IDF21-0513 Real world assessment of effectiveness and safety of FDC of remogliflozin etabonate and Vildagliptin in T2DM patients

Bhattacharyya, S.; Katare, Sagar; Khaladkar, Kiran

doi:10.1016/j.diabres.2022.109562

Cited by 2 publications

(5 citation statements)

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“…A study similar to our design was conducted by Bhattacharyya et al, which included 50 patients. 10 There was a statistically significant reduction in FBS, PPBS, and HbA1c after three months of treatment; the mean change of HbA1c at the third month from baseline was −1.9% ( P < 0.0001) similar to the present study. They noted a significant reduction in the mean FBS value from baseline by 38 mg/dl ( P < 0.0001); however, a non-significant reduction in FBS by 32.5 mg/dl ( P = 0.211) was noted in the present study.…”

Section: Discussionsupporting

confidence: 88%

“…A significant reduction in SBP (−3.5 mmHg, P = 0.03) was also noted in the study conducted by Bhattacharyya et al, but not for DBP and total body weight. 10 The present study is significant as it is the first of its kind that assessed the efficacy of the FDC of remogliflozin 100 mg + vildagliptin 50 mg. To the best of our knowledge, we could not find any other research articles on this fixed drug combination although we found a very few paper presentations in conferences.…”

Section: Discussionmentioning

confidence: 99%

“…The mean age of the study population noted in our study was similar to the one observed by Bhattacharyya et al, which was 54.8 ± 11.5 years. 10 A phase III study conducted by Khaladkar et al compared the efficacy and safety of this fixed drug combination remogliflozin 100 mg + vildagliptin 50 mg (RV) added to metformin, with empagliflozin 25 mg + linagliptin 5 mg (EL). 11 It showed a significant reduction in the FBS, PPBS, and HbA1c in both the treatment arms and concluded that RV is non-inferior to EL.…”

Section: Discussionmentioning

confidence: 99%

“…A significant reduction in SBP (−3.5 mmHg, P = 0.03) was also noted in the study conducted by Bhattacharyya et al, but not for DBP and total body weight. 10…”

Section: Discussionmentioning

confidence: 99%

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Use of Fixed-dose Combination Therapy with Remogliflozin and Vildagliptin as an Add-on Drug in Improving the Glycemic Control of Type 2 Diabetes Mellitus: An Observational Study

Petchiappan

Mathew

Jose

et al. 2023

Journal of Pharmacology and Pharmacotherapeutics

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Objective To evaluate whether a fixed dose combination (FDC) with remogliflozin and vildagliptin as an add-on therapy can improve the glycemic control in the management of type 2 diabetes mellitus and also the non-glycemic effects on physical profile, blood pressure, lipids, and insulin resistance. Materials and Methods An observational study that included 50 poorly controlled diabetics from April 2021 to September 2021. Patients were divided into two groups – those who were prescribed this FDC by their treating physician as an add-on drug were formed as group 1 ( n = 28). Comparison group was age-matched patients who received other standard anti-diabetic medications, categorized as group 2 ( n = 22). Fasting and postprandial sugars were done at baseline, the third and sixth month; glycated hemoglobin, body mass index, blood pressure, and lipids were done at baseline and the sixth month. Changes in blood sugar levels and glycated hemoglobin (HbA1C) at the third and sixth month from the baseline were compared using the Mann-Whitney U test. P-value less than 5% was considered statistically significant. Results A statistically significant reduction in mean HbA1c was noted in group 1 [–1.80 (−3.20, −0.15)] when compared to group 2 [0.50 (0.05, 0.80)] at the end of the third month. At the end of the sixth month, a significant reduction in the HbA1c level was noted in group 1 [(7.83 ± 0.87 %) when compared to baseline (10.3 ± 1.75%)]. Change in PPBS value at the third month from baseline was also statistically significant between groups 1 and 2 (−62.0 mg%, 19.0, P = 0.003). With respect to the body mass index and blood pressure, we did not find any significant difference. Conclusion The fixed drug combination improves glycemic control by significantly reducing mean HbA1c at the third and sixth month from baseline and there was no significant effect on body mass index, blood pressure, and lipids.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…A significant reduction in SBP (−3.5 mmHg, P = 0.03) was also noted in the study conducted by Bhattacharyya et al, but not for DBP and total body weight. 10…”

