Empagliflozin/metformin fixed-dose combination: a review in patients with type 2 diabetes

Abstract

Most patients with type 2 diabetes, who receive monotherapy, are unable to maintain glucose levels with the progress of disease. Therefore, combination therapy with two or more anti-diabetic agents of different classes is highly desired. Sodium glucose co-transporter 2 (SGLT2) inhibitors improve glycemic control through increasing urinary glucose excretion, which is independent of β-cell function. In addition, they are generally well tolerated and associated with a low risk of hypoglycaemia. SGLT2 inhibitors as add-on therapy to metformin have an additive effect on glycemic control in patients with type 2 diabetes, and fixed-dose tablet is likely to reduce pill burden and then improve patients' adherence. Areas covered: This article reviews empagliflozin/metformin combination therapy for the treatment of type 2 diabetes. The clinical efficacy and tolerability of empagliflozin/metformin in patients with type 2 diabetes are discussed based on the available literature. Expert opinion: It was found that empagliflozin/metformin combination therapy could significantly improve glycemic control, body weight and blood pressure with a low risk of hypoglycaemia. In addition, the empagliflozin/metformin fixed-dose tablets, supported by bioequivalence studies, could reduce pill burden to further achieve the improved patients' adherence, better glycemic control and optimized cost-effectiveness.

Fixed dose drug combinations – are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries

“…FDCs include those with a sulfonyl urea (SU) and metformin, metformin and acarbose, DPP-4 (dipeptidyl peptidase-4) inhibitors and metformin, thiazolidinedione and metformin, alogliptin and pioglitazone, sodium-glucose transport protein 2 (SGLT2) inhibitors and metformin, and a SGLT2 inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor [210,[218][219][220]. FDCs containing metformin and a DPP-4 inhibitor, as well as metformin and SGLT2 inhibitors are seen in particular as providing metformin with complementary mechanisms of action to improve glycemic control whilst reducing the pill burden, and similarly with saxagliptin/dapagliflozin FDCs [218,[221][222][223][224].…”

The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany

“…The combination of metformin and empagliflozin has been shown to improve glycemic control compared with either agent alone, with a low risk of hypoglycemia. [12][13][14] It has also been shown to be superior to the combination of metformin and glimepiride in HbA1c change from baseline in a 2-year study, while reducing non-severe hypoglycemia by more than 20% (>90% relative risk reduction). 15 A switch analysis of previous glucose-lowering treatment showed that empagliflozin was generally not introduced as a replacement for other drugs but was usually added to the antidiabetic regimen.…”

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“…Erosion Model: This equation defines the drug release based on erosion alone. 3 Where, "Q" is fraction of drug released at time t and "k 3 " is release rate constant.…”

“…Combination therapy with these two drugs has the potential to offer improved glucose control compared with that achieved with the individual agents. This approach can reduce the dosing frequency for patients, leading to a simplified dosing regimen, which may assist adherence to therapy 1,2,3 .…”