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Pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, and simvastatin following co-administration in healthy volunteers.
Int J Clin Pharmacol Ther. 2014 Nov; 52(11):973-80.IJ

Abstract

OBJECTIVE

This study was undertaken to investigate potential drugdrug interactions between the sodium glucose cotransporter 2 inhibitor empagliflozin and simvastatin.

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).

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.

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.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25161155

Citation

Macha, Sreeraj, et al. "Pharmacokinetics of Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, and Simvastatin Following Co-administration in Healthy Volunteers." International Journal of Clinical Pharmacology and Therapeutics, vol. 52, no. 11, 2014, pp. 973-80.
Macha S, Lang B, Pinnetti S, et al. Pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, and simvastatin following co-administration in healthy volunteers. Int J Clin Pharmacol Ther. 2014;52(11):973-80.
Macha, S., Lang, B., Pinnetti, S., & Broedl, U. C. (2014). Pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, and simvastatin following co-administration in healthy volunteers. International Journal of Clinical Pharmacology and Therapeutics, 52(11), 973-80. https://doi.org/10.5414/CP202117
Macha S, et al. Pharmacokinetics of Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, and Simvastatin Following Co-administration in Healthy Volunteers. Int J Clin Pharmacol Ther. 2014;52(11):973-80. PubMed PMID: 25161155.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, and simvastatin following co-administration in healthy volunteers. AU - Macha,Sreeraj, AU - Lang,Benjamin, AU - Pinnetti,Sabine, AU - Broedl,Uli C, PY - 2014/10/21/accepted PY - 2014/8/28/entrez PY - 2014/8/28/pubmed PY - 2016/6/9/medline SP - 973 EP - 80 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 52 IS - 11 N2 - OBJECTIVE: This study was undertaken to investigate potential drugdrug interactions between the sodium glucose cotransporter 2 inhibitor empagliflozin and simvastatin. 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). 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. 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. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/25161155/Pharmacokinetics_of_empagliflozin_a_sodium_glucose_cotransporter_2_inhibitor_and_simvastatin_following_co_administration_in_healthy_volunteers_ L2 - http://www.dustri.com/nc/journals-in-english?artId=12623 DB - PRIME DP - Unbound Medicine ER -