Efficacy of Empagliflozin as Add-on Therapy in Patients with Uncontrolled Type 2 Diabetes Mellitus

Mita Rani Joysoual, Shahin Ara, Md. Nazmul Haque, R. Ghosh, T. Afroze, Saqib Salah Aufi
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Abstract

Background: Metformin is recommended as first-line pharmacotherapy for patients with type 2 Diabetes Mellitus (T2DM) who fail to achieve glycemic control through lifestyle modification. Metformin initially lowers blood glucose, but as diabetes progresses, it alone frequently fails to maintain glycemic control, and additional therapies are required. Empagliflozin is a potent and selective sodium-glucose co-transporter 2 (SGLT2) inhibitor that is effective in reducing blood sugar levels as monotherapy or add-on to existing therapy with significant improvements in glycemic control and weight. Materials & Methods: This quasi-experimental study was conducted in the Department of Pharmacology and Therapeutics in collaboration with Rajshahi Diabetic Association General Hospital, Rajshahi, for one year from January 2021 to December 2021 on 50 uncontrolled T2DM patients (glycosylated hemoglobin, HbA1c > 7.0 to ≤ 10.5%) for more than 12 weeks. The investigating drug, empagliflozin 10 mg (1 tablet) as a once-daily dose, was added to the ongoing treatment of each patient as 3rd line treatment and was followed up at 6 and 12 weeks. Results: The mean FBS at baseline was 10.8 mmol/L, which declined to 8.5 mmol/L at six weeks and then to 7.2 mmol/L after 12 weeks of intervention with Empagliflozin as add-on therapy in patients with uncontrolled T2DM. The overall reduction of FBS from baseline to 12 weeks of intervention was statistically significant (p < 0.001). Simultaneously the mean HbA1c also reduced from 9.4% to 7.7% after six weeks and to 7.1% after 12 weeks of intervention (p < 0.001). The mean systolic and diastolic blood pressures decreased from 129 mmHg to below 120 mmHg (p < 0.001) and 82.3 mmHg to below 80 mmHg (p = 0.029), respectively, after three months of intervention. Conclusion: Empagliflozin as add-on therapy responded well in patients with uncontrolled T2DM (previously treated with metformin combined with either sulfonylurea or DPP-4 inhibitors and/or supplemented by insulin) in achieving glycemic control.  TAJ 2022; 36: No-1: 89-95
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恩格列净辅助治疗未控制的2型糖尿病患者的疗效
背景:二甲双胍被推荐作为不能通过改变生活方式控制血糖的2型糖尿病(T2DM)患者的一线药物治疗。二甲双胍最初可降低血糖,但随着糖尿病的进展,单用二甲双胍往往无法维持血糖控制,需要额外的治疗。恩格列净是一种有效的选择性钠-葡萄糖共转运蛋白2 (SGLT2)抑制剂,可有效降低血糖水平,作为单一疗法或现有疗法的附加疗法,可显著改善血糖控制和体重。材料与方法:该准实验研究于2021年1月至2021年12月在Rajshahi糖尿病协会总医院的药理学和治疗学系合作进行,为期一年,对50例未控制的T2DM患者(糖化血红蛋白,HbA1c > 7.0至≤10.5%)进行为期12周以上的研究。研究药物恩帕列净10mg(1片)作为每日一次的剂量,被添加到每名患者正在进行的治疗中作为三线治疗,并在6周和12周进行随访。结果:基线时的平均FBS为10.8 mmol/L, 6周时降至8.5 mmol/L,在恩帕列净辅助治疗12周后降至7.2 mmol/L。从基线到干预12周,FBS的总体降低具有统计学意义(p < 0.001)。同时,干预6周后平均HbA1c也从9.4%降至7.7%,干预12周后降至7.1% (p < 0.001)。干预3个月后,平均收缩压和舒张压分别从129 mmHg降至120 mmHg以下(p < 0.001)和82.3 mmHg降至80 mmHg以下(p = 0.029)。结论:恩格列清作为附加治疗对未控制的T2DM患者(先前使用二甲双胍联合磺脲类或DPP-4抑制剂治疗和/或补充胰岛素治疗)达到血糖控制效果良好。泰姬酒店2022;36: no - 1:9 9-95
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