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This retrospective study examined the real-world effectiveness and safety of the fixed-dose combination (FDC) of vildagliptin sustained-release (SR) and metformin SR among type 2 diabetes mellitus (T2DM) sufferers across various centers in India.
Fixed-dose combination of vildagliptin SR and metformin SR markedly improves HbA1c, fasting, and postprandial glucose levels in patients with type 2 diabetes mellitus, with a favorable safety and tolerability profile.
This retrospective study examined the real-world effectiveness and safety of the fixed-dose combination (FDC) of vildagliptin sustained-release (SR) and metformin SR among type 2 diabetes mellitus (T2DM) sufferers across various centers in India.
In this post-marketing study, data from adult T2DM patients treated at 95 centers across India were analyzed. The study population encompassed patients (aged 18 to 65 years), either newly diagnosed or with suboptimal glycemic control on their existing antidiabetic regimen, who were given vildagliptin SR 100 mg + metformin SR 500 or 1000 mg at their physician’s discretion. The primary efficacy parameters were changes in glycated hemoglobin (HbA1c;%), postprandial plasma glucose (PPG), and fasting plasma glucose (FPG) levels from baseline to 90 days.
A total of 1,090 patients were incorporated. The average age was 54.46 years, with a mean baseline HbA1c of 8.19 ± 1.22%. Of these, 89.26% received the FDC of vildagliptin 100 mg SR with metformin 500 mg SR, while 10.73% were given the FDC with metformin 1000 mg SR. At the end of 90 days, the overall cohort illustrated a prominent reduction in HbA1c, FPG, and PPG (Table 1):
No serious adverse effects were reported during the study period.
In the real-world clinical setting, the FDC of vildagliptin SR and metformin SR proved to be a safe, effective, and well-tolerated option for glycemic control in T2DM sufferers, including those newly diagnosed and those not adequately controlled on previous therapies.
Cureus
Efficacy and Safety of Vildagliptin Sustained-Release and Metformin Sustained-Release Fixed-Dose Combination in Indian Patients With Type 2 Diabetes Mellitus: A Real-World Perspective
Archana Sarda et al.
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