度的增大而增加。然而，在控制了HbA1c降低以及HbA1c降低与UACR降低之间的相互作用后，与SU使用者相比，西格列汀使用者的UACR降低可能性有增加的趋势（优势比=1.20；95%置信区间：0.99 - 1.47，P=0.063）。
我们的结果表明，西格列汀和SU作为二甲双胍的附加治疗均能降低蛋白尿，但与SU相比，西格列汀在独立于血糖控制的情况下可能能更大程度地降低蛋白尿。需要更大规模的人群研究来进一步探索这一点。
