Moon Sun Joon, Ahn Chang Ho, Cho Young Min
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
PLoS One. 2017 Apr 11;12(4):e0175334. doi: 10.1371/journal.pone.0175334. eCollection 2017.
The metformin label has recently been changed from serum creatinine (sCr)-based to estimated glomerular filtration rate (eGFR)-based indication, which is expected to expand its use for patients with mild renal insufficiency. However, because the sCr level is lower in Asians than in Caucasians at the same level of renal function, this change might not expand metformin use in the Asian population. We investigated the effect of this change among Korean patients with diabetes.
Data from the Korean National Health and Nutrition Examination Survey 2009 to 2014 were used and included 4,127 adult patients with diabetes. The metformin eligibility was assessed by the sCr level (1.4 mg/dL for women and 1.5 mg/dL for men) or by eGFR categories (contraindicated, <30; indeterminate, ≥30, <45; likely safe, ≥45 mL/min/1.73 m2) calculated by various eGFR equations including MDRD equation. We designated the 'expanding' and 'contracting' population as those who are likely safe according to eGFR among sCr-ineligible patients and those contraindicated according to eGFR among sCr-eligible patients, respectively. Results were weighted to the whole Korean adult population.
All eGFR equations showed expansion in the population for whom metformin is likely safe, ranging from 14.3% to 19.9% of the sCr-ineligible population. With the MDRD equation, the expanding population was 15,264 (15.8%) and the contracting population was 0 (0.0%). Male sex and younger age were significantly associated with the expanding population.
Contrary to our concern, prescribing metformin according to eGFR substantially expanded the indication of its use among the Korean diabetic patients.
二甲双胍的用药说明最近已从基于血清肌酐(sCr)改为基于估算肾小球滤过率(eGFR),这有望扩大其在轻度肾功能不全患者中的应用。然而,由于在相同肾功能水平下,亚洲人的血清肌酐水平低于白种人,这一变化可能不会扩大二甲双胍在亚洲人群中的使用。我们调查了这一变化对韩国糖尿病患者的影响。
使用了2009年至2014年韩国国民健康与营养检查调查的数据,其中包括4127名成年糖尿病患者。根据血清肌酐水平(女性为1.4mg/dL,男性为1.5mg/dL)或通过包括MDRD方程在内的各种估算肾小球滤过率方程计算的估算肾小球滤过率类别(禁忌,<30;不确定,≥30,<45;可能安全,≥45mL/min/1.73m²)来评估二甲双胍的适用性。我们将“扩大”和“缩小”人群分别定义为血清肌酐不适用患者中根据估算肾小球滤过率可能安全的人群以及血清肌酐适用患者中根据估算肾小球滤过率禁忌的人群。结果加权至整个韩国成年人群。
所有估算肾小球滤过率方程均显示二甲双胍可能安全的人群有所扩大,占血清肌酐不适用人群的14.3%至19.9%。使用MDRD方程时,扩大人群为15264人(15.8%),缩小人群为0人(0.0%)。男性和较年轻年龄与扩大人群显著相关。
与我们的担忧相反,根据估算肾小球滤过率开具二甲双胍处方显著扩大了其在韩国糖尿病患者中的使用指征。