Is it safe to take Danshen-gegen product with warfarin and aspirin? A pilot study in human subject
Refereed conference paper presented and published in conference proceedings

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AbstractDanshen-Gegen (DG) product, containing Salviae Miltiorrhizae Radix et Rhizoma and Puerariae Lobatae Radix, is a Compound Chinese Medicine targeting cardiovascular diseases (CVD). Warfarin and aspirin are commonly used drugs to prevent blood clots. In integrative medicine clinical practice, DG is co-administrated with warfarin or aspirin to reduce the risk of heart attack or stroke. Significantly decreased Cmax, AUC0-t and the prothrombin time of warfarin were observed in our preliminary animal study, indicating that the co-administration of DG with warfarin could cause significant pharmacokinetic (PK) and pharmacodynamics (PD) herb-drug interactions in rats. To further explore the interaction between DG and warfarin in clinical settings, we proposed the current study to examine whether such PK and PD interaction would happen in healthy male subjects. A multiple dose (5 days), five-session design has been performed, in which 14 healthy subjects received aspirin alone (100 mg once daily for 5 days), DG alone (750 mg twice daily for 5 day), aspirin in combination with DG product, warfarin alone (1 mg once daily for 5 days) and warfarin in combination with DG, respectively. There is a washout period of 2 weeks between sessions. During the combination treatment with DG and aspirin/warfarin, DG was given 2 h post that of aspirin/warfarin. Following first dosing on Day 5, plasma samples were collected at different time intervals till 12 hours (aspirin)/168 hours (warfarin). For the pharmacodynamics measurement, whole blood of each subject was collected at 30 min after DG dosing or at 2.5h after aspirin/warfarin dosing for monitoring of the platelet function and soluble Thrombomodulin (sTM) concentrations. Based on the observed AUC0-t and Cmax and Tmax of the studied compounds, DG could moderately increase AUC0-t of aspirin and decrease AUC0-t of 7-hydroxyl warfarin with no impact on that of salicylic acid and warfarin’s systemic exposure; Warfarin (rather than aspirin) could greatly increase the systemic exposure of Danshensu, the marker compound of DG; Co-administration of aspirin/warfarin with DG had synergistic effect on TXB2 inhibition by aspirin and offset enhanced sTM by warfarin. Our study indicated that co-administration of DG with aspirin/warfarin could cause potential pharmacokinetic and pharmacodynamic herb–drug interactions in healthy human subjects with no higher risk of bleeding.
All Author(s) ListZhang Y, Mok RY, Zhang Z, Ge B, Leung PC, Fung KP, Lau CBS, Lee VHL, Lin Z, Wong RSM, Zho Z
Name of ConferenceHealth Research Symposium 2017
Start Date of Conference16/06/2017
End Date of Conference16/06/2017
Place of ConferenceHong Kong
Country/Region of ConferenceHong Kong
LanguagesEnglish-United Kingdom

Last updated on 2018-02-10 at 12:27