Fixed-dose combination in management of type 2 diabetes mellitus: Expert opinion from an international panel

Kalra, Sanjay; Ak, Das; Priya, Gagan; Ghosh, Sujoy; Mehrotra, RN; Das, Sambit; Bajaj, Sarita; Deshmukh, Vaishali; Sanyal, Debmalya; Chandrasekaran, S.; Khandelwal, Deepak; Joshi, Ameya; Nair, Tiny; Eliana, Fatimah; Permana, Hikmat; Fariduddin, .; Shrestha, P.; Shrestha, Dina; Kahandawa, S; Sumanathilaka, Manilka; Shaheed, A; Rahim, AA; Orabi, Abbas; Alani, A.; Hussein, Wijdan Akram; Kumar, Dileep; Shaikh, Khalid

doi:10.4103/jfmpc.jfmpc_843_20

Cited by 30 publications

(22 citation statements)

References 17 publications

(11 reference statements)

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“…This evidence will aid the treating clinicians in decision making to provide the individualized and holistic care to the patients for better diabetes management. According to a recent Indian expert’s panel opinion, 15 a more proactive, early, and aggressive approach has been recommended to be followed with early introduction of the intervention for diabetes. It was recommended that early combination therapy provides a good legacy effect and therefore, helps in improving glycemic profiles without significantly increasing the incidence of side effects.…”

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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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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“…FDC drugs combine multiple active ingredients in a single dose product providing synergistic effects, better clinical outcomes, tolerability, and cost-effectiveness, which increases compliance and treatment adherence in patients. [10,16] Combining SGLT2i with DPP4i have shown to simplify the anti-diabetic therapy and improve the drug compliance. [7] In the present study, we assessed the efficacy and safety of remogliflozin etabonate (100 mg) and teneligliptin (10 mg) twice-daily FDC therapy versus teneligliptin (20 mg) in patients with uncontrolled T2D on background therapy of metformin.…”

Section: Discussionmentioning

confidence: 99%

“…Expert opinion from International panel of clinicians on clinical approach to FDCs in the management of T2DM recommended a rational use of FDCs (double or triple) in managing such patients in India. [10] The panel aligned that adding a lowdose antidiabetic medication to monotherapy can enhance drug efficiency by 80%. Likewise, with the complementary mode of action, both DPP4i and SGLT2i have proven to be an adequate dual combination therapy to achieve target HbA1c levels in patients with inadequately controlled diabetes on high-dose metformin therapy.…”

Section: Introductionmentioning

confidence: 99%

A Randomized, Double-blind, Active-controlled Study of Remogliflozin Etabonate 100 mg plus Teneligliptin 10 mg Twice-daily versus Teneligliptin 20 mg Oncedaily as add-on to Metformin Monotherapy in Indian Diabetic Patients

2022

J Diabetes Treat

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Background: Fixed-dose combination (FDC) of sodium-glucose co-transporter-2 inhibitor (SGLT2i) and dipeptidyl peptidase-4 inhibitor (DPP4i) is a promising approach for type 2 diabetes (T2D) management due to their complementary mode of action. The present study evaluated efficacy and safety of FDC of remogliflozin etabonate (RE) and teneligliptin as add-on to metformin monotherapy in uncontrolled T2D patients compared to standard teneligliptin therapy. Methods: This 16-week, double-blind, double-dummy, active-controlled, parallel-group, multicentric study randomized 308 patients (glycated hemoglobin levels [HbA1c] 8-11%) who were on background metformin therapy (≥1500 mg/day) to receive add-on treatment of either RE 100 mg plus teneligliptin 10 mg twice-daily (RE+TE10) or teneligliptin 20 mg (TE20) once-daily. The primary endpoint was mean change in HbA1c from baseline to Week 16. Secondary endpoints were changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and body weight from baseline to Week 16. Safety endpoints were assessed throughout the study. Results: At Week 16, significant reduction in HbA1c, FPG, PPG and body weight were noted in both the groups. The mean change in HbA1c from baseline to Week 16 was superior in the RE+TE10 (-1.23%) versus TE20 (-0.79%), whereas the mean change in FPG, PPG, body weight along with incidence of treatment-emergent adverse events (RE+T10: 11.8% vs. T20: 14.2%) were comparable between the two groups. Conclusion: FDC of remogliflozin/teneligliptin was superior to teneligliptin as an add-on to metformin in HbA1c reduction from baseline to Week 16 in Indian patients with uncontrolled T2DM on metformin therapy and was well-tolerated.

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“…To eliminate inter-individual variance, it is usual to equalize the dosage of anticancer medications depending on Body Surface Area (BSA) and the patient's height and weight. Given the benefits and drawbacks of both constant and variable dosing, fixed dosing looks to be the best option, especially in light of the expenses involved [30][31][32].…”

Section: Objective 3: To Propose An Effective Dosing Approach Based O...mentioning

confidence: 99%

Variable vs. Fixed Dosing of Monoclonal Antibodies in Oncology

Tzenios¹,

Tazanios²,

Chahine³

2022

Preprint

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Oncological patients need the proper doses of medications to facilitate their recovery. The two basic approaches used in dosing Monoclonal Antibodies (mAbs) are fixed-dose combination and variable dosing. In Fixed-Dose Combination Drugs (FDCs), two or more active components are combined in a single formulation at a predetermined dose. Variable dosage, which has long been the industry standard, is the polar opposite of this approach. The body changes over time; the Body Surface Area (BSA) in square meters is often used as a Measure (m2). This study uses a systematic review. Most mAbs used in oncology are predominantly given as cytotoxic anticancer drugs using body-size-based (variable) regimens. Despite the benefits of fixed-dose, variable dosing has become the industry standard, despite being criticized for ineffectiveness. While variable dosing has some advantages, the prevalent view is that continuous dosing has significant advantages based on the balance of probabilities. After assessing each alternative, including its benefits and drawbacks, history of use, and suitability in the current context, fixed dosing emerges as a viable option.

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Fixed-dose combination in management of type 2 diabetes mellitus: Expert opinion from an international panel

Cited by 30 publications

References 17 publications

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

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

A Randomized, Double-blind, Active-controlled Study of Remogliflozin Etabonate 100 mg plus Teneligliptin 10 mg Twice-daily versus Teneligliptin 20 mg Oncedaily as add-on to Metformin Monotherapy in Indian Diabetic Patients

Variable vs. Fixed Dosing of Monoclonal Antibodies in Oncology

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