http://informahealthcare.com/pgm ISSN: 0032-5481 (print), 1941-9260 (electronic) Postgrad Med, 2015; 127(3): 277–281 DOI: 10.1080/00325481.2015.1018798

CLINICAL FEATURE PRACTICE PEARL

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Review of empagliflozin monotherapy for previously untreated patients with type 2 diabetes mellitus: Comparison with sitagliptin Original article: Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC, on behalf of the EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes mellitus: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013;1(3):208–19. Susan Cornell Midwestern University Chicago College of Pharmacy, Downers Grove, IL, USA

Abstract

Keywords

This Practice Pearl provides a review and brief commentary of the 24-week, double-blind, parallel-group, randomized, Phase III study by Roden et al., which assessed the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor empagliflozin, 10 mg or 25 mg as monotherapy, versus placebo and the dipeptidyl peptidase-4 inhibitor sitagliptin, in previously untreated patients with type 2 diabetes mellitus (T2DM). Compared to placebo, empagliflozin improved glycemic control, with additional benefits on bodyweight and systolic blood pressure, versus placebo and sitagliptin. Treatment was well tolerated. The authors concluded that empagliflozin is a potential new approach to treat patients with T2DM who are inadequately controlled with diet and exercise alone. This paper advances our understanding of empagliflozin, which so far, appears to be a promising therapeutic option for the management of patients with T2DM.

Sodium-glucose transporter 2/antagonists and inhibitors, dipeptidyl-peptidase 4 inhibitors, type 2 diabetes mellitus, hypoglycemic agents, empagliflozin, sitagliptin

Practice pearl In their study of previously untreated patients with type 2 diabetes mellitus (T2DM), Roden et al. reported that empagliflozin improves glycemic control compared to placebo, with additional benefits on bodyweight and systolic blood pressure (SBP), compared to placebo and sitagliptin.

History of condition The development of new treatment approaches for T2DM continues to be important, due to the growing prevalence of this condition (in the United States in 2014, nearly 30-million people had diabetes) [1]. Blood glucose control is central to disease management, with target glycated hemoglobin (HbA1c) values personalized for individual patients, since the widely cited goal of HbA1c 10.0% (>86 mmol/mol).

Postgrad Med, 2015; 127(3):277–281

sitagliptin – HbA1c open-label controlled

Study design This was a 24-week, double-blind, parallel-group, randomized, Phase III, multicenter trial enrolling adults with T2DM from nine countries.

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Study participants Eligible patients had received no pharmacological treatment for diabetes for 12 weeks before starting study treatment, had a body mass index £45 kg/m2, and had insufficient glycemic control despite diet and exercise. Exclusion criteria included: uncontrolled hyperglycemia (glucose concentration >240 mg/dL [>13.3 mmol/L] after an overnight fast during a 2-week placebo run-in phase, confirmed by a second measurement); estimated glomerular filtration rate (eGFR, depending on country) of 86 mmol/mol) were not randomized and all received openlabel empagliflozin 25 mg (n = 87).

Data application in practice In the United States and the European Union, empagliflozin is recommended for the treatment of adult patients with T2DM to improve glycemic control [7]. In the United States, empagliflozin may be used as an adjunct to diet and exercise [9]. In the European Union, empagliflozin is recommended as monotherapy in patients with inadequate glycemic control despite diet and exercise alone and in whom metformin is not tolerated [10]. Additionally, in the European Union, empagliflozin may be used as add-on therapy in combination with other antihyperglycemic agents, when these, together with diet and exercise, do not provide adequate glycemic control [10]. The recommended starting dose is 10 mg/day in the United States [9] and in the European Union (as monotherapy or in combination with other antihyperglycemic agents, including insulin) [10]. In both regions, in patients who tolerate this dose and who require tighter glycemic control, the dose may be increased to a maximum of 25 mg/day [9,10] (in the European Union, subject to an eGFR of ‡60 mL/min/1.73 m2) [10]. If empagliflozin is used in combination with a sulfonylurea or with insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia [9,10].

In the United States, empagliflozin should not be initiated in individuals with an eGFR of

Review of empagliflozin monotherapy for previously untreated patients with type 2 diabetes mellitus: Comparison with sitagliptin.

This Practice Pearl provides a review and brief commentary of the 24-week, double-blind, parallel-group, randomized, Phase III study by Roden et al., ...
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