ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2011
Evaluation of the effect of dapagliflozin on cardiac repolarization: a thorough QT/QTc study.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03021616 (Evaluation of Energy Drink Consumption on Electrocardiographic, Vascular and Hematologic Parameters in Young Healthy Volunteers), which is not on this map. Cited by 15 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of Energy Drink Consumption on Electrocardiographic, Vascular and Hematologic Parameters in Young Healthy Volunteers: A Randomized, Double Blind, Active-Controlled, Crossover Study
Who cites it
15 citing papers in PubMed.
- Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023Trial
- Comparative study of cardio-protective effect of metformin versus dapagliflozin in experimentally induced myocardial infarction in diabetic rats.BMC pharmacology & toxicology · 2026Article
- Dapagliflozin and atrial fibrillation: elevated dosing to achieve class I antiarrhythmic effects?Basic research in cardiology · 2024Article
- Electrophysiological Effects of the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitor Dapagliflozin on Human Cardiac Potassium Channels.International journal of molecular sciences · 2024Article
- Dapagliflozin Pretreatment Prevents Cardiac Electrophysiological Changes in a Diet and Streptozotocin Induction of Type 2 Diabetes in Rats: A Potential New First-Line?Journal of experimental pharmacology · 2024Article
- Metformin and Dapagliflozin Attenuate Doxorubicin-Induced Acute Cardiotoxicity in Wistar Rats: An Electrocardiographic, Biochemical, and Histopathological Approach.Cardiovascular toxicology · 2023Article
- Potential favorable action of sodium-glucose cotransporter-2 inhibitors on sudden cardiac death: a brief overview.Frontiers in cardiovascular medicine · 2023Review
- Electrocardiographic changes associated with SGLT2 inhibitors and non-SGLT2 inhibitors: A multi-center retrospective study.Frontiers in cardiovascular medicine · 2022Article
- Dapagliflozin reduces the amplitude of shortening and Ca(2+) transient in ventricular myocytes from streptozotocin-induced diabetic rats.Molecular and cellular biochemistry · 2015Article
- Dapagliflozin in patients with type 2 diabetes mellitus.Therapeutic advances in endocrinology and metabolism · 2015Review
- Safety profile of dapagliflozin for type 2 diabetes: pooled analysis of clinical studies for overall safety and rare events.Drug safety · 2014Article
- Clinical pharmacokinetics and pharmacodynamics of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2.Clinical pharmacokinetics · 2014 · on this mapReview
- The effects of active metabolites on parameter estimation in linear mixed effect models of concentration-QT analyses.Journal of pharmacokinetics and pharmacodynamics · 2013Article
- Dapagliflozin: a review of its use in type 2 diabetes mellitus.Drugs · 2012 · on this mapReview
- Clinical potential of sodium-glucose cotransporter 2 inhibitors in the management of type 2 diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2012Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDapagliflozin is a first-in-class sodium-glucose transporter 2 (SGLT2) inhibitor under investigation for the treatment of type 2 diabetes mellitus. A thorough QTc study was conducted, according to International Conference on Harmonization E14 guidelines, to characterize the effect of dapagliflozin on cardiac repolarization.
methodsThe present study was a double-blind, four-period, placebo-controlled crossover study at a single-center inpatient clinical pharmacology unit. The study enrolled 50 healthy men who were randomized to receive sequences of single doses of dapagliflozin 150 mg, dapagliflozin 20 mg, moxifloxacin 400 mg, and placebo. The sequences were randomized based on the Williams design for a cross-over study to reduce the "carryover" effects from drug-to-drug even with sufficient washout periods. Digital 12-lead electrocardiograms were recorded at nine time points over 24 hours in each period. QT intervals were corrected for heart rate using a study-specific correction factor (QTcX) and Fridericia's formula.
resultsFor dapagliflozin, the upper bound of the one-sided 95% confidence interval (CI) for time-matched, placebo-subtracted, baseline adjusted QTc intervals (ΔΔQTc) was <10 ms. ΔΔQTc was independent of dapagliflozin concentrations. No QTc thresholds >450 ms or QTc increases >30 ms were observed. Moxifloxacin increased the mean QTcX interval by 7.7 ms (lower bound 90% CI, 6.2 ms) over 1-4 hours after dosing, confirming assay sensitivity.
conclusionDapagliflozin, at supratherapeutic doses, does not have a clinically significant effect on the QT interval in healthy subjects.
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Registered trials
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