Hao Zhaohu, Huang Xiao, Shao Hailin, Tian Fengshi
Department of Metabolic Disease Management Center, Tianjin 4th Central Hospital, Tianjin, China,
NHC Key Laboratory of Hormones and Development (Tianjin Medical University), Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Metabolic Diseases Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.
Ther Clin Risk Manag. 2018 Dec 11;14:2407-2413. doi: 10.2147/TCRM.S186347. eCollection 2018.
Raised serum uric acid (SUA) level is commonly observed in patients with type 2 diabetes mellitus (T2DM) and is associated with increased morbidity and mortality. Sodium-glucose cotransporter 2 inhibitor, a novel oral diabetic drug, might exert a potential hypouricemic effect. We evaluated the effects of dapagliflozin on SUA levels in hospitalized T2DM patients with inadequate glycemic control.
In this randomized controlled trial, 59 T2DM hospitalized patients with inadequate glycemic control were assigned to the dapagliflozin 10 mg group (n=29) or the control group (n=30). The primary outcome was changes in SUA levels from the baseline to good glycemic control. Additional outcomes included correlations between baseline SUA levels, urinary parameters, and the changes in SUA levels. This trial is registered in the Chinese Clinical Trial Registry (number ChiCTR1800015830).
Compared to baseline level, SUA levels had significantly decreased in both groups (<0.001 for the dapagliflozin group and =0.013 for the control group). Mean changes from baseline in SUA levels for dapagliflozin vs the control group were 68.03 vs 25.90 μmol/L (=0.0406). Adjusted mean SUA levels were lower in the dapagliflozin group (273.28 vs 307.57 μmol/L; =0.0089). In T2DM patients treated with dapagliflozin, the decrease in SUA levels was positively correlated with baseline SUA levels (<0.0001) but not correlated with changes in 24-hour urine volume, 24-hour urine glucose, or 24-hour urinary uric acid.
Dapagliflozin could improve glycemic control and lower SUA levels in hospitalized patients with uncontrolled T2DM. Longer-time trials are required to further demonstrate the hypouricemic effect of dapagliflozin and explore the potential underlying mechanisms.
2型糖尿病（T2DM）患者中血清尿酸（SUA）水平升高较为常见，且与发病率和死亡率增加相关。钠-葡萄糖协同转运蛋白2抑制剂作为一种新型口服降糖药物，可能具有潜在的降尿酸作用。我们评估了达格列净对血糖控制不佳的住院T2DM患者SUA水平的影响。
在这项随机对照试验中，59例血糖控制不佳的住院T2DM患者被分为达格列净10 mg组（n = 29）和对照组（n = 30）。主要结局是从基线到血糖良好控制时SUA水平的变化。其他结局包括基线SUA水平、尿液参数与SUA水平变化之间的相关性。本试验已在中国临床试验注册中心注册（注册号ChiCTR1800015830）。
与基线水平相比，两组的SUA水平均显著降低（达格列净组P<0.001，对照组P = 0.013）。达格列净组与对照组SUA水平相对于基线的平均变化分别为68.03 μmol/L和25.90 μmol/L（P = 0.0406）。达格列净组的校正平均SUA水平较低（273.28 μmol/L对307.57 μmol/L；P = 0.0089）。在接受达格列净治疗的T2DM患者中，SUA水平的降低与基线SUA水平呈正相关（P<0.0001），但与24小时尿量、24小时尿糖或24小时尿尿酸的变化无关。
达格列净可改善血糖控制不佳的住院T2DM患者的血糖水平并降低SUA水平。需要进行更长时间的试验以进一步证明达格列净的降尿酸作用并探索潜在的机制。
