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Pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, and simvastatin following co-administration in healthy volunteers.
- Source :
-
International journal of clinical pharmacology and therapeutics [Int J Clin Pharmacol Ther] 2014 Nov; Vol. 52 (11), pp. 973-80. - Publication Year :
- 2014
-
Abstract
- Objective: This study was undertaken to investigate potential drugdrug interactions between the sodium glucose cotransporter 2 inhibitor empagliflozin and simvastatin.<br />Materials and Methods: In this open-label, randomized crossover trial, healthy volunteers (median (range) age 36.5 (20 - 50) years) received 3 single-dose treatments: 25 mg empagliflozin (n = 18), 40 mg simvastatin (n = 17), and 25 mg empagliflozin with 40 mg simvastatin (n = 18).<br />Results: Based on standard criteria, simvastatin had no effect on empagliflozin area under the plasma concentration-time curve (AUC(0-∞), adjusted geometric mean ratio (GMR): 102.05; 90% CI: 98.90 - 105.29) or maximum plasma concentration (C(max), GMR: 109.49; 90% CI: 96.91 - 123.69). There were only minor deviations in simvastatin AUC(0-∞) (GMR: 101.26; 90% CI: 80.06 - 128.07) and C(max) (GMR: 97.18; 90% CI: 76.30 - 123.77) when co-administered with empagliflozin. Empagliflozin had no effect on AUC(0-∞) (GMR: 104.87; 90% CI: 90.09 - 122.07) or C(max) (GMR: 97.27; 90% CI: 84.90 - 111.44) of simvastatin acid, the active metabolite of simvastatin. Adverse events (AEs) were reported for 6 subjects on empagliflozin, 4 on simvastatin, and 5 on co-administered treatment. No serious AEs or investigator-defined drug-related AEs were reported.<br />Conclusion: No relevant drug-drug interaction was observed, and pharmacokinetic results suggest that no dose adjustments for either drug are necessary when empagliflozin and simvastatin are co-administered. Empagliflozin was well tolerated when administered alone or in combination with simvastatin.
- Subjects :
- Adult
Benzhydryl Compounds administration & dosage
Benzhydryl Compounds adverse effects
Cross-Over Studies
Drug Interactions
Female
Glucosides administration & dosage
Glucosides adverse effects
Healthy Volunteers
Humans
Male
Middle Aged
Simvastatin administration & dosage
Simvastatin adverse effects
Simvastatin analogs & derivatives
Benzhydryl Compounds pharmacokinetics
Glucosides pharmacokinetics
Simvastatin pharmacokinetics
Sodium-Glucose Transporter 2 Inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 0946-1965
- Volume :
- 52
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- International journal of clinical pharmacology and therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 25161155
- Full Text :
- https://doi.org/10.5414/CP202117