Khan Arif Ullah, Sharif Muhammad Junaid Hassan, Ashfaq Muhammad, Khan Qasim, Iqbal Muhammad Mamoon, Iqbal Ayesha, Bashatah Adel, Syed Wajid, Alqahtani Naji
Department of Pharmacy, COMSATS University Islamabad, Abbottabad Campus, Abbottabad, Pakistan.
Department of Respiratory sciences, University of Leicester. University Rd, Leicester, LE1 7RH, UK.
J Health Popul Nutr. 2025 Aug 21;44(1):304. doi: 10.1186/s41043-025-01041-8.
Uncontrolled type 2 diabetes mellitus warrant the utilization of different combination antidiabetic therapies, however, the addition of these newer agents as add-on therapy increases the risk of side effects and needs to be further investigated in terms of their risk to benefit to the patient. Therefore, the current study aims to evaluate the clinical and safety outcomes in patients taking empagliflozin and Sitagliptin in addition to metformin.
A cross-sectional study was conducted using a non-probability consecutive sampling technique to gather data at the Diabetes and Foot Care Clinic in Abbottabad from July 2023 to December 2023. This is an exploratory observational study in which a total of 155 study participants were selected and divided into two groups: Group A, treated with Sitagliptin add-on Metformin (n = 79), and Group B, treated with Empagliflozin add-on Metformin (n = 76), Biochemical parameters (HbA1c, serum creatinine) were collected and eGFR was calculated at baseline and after a 3-month follow-up. All statistical analyses were performed using IBM SPSS version 23.
Among the participant's majority (53.5%) were males whereas the mean age of the participants was 51.7 ± 10.5 years. Baseline HbA1c and serum creatinine of all the patients were found to be 9.5 ± 1.8% and 1.02 ± 0.2 mg/dL respectively. There was a statistically significant decrease in mean HbA1c values in both the groups at baseline and follow-up (p < 0.001) whereas both the groups were found to be similar in their ability to reduce HbA1c (p = 0.25). Furthermore, there was a statistically significant decrease in serum creatinine values in both the groups at baseline and follow-up (p = 0.002) whereas Empagliflozin add-on Metformin was found to have more ability to reduce serum creatinine (p = 0.01) as compared to Sitagliptin add-on Metformin (p = 0.06). As a result, Empagliflozin add-on Metformin improved the patients' eGFR significantly (p = 0.001).
Empagliflozin as add on therapy in uncontrolled T2DM provided improvements in patients HbA1c, serum creatinine, and eGFR hence improving overall clinical outcomes and patient safety.
未得到控制的2型糖尿病需要采用不同的联合抗糖尿病疗法，然而，添加这些新型药物作为附加疗法会增加副作用风险，并且需要进一步研究其对患者的风险效益情况。因此，本研究旨在评估除二甲双胍外还服用恩格列净和西格列汀的患者的临床和安全性结局。
采用非概率连续抽样技术进行横断面研究，于2023年7月至2023年12月在阿伯塔巴德的糖尿病与足部护理诊所收集数据。这是一项探索性观察性研究，共选取155名研究参与者并分为两组：A组，接受西格列汀联合二甲双胍治疗（n = 79）；B组，接受恩格列净联合二甲双胍治疗（n = 76）。收集生化参数（糖化血红蛋白、血清肌酐），并在基线和3个月随访后计算估算肾小球滤过率（eGFR）。所有统计分析均使用IBM SPSS 23版软件进行。
参与者中大多数（53.5%）为男性，参与者的平均年龄为51.7±10.5岁。所有患者的基线糖化血红蛋白和血清肌酐分别为9.5±1.8%和1.02±0.2mg/dL。两组在基线和随访时的平均糖化血红蛋白值均有统计学显著下降（p < 0.001），而两组在降低糖化血红蛋白的能力方面相似（p = 0.25）。此外，两组在基线和随访时的血清肌酐值均有统计学显著下降（p = 0.002），然而，与西格列汀联合二甲双胍组（p = 0.06）相比，恩格列净联合二甲双胍组降低血清肌酐的能力更强（p = 0.01）。结果，恩格列净联合二甲双胍显著改善了患者的估算肾小球滤过率（p = 0.001）。
恩格列净作为未得到控制的2型糖尿病的附加疗法，可改善患者的糖化血红蛋白、血清肌酐和估算肾小球滤过率，从而改善总体临床结局和患者安全性。