Section: Discussionmentioning

confidence: 99%

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Use of Fixed-dose Combination Therapy with Remogliflozin and Vildagliptin as an Add-on Drug in Improving the Glycemic Control of Type 2 Diabetes Mellitus: An Observational Study

Petchiappan

Mathew

Jose

et al. 2023

Journal of Pharmacology and Pharmacotherapeutics

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“…There were no significant changes in HbA1c found in our study when patients were switched to Remogliflozin etabonate. Bhattacharyya S, et al (2022) reported statistically significant reduction from baseline, observed in HbA1c (-1.9%, p<0.0001) after initiation of the treatment with Remogliflozin etabonate [17]. However, Agrawal P, et al (2022) found that HbA1c levels increased marginally but significantly in the patients after switching to Remogliflozin from Empagliflozin, Canagliflozin or Dapagliflozin [18].…”

Section: Mahapatra H Et Al (2022) Illustrated the Experience Ofmentioning

confidence: 95%

Variation in Glycemic and Extra Glycemic Parameters with Initiation of Remogliflozin Etabonate in Patients of T2DM Having a Good Glycemic Control with other SGLT2 Inhibitors

2022

J Diabetes Treat

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Introduction:Remogliflozin etabonate is the latest addition to the Sodium glucose co-transporter-2 (SGLT2) inhibitor class of drugs which is a potent and selective inhibitor of SGLT2. A real world non-randomized, single centre, retrospective study was done to assess changes in glycemic and extra glycemic parameters of type 2 diabetes mellitus (T2DM) patients who were well controlled (HbA1c ≤ 7%) with other SGLT2 inhibitors (Dapagliflozin and Empagliflozin), but had difficulty to afford the high cost of therapy from out of pocket expenditure and voluntarily requested for a switchover for economic reasons. Materials and methods:Retrospective observation of the variations in glycemic and extra glycemic parameters including blood pressure, body weight, lipid profile and eGFR of 32 patients was recorded, when they were initiated on Remogliflozin etabonate, replacing other SGLT2 inhibitors (19 were on Empagliflozin and 13 were on Dapagliflozin). The data was tabulated for a total of three visits (First -initial, Second -at three months from initial and Third-at six months from initial), after which analysis was done.Results: There were no significant changes in HbA1c value from baseline after initiation of remogliflozin etabonate from dapagliflozin and empagliflozin. There was also no significant reduction of blood pressure, body weight and eGFR from baseline for patients switched from Dapagliflozin. However, the change in blood pressure and body weight was statistically significant for patients switched from Empagliflozin (p<0.01). Conclusion:Remogliflozin etabonate given as 100 mg twice daily is non-inferior to Empagliflozin 10 mg / Dapagliflozin 10 mg given as once daily to patients of T2DM as far as their glycemic goals are concerned with favourable extra glycemic benefit and cost burden reduction of more than 50%.

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IDF21-0513 Real world assessment of effectiveness and safety of FDC of remogliflozin etabonate and Vildagliptin in T2DM patients

Cited by 2 publications

References 0 publications

Use of Fixed-dose Combination Therapy with Remogliflozin and Vildagliptin as an Add-on Drug in Improving the Glycemic Control of Type 2 Diabetes Mellitus: An Observational Study

Use of Fixed-dose Combination Therapy with Remogliflozin and Vildagliptin as an Add-on Drug in Improving the Glycemic Control of Type 2 Diabetes Mellitus: An Observational Study

Variation in Glycemic and Extra Glycemic Parameters with Initiation of Remogliflozin Etabonate in Patients of T2DM Having a Good Glycemic Control with other SGLT2 Inhibitors

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