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The fixed-dose combination of vildagliptin and metformin markedly improves glycemic control with no serious adverse events in T2DM people, including those newly diagnosed or poorly controlled on existing therapy.
A multicenter post-marketing study portrayed the real-world effectiveness, safety, and tolerability of a fixed-dose combination (FDC) of vildagliptin sustained-release (SR) and metformin SR in patients with type 2 diabetes mellitus (T2DM). The study focused on patients who were either newly diagnosed or inadequately controlled on existing therapies, offering valuable insights into the role of this combination in routine clinical practice.
The study analyzed retrospective data from 1,090 adult T2DM patients (aged 18 to 65 years) who received the vildagliptin SR and metformin SR FDC based on the discretion of their treating physician. These patients were recruited from 95 centers across India. The majority of patients (89.26%) were prescribed the FDC containing vildagliptin 100 mg SR and metformin 500 mg SR, while 10.73% received the formulation with 1000 mg SR of metformin.
Results showed a considerable reduction in glycemic parameters over a 90-day period. The mean baseline glycated hemoglobin (HbA1c) was 8.19% ± 1.22. In addition to HbA1c improvement, patients experienced a substantial drop in fasting plasma glucose and postprandial plasma glucose, both with p-values less than 0.0001, indicating high statistical significance, as shown in Table 1:
Importantly, the FDC was well-tolerated, with no serious adverse events reported during the study. This highlights the favorable safety profile of the combination, making it a reliable choice for glycemic control. In conclusion, this large-scale real-world study confirms that the FDC of vildagliptin SR and metformin SR is both effective and safe for improving glycemic control in T2DM sufferers. Its use in newly diagnosed patients as well as those inadequately controlled on prior therapies supports its clinical utility and potential for widespread adoption in day-to-day diabetes care.
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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