Diabetes, metabolic syndrome and obesity : targets and therapy · 2025
Exploring the Real-World Effectiveness of Empagliflozin and Linagliptin Fixed-Dose Combination in Type 2 Diabetes Patients of Bangladesh: A Prospective Multi-Center Observational Study.
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Sharifuzzaman Mirza, Paul Ajit Kumar, Akteruzzaman Md, Bhuiyan S N Haider, Haider Rezaul, Sharker Shoma, Sultana Dahlia, Alam Khondoker Monirul, Abu Zafar Sikandar, Kashem Md Abul, Abu Zahid Md, Islam A F M Nazmul, Abedin Md Zainal, Anar Fouzia, Hasan Md Farucul, Selim Shahjada, Islam Sunjida, Ahammed Afsar, Hosen Mobarak, Qureshi Nazmul Kabir, Hossain Mohammad Afjal, Begum Aysha, Afrooz Farhana, Kobir A S M Musa, Akter Farhana, Mustafa Sadia Jabeen, Rahman Md Motiur, Saifuddin M
Аннотация
PURPOSE: The fixed-dose combination (FDC) of empagliflozin and linagliptin is a promising treatment for type 2 diabetes mellitus (T2DM), but real-world data from Bangladesh is limited. This study aimed to assess the effectiveness and safety of empagliflozin 10 mg/linagliptin 5 mg [Empa/Lina (10/5)] FDC among T2DM patients at real-world settings in Bangladesh.
PATIENTS AND METHODS: This prospective, multicenter, observational study enrolled 822 adults with T2DM across Bangladesh. Patients receiving Empa/Lina (10/5) FDC either alone or with other antidiabetic medications at practice were enrolled. Glycemic control, body mass index (BMI), blood pressure, and adverse events were assessed over three months.
RESULTS: Mean HbA1c decreased significantly from baseline to three months in both the Empa/Lina (10/5) FDC alone group (9.13% to 8.18%, p<0.001) and the FDC plus other antidiabetics group (10.20% to 8.12%, p<0.001). Fasting and post-prandial blood glucose levels also improved significantly (p<0.001). BMI decreased from 26.81 kg/m2 to 25.90 kg/m2 (p=0.008). Systolic and diastolic blood pressure reduced by 11.09 mmHg and 4.41 mmHg, respectively (p<0.001). The estimated glomerular filtration rate remained stable. Improvements were consistent across patient subgroups with various comorbidities. Adverse events were infrequent, with hypoglycemia (10.95%), genital mycotic infection (3.04%), and urinary tract infections (2.80%) being the most common.
CONCLUSION: Empa/Lina (10/5) FDC demonstrated significant improvements in glycemic control, BMI, and blood pressure with a favorable safety profile in Bangladeshi patients with T2DM. These real-world findings support its use as an effective treatment option in this population.
PATIENTS AND METHODS: This prospective, multicenter, observational study enrolled 822 adults with T2DM across Bangladesh. Patients receiving Empa/Lina (10/5) FDC either alone or with other antidiabetic medications at practice were enrolled. Glycemic control, body mass index (BMI), blood pressure, and adverse events were assessed over three months.
RESULTS: Mean HbA1c decreased significantly from baseline to three months in both the Empa/Lina (10/5) FDC alone group (9.13% to 8.18%, p<0.001) and the FDC plus other antidiabetics group (10.20% to 8.12%, p<0.001). Fasting and post-prandial blood glucose levels also improved significantly (p<0.001). BMI decreased from 26.81 kg/m2 to 25.90 kg/m2 (p=0.008). Systolic and diastolic blood pressure reduced by 11.09 mmHg and 4.41 mmHg, respectively (p<0.001). The estimated glomerular filtration rate remained stable. Improvements were consistent across patient subgroups with various comorbidities. Adverse events were infrequent, with hypoglycemia (10.95%), genital mycotic infection (3.04%), and urinary tract infections (2.80%) being the most common.
CONCLUSION: Empa/Lina (10/5) FDC demonstrated significant improvements in glycemic control, BMI, and blood pressure with a favorable safety profile in Bangladeshi patients with T2DM. These real-world findings support its use as an effective treatment option in this population.