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Lack of drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and warfarin in healthy volunteers.
Diabetes Obes Metab. 2013 Apr; 15(4):316-23.DO

Abstract

AIM

To investigate potential drug-drug interactions between empagliflozin and warfarin.

METHODS

Healthy subjects (n = 18) received empagliflozin 25 mg qd for 5 days (treatment A), followed by empagliflozin 25 mg qd for 7 days (days 6-12) with a single 25 mg dose of warfarin on day 6 (treatment B), and a single 25 mg dose of warfarin alone (treatment C), in an open-label, crossover study. Subjects received treatments in sequence AB_C or C_AB with a washout period of ≥14 days between AB and C or C and AB.

RESULTS

Warfarin had no effect on empagliflozin area under concentration-time curve or maximum plasma concentration at steady-state (AUC(τ,ss) or C(max,ss)): geometric mean ratios (GMRs) (90% confidence intervals [CI]) were 100.89% (96.86, 105.10) and 100.64% (89.79, 112.80), respectively. Empagliflozin had no effect on AUC from 0 h to infinity (AUC(0-∞)) or C(max) for R- or S-warfarin (GMRs [90% CI] for AUC(0-∞): 98.49% [95.29, 101.80] and 95.88% [93.40, 98.43], respectively; C(max): 97.89% [91.12, 105.15] and 98.88% [91.84, 106.47], respectively). Empagliflozin had no clinically relevant effects on warfarin's anticoagulant activity (international normalised ratio [INR]) (GMR [95% CI] for peak INR: 0.87 [0.73, 1.04]; area under the effect-time curve from 0 to 168 h: 0.88 [0.79, 0.98]. No drug-related adverse events were reported for empagliflozin after monotherapy or combined administration. The combination of empagliflozin and warfarin was well tolerated.

CONCLUSIONS

No drug-drug interactions were observed between empagliflozin and warfarin, indicating that empagliflozin and warfarin can be co-administered without dosage adjustments of either drug.

Authors+Show Affiliations

Clinical Pharmacokinetics and Pharmacodynamics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. sreeraj.macha@boehringer-ingelheim.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23094794

Citation

Macha, S, et al. "Lack of Drug-drug Interaction Between Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, and Warfarin in Healthy Volunteers." Diabetes, Obesity & Metabolism, vol. 15, no. 4, 2013, pp. 316-23.
Macha S, Rose P, Mattheus M, et al. Lack of drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and warfarin in healthy volunteers. Diabetes Obes Metab. 2013;15(4):316-23.
Macha, S., Rose, P., Mattheus, M., Pinnetti, S., & Woerle, H. J. (2013). Lack of drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and warfarin in healthy volunteers. Diabetes, Obesity & Metabolism, 15(4), 316-23. https://doi.org/10.1111/dom.12028
Macha S, et al. Lack of Drug-drug Interaction Between Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, and Warfarin in Healthy Volunteers. Diabetes Obes Metab. 2013;15(4):316-23. PubMed PMID: 23094794.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lack of drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and warfarin in healthy volunteers. AU - Macha,S, AU - Rose,P, AU - Mattheus,M, AU - Pinnetti,S, AU - Woerle,H J, Y1 - 2012/11/22/ PY - 2012/06/29/received PY - 2012/08/06/revised PY - 2012/10/10/accepted PY - 2012/10/26/entrez PY - 2012/10/26/pubmed PY - 2013/10/1/medline SP - 316 EP - 23 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 15 IS - 4 N2 - AIM: To investigate potential drug-drug interactions between empagliflozin and warfarin. METHODS: Healthy subjects (n = 18) received empagliflozin 25 mg qd for 5 days (treatment A), followed by empagliflozin 25 mg qd for 7 days (days 6-12) with a single 25 mg dose of warfarin on day 6 (treatment B), and a single 25 mg dose of warfarin alone (treatment C), in an open-label, crossover study. Subjects received treatments in sequence AB_C or C_AB with a washout period of ≥14 days between AB and C or C and AB. RESULTS: Warfarin had no effect on empagliflozin area under concentration-time curve or maximum plasma concentration at steady-state (AUC(τ,ss) or C(max,ss)): geometric mean ratios (GMRs) (90% confidence intervals [CI]) were 100.89% (96.86, 105.10) and 100.64% (89.79, 112.80), respectively. Empagliflozin had no effect on AUC from 0 h to infinity (AUC(0-∞)) or C(max) for R- or S-warfarin (GMRs [90% CI] for AUC(0-∞): 98.49% [95.29, 101.80] and 95.88% [93.40, 98.43], respectively; C(max): 97.89% [91.12, 105.15] and 98.88% [91.84, 106.47], respectively). Empagliflozin had no clinically relevant effects on warfarin's anticoagulant activity (international normalised ratio [INR]) (GMR [95% CI] for peak INR: 0.87 [0.73, 1.04]; area under the effect-time curve from 0 to 168 h: 0.88 [0.79, 0.98]. No drug-related adverse events were reported for empagliflozin after monotherapy or combined administration. The combination of empagliflozin and warfarin was well tolerated. CONCLUSIONS: No drug-drug interactions were observed between empagliflozin and warfarin, indicating that empagliflozin and warfarin can be co-administered without dosage adjustments of either drug. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/23094794/Lack_of_drug_drug_interaction_between_empagliflozin_a_sodium_glucose_cotransporter_2_inhibitor_and_warfarin_in_healthy_volunteers_ L2 - https://doi.org/10.1111/dom.12028 DB - PRIME DP - Unbound Medicine ER -