Efficacy and safety of empagliflozin in combination with other oral hypoglycaemic agents in patients with type 2 diabetes mellitus

Romera, Irene and Javier Ampudia-Blasco, Francisco and Pérez Pérez, Antonio and Ariño, Bernat and Pfarr, Egon and Giljanovic Kis, Sanja and Naderali, Ebrahim (2016) Efficacy and safety of empagliflozin in combination with other oral hypoglycaemic agents in patients with type 2 diabetes mellitus. Endocrinología y Nutrición (English Edition), 63 (10). pp. 519-526. ISSN 1575-0922

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Abstract

Abstract and keywords Objective: To analyse the efficacy and safety of empagliflozin in combination with other oral hypoglycaemic agents in patients with type 2 diabetes mellitus (T2DM). Methods: Pooled analysis of three phase III trials in patients with T2DM (n = 1,801) who received placebo, empagliflozin 10 mg or empagliflozin 25 mg once daily for 24 weeks, in combination with metformin, metformin + sulphonylurea or pioglitazone ± metformin. Results: Empagliflozin significantly reduced HbA1c (adjusted mean reduction vs placebo: with empagliflozin 10 mg, –0.58% [95% CI: –0.66; –0.49]; p < 0.0001 and with empagliflozin 25mg, –0.62% [95% CI: –0.70; –0.53], p < 0.0001), weight (adjusted mean reduction vs placebo: with empagliflozin 10 mg, –1.77 kg [95% CI: –2.05; –1.48]; p < 0.0001 and with empagliflozin 25 mg, –1.96 kg [95% CI: –2.24; –1.67], p < 0.0001), systolic blood pressure (SBP) and diastolic blood pressure (DBP). The frequency of adverse effects (AEs) was 64% with placebo, 63.9% with empagliflozin 10 mg and 60.9% with empagliflozin 25 mg. Confirmed episodes of hypoglycaemia (≤ 70 mg/dl and/or requiring care) occurred in 3.9% of patients with placebo, 6.9% of patients with empagliflozin 10 mg and 5.3% of patients with empagliflozin 25 mg. Urinary tract infections were reported in 9.4% of patients with placebo, 10.2% of patients with empagliflozin 10 mg and 8.3% of patients with empagliflozin 25 mg. Genital infections were reported in 1.0% of patients with placebo, 4.6% of patients with empagliflozin 10 mg and 3.5% of patients with empagliflozin 25 mg. Conclusions: Empagliflozin in combination with other oral treatments versus placebo significantly decreased HbA1c, body weight and SBP/DBP with an overall good safety and tolerability profile.

Item Type: Article
Additional Information and Comments: NOTICE: this is the author’s version of a work that was accepted for publication in Endocrinología y Nutrición (English Edition). Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Endocrinología y Nutrición (English Edition) 63 (10) December, 2016 http://dx.doi.org/10.1016/j.endoen.2016.11.001
Keywords: Empagliflozin, combination treatment, type 2 diabetes mellitus, SGLT2 inhibitors
Faculty / Department: Faculty of Science > School of Health Sciences
Depositing User: Ebrahim Naderali
Date Deposited: 24 Feb 2017 15:05
Last Modified: 24 Feb 2017 15:05
URI: http://hira.hope.ac.uk/id/eprint/1863

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