Chaudhuri Sailayee, Biswas Supreeti, Mukhopadhyay Sandip, Dasgupta Somnath
Department of Pharmacology, MJN Medical College and Hospital, Coochbehar, West Bengal, India.
Department of Pharmacology, Burdwan Medical College, Burdwan, West Bengal, India.
Indian J Pharmacol. 2025 Jul 1;57(4):254-261. doi: 10.4103/ijp.ijp_492_24. Epub 2025 Jul 21.
Dipeptidyl peptidase 4 (DPP-4) inhibitors are primarily excreted renally. Linagliptin is an exception with excretion primarily through enterohepatic system and is expected to have a better renal profile, though real-world data are scarce. Comparative studies on the renal safety and glycaemic control with linagliptin versus popular DPP-4 inhibitors such as vildagliptin are crucial, especially in the background of COVID-19 pandemic that hugely impacted glycemic control in India's large type 2 diabetes mellitus (T2DM) population.
Adult T2DM patients not controlled with metformin alone, added linagliptin (5 mg once daily) or vildagliptin (50 mg twice daily) in the tertiary care outpatient department setting were included in the study. Parameters such as glycosylated hemoglobin, fasting blood glucose, postprandial blood glucose, blood urea nitrogen, serum creatinine, estimated glomerular filtration rate (eGFR), change in renal function, glycemic control, and clinical parameters were compared at baseline, 2 months, and 6 months of treatment. All adverse events were analyzed using the WHO-UMC scale.
Both groups achieved similar glycemic control, however, accompanied with impairment of renal parameters after 6 months. Compared to linagliptin, almost 300% rise in creatinine and 140% fall in eGFR were noted in the vildagliptin recipients. However, the difference in serum creatinine or eGFR could not attain statistical significance in the study.
Both linagliptin and vildagliptin can help to achieve glycemic control despite possible influence of the COVID-19 pandemic and are generally well tolerated. However, renal functions are better preserved with linagliptin. Further studies involving a larger sample size and longer follow-up are recommended before generalization of the findings of the present study.
二肽基肽酶4(DPP-4)抑制剂主要经肾脏排泄。利那格列汀是个例外,其排泄主要通过肠肝系统,预计具有更好的肾脏安全性,尽管实际数据较少。比较利那格列汀与常用DPP-4抑制剂(如维格列汀)在肾脏安全性和血糖控制方面的研究至关重要,尤其是在新冠疫情对印度大量2型糖尿病(T2DM)患者血糖控制产生巨大影响的背景下。
本研究纳入了在三级医疗门诊环境中,单独使用二甲双胍血糖控制不佳,加用利那格列汀(每日一次,每次5mg)或维格列汀(每日两次,每次50mg)的成年T2DM患者。在治疗的基线、2个月和6个月时,比较糖化血红蛋白、空腹血糖、餐后血糖、血尿素氮、血清肌酐、估算肾小球滤过率(eGFR)、肾功能变化、血糖控制情况以及临床参数等指标。使用世界卫生组织药物不良反应监测中心(WHO-UMC)量表分析所有不良事件。
两组患者血糖控制情况相似,但6个月后均出现肾脏参数受损。与利那格列汀组相比,维格列汀组患者肌酐升高近300%,eGFR下降140%。然而,血清肌酐或eGFR的差异在本研究中未达到统计学意义。
尽管受到新冠疫情的可能影响,利那格列汀和维格列汀均有助于实现血糖控制,且总体耐受性良好。然而,利那格列汀对肾功能的保护更好。在本研究结果推广之前,建议进行样本量更大、随访时间更长的进一步研究。