Md Faruque Pathan, Nazma Akter, Marufa Mustari, M Saifuddin, Mirza Sharifuzzaman, Mohammad Motiur Rahman, Mohammed Ripon, S M Mohiuddin, A B M Kamrul-Hasan, Mohammad Abdul Hannan, Muhammad Shah Alam, Samira Mahjabeen, Faria Afsana, Muhammed Abu Bakar, Tahniyah Haq, Afsar Ahammed, Samir Kumar Talukder, Sourav Sarkar, Shahjada Selim
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引用次数: 0
Abstract
Background: Management of type 2 diabetes mellitus (T2DM) during Ramadan fasting presents unique challenges due to prolonged fasting periods, irregular meal schedules, and altered medication timing, potentially impacting glycemic control. Ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to improve glycemic control in T2DM effectively. However, the effectiveness of ertugliflozin during Ramadan fasting, a period with unique glycemic challenges, has not been studied extensively.
Methods: This study was a multicenter, real-life experience study involving 1373 adult patients with known T2DM for at least one year, an HbA1c level of less than 10%, and who intended to fast during Ramadan. Participants were divided into two groups: the Ertu group (n=703), consisting of patients who had been on a stable dose of ertugliflozin for at least three months before Ramadan, and the non-Ertu group (n=670), which included patients receiving other oral antihyperglycemic drugs (OADs) except ertugliflozin. Patients attended a baseline visit one month before the first day of Ramadan and a follow-up visit within one month after the last day of Ramadan. Both visits included history taking, physical examinations, and laboratory tests. The primary endpoints were changes in HbA1c levels, body weight, body mass index (BMI), and the incidence of hypoglycemia during Ramadan fasting.
Results: The mean age of the study participants was 50.37 ± 11.14 (SD) years, with 40.6% male and 58.7% female. Patients receiving ertugliflozin showed significant reduction in HbA1C (-0.65 ± 0.67% vs. -0.22 ± 0.64%, p<0.001), body weight (-1.24 ± 2.58 kg vs. -0.36 ± 3.41 kg, p<0.001), and BMI (-0.48 ± 1.03 kg/m² vs. -0.11 ± 1.33 kg/m², p<0.001) compared to the non-Ertu group. Hypoglycemia was reported in 0.3% of the ertugliflozin group and 0.7% of the other group, with comparable adverse events (p=.23; ≥0.05), indicating a favorable safety profile for ertugliflozin during fasting.
Conclusion: This study demonstrates that ertugliflozin is effective and safe for patients with T2DM during Ramadan fasting.
背景：2型糖尿病（T2DM）在斋月禁食期间的管理面临着独特的挑战，因为禁食时间延长，不规律的饮食计划和改变的用药时间，潜在地影响血糖控制。埃图格列净是一种钠-葡萄糖共转运蛋白2 （SGLT2）抑制剂，已被证明可有效改善T2DM患者的血糖控制。然而，埃图列净在斋月禁食期间的有效性尚未得到广泛研究，斋月是一个具有独特血糖挑战的时期。方法：本研究是一项多中心、真实体验研究，涉及1373例已知T2DM至少一年、HbA1c水平低于10%、打算在斋月期间禁食的成年患者。参与者被分为两组：Ertu组（n=703），包括在斋月前至少三个月服用稳定剂量的厄图列净的患者；非Ertu组（n=670），包括服用除厄图列净以外的其他口服降糖药（oad）的患者。患者在斋月第一天前一个月进行基线访问，并在斋月最后一天后一个月内进行随访。两次访问都包括病史记录、体格检查和实验室检查。主要终点是斋月禁食期间HbA1c水平、体重、体重指数（BMI）和低血糖发生率的变化。结果：研究参与者的平均年龄为50.37±11.14 （SD）岁，其中男性占40.6%，女性占58.7%。接受厄图列净治疗的T2DM患者HbA1C显著降低（-0.65±0.67% vs -0.22±0.64%）。结论：本研究表明厄图列净对斋月禁食期间T2DM患者有效且安全。
期刊介绍：
Frontiers in Endocrinology is a field journal of the "Frontiers in" journal series.
In today’s world, endocrinology is becoming increasingly important as it underlies many of the challenges societies face - from obesity and diabetes to reproduction, population control and aging. Endocrinology covers a broad field from basic molecular and cellular communication through to clinical care and some of the most crucial public health issues. The journal, thus, welcomes outstanding contributions in any domain of endocrinology.
Frontiers in Endocrinology publishes articles on the most outstanding discoveries across a wide research spectrum of Endocrinology. The mission of Frontiers in Endocrinology is to bring all relevant Endocrinology areas together on a single platform.
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