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Combination of Empagliflozin and Metformin Therapy: A Consideration of its Place in Type 2 Diabetes Therapy.

ABSTRACT: Type 2 diabetes mellitus (T2DM) is characterized by multiple metabolic abnormalities and current approaches to treatment involve a stepwise approach, frequently involving the use of combination therapy. The addition of the sodium-glucose cotransporter-2 (SGLT2) inhibitor, empagliflozin, to metformin therapy has been shown to be effective and well tolerated in patients with T2DM and is 1 of the several recommended treatment options. The publication of the EMPA-REG OUTCOME study, which showed that empagliflozin is associated with cardiovascular (CV) and renal benefits, has resulted in changes in treatment guidelines for T2DM. Because many patients with T2DM will require treatment with more than 1 glucose-lowering agent, consideration of the role of empagliflozin in combination therapy is relevant. The clinical data reviewed show that the combination of empagliflozin/metformin offers the potential to improve glycemic control in T2DM and reduces body weight and blood pressure, vs each agent individually, with a manageable risk profile. This combination could be suitable for patients with T2DM who are inadequately controlled by metformin, in particular, for patients who would benefit from modest reductions in blood pressure and body weight or who have risk factors for CV disease or declining renal function. Empagliflozin/metformin is also available as a single-pill combination, which has the potential to provide a simplified treatment regimen and could lead to improved clinical outcomes compared with coadministration of individual tablets.

SUBMITTER: Goldman JD

PROVIDER: S-EPMC6043932 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Combination of Empagliflozin and Metformin Therapy: A Consideration of its Place in Type 2 Diabetes Therapy.

Goldman Jennifer D JD

Clinical medicine insights. Endocrinology and diabetes 20180710

Type 2 diabetes mellitus (T2DM) is characterized by multiple metabolic abnormalities and current approaches to treatment involve a stepwise approach, frequently involving the use of combination therapy. The addition of the sodium-glucose cotransporter-2 (SGLT2) inhibitor, empagliflozin, to metformin therapy has been shown to be effective and well tolerated in patients with T2DM and is 1 of the several recommended treatment options. The publication of the EMPA-REG OUTCOME study, which showed that ...[more]

PMID: 30013414

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Project description:OBJECTIVE:To update clinicians with an overview of empagliflozin for the treatment of type 2 diabetes mellitus (T2DM), with focus on use in combination regimens. METHODS:Keyword searches were conducted in the Medline database to identify literature reporting clinical trials of at least 12 weeks' duration using empagliflozin treatment in patients with T2DM. RESULTS:When given as monotherapy or in combination therapy (as add-on or single-pill therapy) with metformin, pioglitazone, sulfonylurea, linagliptin, and insulin, empagliflozin produced clinically meaningful reductions in glycated hemoglobin levels, plasma glucose concentrations, bodyweight, and blood pressure. These changes were sustained during long-term treatment. In a dedicated cardiovascular event trial, empagliflozin on top of standard of care demonstrated a significant reduction in the risk of cardiovascular mortality and all-cause mortality. Across the clinical trials, empagliflozin combination therapies were well tolerated, and empagliflozin used alone was not associated with increased risk of hypoglycemia versus placebo. Indeed, the combination of empagliflozin and metformin had a significantly reduced rate of hypoglycemia compared with the combination of metformin and a sulfonylurea. On the other hand, empagliflozin treatment did have increased risk of genital infections compared with placebo. In clinical trials to date, diabetic ketoacidosis was not seen more frequently with empagliflozin than with placebo, but physicians should be alert to the possibility of this rare event. CONCLUSION:Empagliflozin has the potential to make an important contribution to the treatment of patients with T2DM. In some patients, empagliflozin may be used as monotherapy, but it is most likely to be used in combination with other therapies. Given the reduced risk of mortality seen when empagliflozin was added to standard care in patients at high cardiovascular risk, as well as the lack of alternative options for patients at lower cardiovascular risk, empagliflozin may be added to ongoing regimens for a significant proportion of patients.

Project description:BACKGROUND:Deteriorated arterial function and high incidence of cardiovascular events characterise diabetes mellitus. Metformin and recent antidiabetic drugs, SGLT2 inhibitors, reduce cardiovascular events. We explored the possible effects of empagliflozin's effect on top of metformin treatment on endothelial function and arterial stiffness parameters in type 1 diabetes mellitus (T1DM) patients. METHODS:Forty T1DM patients were randomised into three treatment groups: (1) empagliflozin (25 mg daily), (2) metformin (2000 mg daily) and (3) empagliflozin/metformin (25 mg daily and 2000 mg daily, respectively). The fourth group received placebo. Arterial function was assessed at inclusion and after 12 weeks treatment by: endothelial function [brachial artery flow-mediated dilation (FMD), reactive hyperaemia index (RHI)], arterial stiffness [pulse wave velocity (PWV) and common carotid artery stiffness (?-stiffness)]. For statistical analysis one-way analysis of variance with Bonferroni post-test was used. RESULTS:Empagliflozin on top of metformin treatment significantly improved endothelial function as did metformin after 12 weeks of treatment: FMD [2.6-fold (P?<?0.001) vs. 1.8-fold (P?<?0.05)] and RHI [1.4-fold (P?<?0.01) vs. 1.3-fold (P?<?0.05)]. Empagliflozin on top of metformin treatment was superior to metformin in improving arterial stiffness parameters; it significantly improved PWV and ?-stiffness compared to metformin [by 15.8% (P?<?0.01) and by 36.6% (P?<?0.05), respectively]. Metformin alone did not influence arterial stiffness. CONCLUSION:Empagliflozin on top of metformin treatment significantly improved arterial stiffness compared to metformin in T1DM patients. Endothelial function was similarly improved in all treatment groups. Empagliflozin seems to possess a specific capacity to decrease arterial stiffness, which could support its cardioprotective effects observed in large clinical studies. Trial registration Clinical trial registration: NCT03639545.

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Combination of Empagliflozin and Metformin Therapy: A Consideration of its Place in Type 2 Diabetes Therapy.

Publications

Combination of Empagliflozin and Metformin Therapy: A Consideration of its Place in Type 2 Diabetes Therapy.

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