Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia

Chawla, Manoj; Kim, Tae Ho; Mirasol, Roberto; Pathan, Faruque; Cooke, Kathryn; Hours-Zesiger, Peggy; Shete, Abhijit

doi:10.1080/03007995.2018.1476333

Cited by 10 publications

(8 citation statements)

References 21 publications

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“…As the risk of hypoglycemia is more often associated with weight gain, previous studies reported no weight gain with vildagliptin metformin therapy. [ 17 19 20 ] This is confirmed by the present study findings. However, the mean body weight was comparable between both the groups at 6-weeks and 12-weeks follow-up.…”

Section: Discussionsupporting

confidence: 92%

“…The initial combination therapy with vildagliptin and metformin was well tolerated in these patients associated with high HbA1c and cardiovascular risk factors. [ 17 ] This attributed to glucose-dependent nature of vildagliptin with insulinotropic polypeptide-mediated effect that helps to lower the incidence of hypoglycemia. [ 18 ] Moreover, vildagliptin has weight neutral activity.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Safety and Efficacy of Glimepiride-Metformin and Vildagliptin- Metformin Treatment in Newly Diagnosed Type 2 Diabetic Patients

Kumar¹

2021

Indian Journal of Endocrinology and Metabolism

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Objective: To compare the safety and efficacy of glimepiride and vildagliptin as add-on therapy to metformin in newly diagnosed patients with type 2 diabetes mellitus (T2DM). Methods: This 24-week, prospective, comparative, observational study was conducted among newly diagnosed patients with T2DM. The primary endpoint was a change in fasting plasma glucose (FPG), postpradinal glucose (PPG), and HbA1c from the baseline to week 24. The key secondary endpoints were monitoring treatment-emergent adverse events such as hypoglycemia, overall gastrointestinal symptoms and weight gain, and electrocardiogram (ECG) findings. Results: A total of 100 eligible patients were divided into two groups: group A ( n = 50) received vildagliptin plus metformin and group B ( n = 50) received glimepiride plus metformin. The mean age of the patients was 49.98 years and 52.12 years in group A and group B, respectively. Electrocardiographic findings were within normal limits in all the patients from group A, whereas 47 patients from group B showed normal ECG findings. A significant decrease in HbA1c, fasting and post-prandial plasma glucose was observed with group A and group B from the baseline to week-24. However, at week-24, reduction in HbA1c and blood glucose parameters were comparable between the groups. Safety outcomes did not show any events of hypoglycemia with vildagliptin. Mild hypoglycemia was reported with glimepiride in five patients. Conclusion: Vildagliptin-metformin appeared to be equally effective to glimepiride-metformin in reducing HbA1c level and blood glucose parameters, however, resulted in better adverse event profiles with lower risks of hypoglycemia.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Comparison of Safety and Efficacy of Glimepiride-Metformin and Vildagliptin- Metformin Treatment in Newly Diagnosed Type 2 Diabetic Patients

Kumar¹

2021

Indian Journal of Endocrinology and Metabolism

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“… 9 , 10 The INITIAL study and VERIFY trial based studies demonstrated that early combination therapy (vildagliptin plus metformin) provided better glycemic control than initial metformin monotherapy for T2DM patients. 11–14 However, there exist a lacuna of real-world data based evidence wherein the comparative effectiveness of combination therapy and monotherapy has not been assessed in real-world Indian settings. This evidence will aid the treating clinicians in decision making to provide the individualized and holistic care to the patients for better diabetes management.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of a Combination of Metformin and Vildagliptin in Comparison to Metformin Alone in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Evidence Study

