New fixed dose chemical combinations: the way forward for better diabetes type II management?

Abdulsalim, Suhaj; Vayalil, Munawar Peringadi; Miraj, Sonal Sekhar

doi:10.1080/14656566.2016.1241235

“…Similarly, Raskin et al [36] demonstrated the ability of coupling repaglinide/metformin as an FDC regimen to induce a more rapid decrease in HbA1c levels, as opposed to monotherapy. The present findings are in support of such clinical studies which claim that lower doses of 2 agents in fixed combinations may offer greater efficacy in combination, at the same time reducing the risk of adverse events that may occur with higher doses of monotherapy [37].…”

Section: Fdc As a Measure To Improve Glycaemic Index In T2dm Patientssupporting

confidence: 87%

The Need for Fixed Dose Combination (FDC) for the Management of Type 2 Diabetes in Mauritius

2019

Endocrinol Diabetes Metab J

0

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The State health services of Mauritius are provided free to all 1.27 million inhabitants of the island. Despite so, successive surveys by the Ministry of Health and Quality of Life have shown that diabetes remains a major public health threat to Mauritians. With 24% of the adult population affected by (type 2 diabetes) T2D, our island is ranked amongst those countries with highest diabetes-related mortality, which emphasizes the need for educating the population proper self-management of the disease. It is also evident that poor treatment adherence looms large. Patients with T2D under conventional treatment often require multiple medications to achieve glycaemic control. This induces a significant pill burden when coupled with co-morbid conditions associated to diabetes and deters adherence to treatment. Public health institutions in Mauritius support the usage of loose pills for diabetes treatment as opposed to private institutions who promote the adoption of Fixed Dose Combination (FDC) therapy as a means to improve treatment efficacy. A scaled-study was conducted to explore the efficiency and patients' perspectives on FDC in the management of T2D. 65 patients from the Diabetes and Vascular Health Centre were grouped according to their treatment regimen: FDC from start; switched to FDC from loose pills; reverted to loose pills after trying FDC and loose pills treatment. Patients were interviewed and their clinical parameters recorded. Results showed that 67.7 % of patients were taking more than 7 pills a day to achieve glycaemic control, with only 30.8 % being made aware of possible FDC options by their healthcare practitioner. 96.3% patients who were on loose pills expressed their willingness to shift to FDC if made available in public institutions. Overall glycaemic control was better managed among the FDC group. Our findings concluded that the loose pill regime was indeed problematic for diabetics to achieve optimal glycaemic control. FDC could be pivotal in improving their health outcomes, barriers such as communication of treatment availabilities, financial constraints, shared decision-making and self-management training also need to be addressed.

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“…FDCs are increasingly used in clinical practice for a range of chronic disorders that require the use of multiple treatments, such as chronic obstructive pulmonary disease [22], hypertension [23,24], hepatitis C [25,26], and HIV infection [27,28], with the aim of simplifying treatment regimens and improving clinical outcomes. Similarly, in the field of T2D management, the use of FDCs of effective and well-tolerated therapies can offer a useful treatment option to help optimize therapy for individual patients, and several FDC therapies for T2D are available for clinical use [29].…”

Section: Introductionmentioning

confidence: 99%

Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes

Lingvay

¹

,

Beetz

²

,

Sennewald

³

et al. 2020

Postgraduate Medicine

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Objectives: Fixed-dose combination (FDC) therapy can improve outcomes in type 2 diabetes (T2D). We evaluated the bioequivalence of 2 doses of an FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor, versus corresponding free tablet combinations. Methods: Two randomized, open-label, two-way crossover studies in healthy adults compared: 2 FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR 1000 mg (Study 1; N = 30), 1 FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR 1000 mg (Study 2; N = 30) versus corresponding dose of free combinations. Subjects received study medication under fed conditions; washout was ≥35 days between treatments. Primary endpoints: area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72 hours for linagliptin, and peak plasma concentration (C max) for empagliflozin, linagliptin, and metformin. Bioequivalence was defined as adjusted geometric mean ratios (FDC: free combination) and two-sided 90% confidence intervals (CIs) of AUC and C max for each component within 80.00-125.00%. Results: Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively. Study 2: 29/29 treated participants were included in the pharmacokinetic analysis for both periods. The adjusted geometric mean ratios of FDCs to their respective free tablet combinations and two-sided 90% CIs were all within the predefined range. The shapes of the mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR were similar for subjects in the FDC and free combination groups in both studies. No serious adverse events were reported. Conclusion: The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations. Based on these two bioequivalence studies and existing phase 3 data, the FDA has recently approved this triple FDC to improve glycemic control in adults with T2D. PLAIN LANGUAGE SUMMARY: Study supports the convenience of empagliflozin, linagliptin, and metformin XR in 1 tablet as new treatment for type 2 diabetes What is the purpose of this summary? • This summary is to help you understand findings from recent research. • This summary is about 2 studies that are part of a larger group of studies with these medications. Researchers look at many studies to understand whether a medication works, how it works, and whether it is safe to prescribe to patients. What is known? • People with type 2 diabetes often need several medicines to control their blood sugar. • Some people find it difficult to take a lot of different tablets, and some people may not want to. This can lead to difficulties with managing type 2 diabetes. • Combining medicines into 1 tablet may help make it easier to take the treatment and to manage type 2 diabetes, wh...

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Antidiabetic Drugs (A10)

Ritter¹

2018

Ullmann's Encyclopedia of Industrial Chemistry

3

0

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The article contains sections titled: 1. Introduction 2. A10A Insulins and Analogues 3. A10B Blood Glucose‐Lowering Drugs, Excl. Insulins 3.1. A10BA Biguanides 3.2. A10BB Sulfonylureas 3.3. A10BC Sulfonamides (Heterocyclic) 3.4. A10BD Combinations of Oral Blood Glucose‐Lowering Drugs 3.5. A10BF Alpha‐Glucosidase Inhibitors 3.6. A10BG Thiazolidinediones 3.7. A10BH Dipeptidyl Peptidase 4 (DPP‐4) Inhibitors 3.8. A10BJ Glucagon‐Like Peptide‐1 (GLP‐1) Analogues 3.9. A10BK Sodium‐Glucose Cotransporter 2 (SGLT2) Inhibitors 3.10. A10BX Other Blood Glucose‐Lowering Drugs, Excl. Insulins 4. A10X Other Drugs Used in Diabetes

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New fixed dose chemical combinations: the way forward for better diabetes type II management?

Cited by 9 publications

References 42 publications

The Need for Fixed Dose Combination (FDC) for the Management of Type 2 Diabetes in Mauritius

The Need for Fixed Dose Combination (FDC) for the Management of Type 2 Diabetes in Mauritius

Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes

Antidiabetic Drugs (A10)

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