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The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study

Overview of attention for article published in Cardiovascular Diabetology, January 2013
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Title
The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study
Published in
Cardiovascular Diabetology, January 2013
DOI 10.1186/1475-2840-12-70
Pubmed ID
Authors

Arne Ring, Tobias Brand, Sreeraj Macha, Kerstin Breithaupt-Groegler, Gudrun Simons, Beate Walter, Hans J Woerle, Uli C Broedl

Abstract

BACKGROUND: Empagliflozin is a potent, selective sodium glucose cotransporter 2 (SGLT2) inhibitor in development as an oral antidiabetic treatment. This QT interval study assessed potential effects of empagliflozin on ventricular repolarisation and other electrocardiogram (ECG) parameters. METHODS: A randomised, placebo-controlled, single-dose, double-blind, five-period crossover study incorporating a novel double-placebo period design to reduce sample size, while maintaining full statistical power. Treatments: single empagliflozin doses of 25 mg (therapeutic) and 200 mg (supratherapeutic), matching placebo and open-label moxifloxacin 400 mg (positive control). Triplicate 12-lead ECGs of 10 second duration were recorded at baseline and during the first 24 hours after dosing. The primary endpoint was mean change from baseline (MCfB) in the population heart rate-corrected QT interval (QTcN) between 1--4 hours after dosing. RESULTS: Thirty volunteers (16 male, 14 female, mean [range] age: 34.5 [18--52] years) were randomised. The placebo-corrected MCfB in QTcN 1--4 hours after dosing was 0.6 (90% CI: -0.7, 1.9) ms and -0.2 (-1.4, 0.9) ms for empagliflozin 25 mg and 200 mg, respectively, below the ICH E14 defined threshold of regulatory concern 10 ms. Assay sensitivity was confirmed by a placebo-corrected MCfB in QTcN 2--4 hours post-dose of 12.4 (10.7, 14.1) ms with moxifloxacin 400 mg. Empagliflozin tolerability was good for all volunteers; 23.3% experienced adverse events (AEs) with empagliflozin and 27.6% with placebo. The most frequent AE was nasopharyngitis.Conclusions/interpretation: Single doses of empagliflozin 25 mg and 200 mg were not associated with QTcN prolongation and were well tolerated in healthy volunteers.Trial registration: ClinicalTrials.gov: NCT01195675.

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Mendeley readers

The data shown below were compiled from readership statistics for 55 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 55 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 9 16%
Other 8 15%
Student > Bachelor 8 15%
Student > Ph. D. Student 7 13%
Researcher 6 11%
Other 9 16%
Unknown 8 15%
Readers by discipline Count As %
Medicine and Dentistry 27 49%
Pharmacology, Toxicology and Pharmaceutical Science 5 9%
Computer Science 3 5%
Biochemistry, Genetics and Molecular Biology 3 5%
Chemistry 2 4%
Other 6 11%
Unknown 9 16%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 20 November 2013.
All research outputs
#3,065,678
of 4,507,509 outputs
Outputs from Cardiovascular Diabetology
#235
of 400 outputs
Outputs of similar age
#67,801
of 102,370 outputs
Outputs of similar age from Cardiovascular Diabetology
#14
of 22 outputs
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