Mohan¹,

Zargar²,

Chawla³

et al. 2021

DMSO

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Background Early use of combination therapy in diabetes patients may lead to sustained glycemic control and thereby reduce the progression of diabetic complications. Given the limitation of the traditional stepwise intensification strategy, early combination therapy can be an effective approach. Therefore, this study aims to assess the real-world efficacy of a combination of metformin and vildagliptin in comparison to metformin alone in type 2 diabetes mellitus (T2DM) patients in India. Methods This was an observational, retrospective, non-interventional study based on electronic medical records (EMRs) of 2740 T2DM patients, retrieved from 2010 onwards from 22 diabetes centres across India. Adult drug naïve patients with a 5-year history of T2DM treated with either metformin or a combination of metformin and vildagliptin for at least 3 months were considered for this study. Efficacy assessment was done to evaluate the post-treatment HbA1c levels and patients requiring additional oral antidiabetic drugs (OADs) at the time of follow-up visit. Patients were also analyzed for the occurrence of adverse events. Results Out of the total, 2452 patients were in metformin only arm, and 288 patients were in metformin plus vildagliptin treatment arm. A more significant reduction in HbA1c level was observed in metformin plus vildagliptin arm than metformin only arm (median: −0.5% vs 0%, respectively; p <0.001). Patients requiring additional OAD at follow-up were significantly lesser in the metformin plus vildagliptin arm than the metformin only arm (15.6% vs 35.2%, respectively; p <0.001). The adverse events were comparable across the two arms, and commonly reported adverse events were giddiness, fatigue and gastric discomfort. Conclusion The findings of this EMR-based real-world study emphasizes the need for early initiation of combination therapy (metformin plus vildagliptin) over metformin monotherapy for achieving better glycemic control.

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“…The Initial combiNation therapy with vildagliptin plus metformin In drug-naïve T2DM patients In a reAl Life setting (INITIAL) study demonstrated significant reductions in Hb A1c both at weeks 12 and 24 (−1.6% and −1.9%, respectively; p < 0.001) after initial treatment with vildagliptin–metformin combination in Asian patients with T2DM who presented with high baseline HbA1c (9.3% ± 1.6%) and multiple CV risk factors [ 26 ].…”

Section: Clinical and Real-world Benefits Of The Metformin Sr–vildagl...mentioning

confidence: 99%

Metformin Sustained-Release and Vildagliptin Fixed-Dose Combination for Optimizing Glycemic Control: A Review with Real-World Case Reports

Chawla

Chawla²,

Jethwani³

et al. 2023

Clinics and Practice

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(1) Background: There is a high burden of poor glycemic control in the Indian population with type 2 diabetes mellitus (T2DM). Currently, the use of metformin sustained-release (SR)–vildagliptin fixed-dose combination (FDC) is very low as compared to metformin immediate-release (IR)–vildagliptin FDC which is associated with higher adverse events (AEs). Here, we present real-world effectiveness of metformin SR–vildagliptin FDC treatment in patients with T2DM; (2) Methods: This retrospective analysis was carried out from the medical records of adult T2DM patients visiting a single study center in India (December 2020–February 2021). A total of 10 patients (aged ≥20 years) were treated with vildagliptin 50 mg and metformin SR 500 mg FDC for 15 days. The treatment response was assessed by the percentage of time spent in the target glucose range (TIR at baseline and 15 days after treatment); (3) Results: The glycated hemoglobin (HbA1c) levels at baseline varied between 6.5% to 12%. The glycemic control improved in 70% of patients (mean increase in TIR: 18.9%). Treatment adherence was 100%. No gastrointestinal symptoms or AEs were reported; (4) Conclusions: Early intervention with metformin SR–vildagliptin FDC in patients with T2DM can ensure therapy compliance in terms of superior efficacy along with safety and tolerability. Key summary points: Early initiation of combination therapy helps in early achievement of glycemic goals; Early initiation of metformin and vildagliptin FDC results in significant glycemic control with good tolerability and compliance; Metformin SR–vildagliptin FDC has lower adverse events, compared to metformin IR–vildagliptin FDC; A case series of ten patients with T2DM treated with metformin SR–vildagliptin FDC is presented to assess the real-world effectiveness of this combination.

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Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia

Cited by 10 publications

References 21 publications

Comparison of Safety and Efficacy of Glimepiride-Metformin and Vildagliptin- Metformin Treatment in Newly Diagnosed Type 2 Diabetic Patients

Comparison of Safety and Efficacy of Glimepiride-Metformin and Vildagliptin- Metformin Treatment in Newly Diagnosed Type 2 Diabetic Patients

Efficacy of a Combination of Metformin and Vildagliptin in Comparison to Metformin Alone in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Evidence Study

Metformin Sustained-Release and Vildagliptin Fixed-Dose Combination for Optimizing Glycemic Control: A Review with Real-World Case Reports

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