The Effect of Compound Danshen Dripping Pills on the Dose and Concentration of Warfarin in Patients with Various Genetic Polymorphisms |
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| Affiliation: | 1. Department of Clinical Pharmacology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China;2. State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin, China;3. Department of Cardiology, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China;4. Department of Cardiology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China;1. ACS Group, Duluth, GA, USA;2. Health Analytics LLC, Columbia, MD, USA;3. Janssen Scientific Affairs LLC, Horsham, PA, USA;1. Motif BioSciences, Princeton, NJ, USA;2. Rutgers New Jersey Medical School, Trenton, NJ, USA;3. Veristat, Southborough, MA, USA;4. Duke University Medical Center, Durham, NC, USA;1. Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network, Allentown, PA, USA;2. , Lehigh Valley Hospital and Health Network, Allentown, USA;3. Network Office of Research and Innovation, Lehigh Valley Hospital and Health Network, Allentown, PA, USA;4. Department of Internal Medicine, Lehigh Valley Hospital and Health Network, Allentown, PA, USA;1. Divisions of Basic Chinese Medicine, National Research Institute of Chinese Medicine, Taipei, Taiwan, ROC;2. Chinese Medicinal Chemistry, National Research Institute of Chinese Medicine, Taipei, Taiwan, ROC;3. School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan City, Taiwan, ROC;4. Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan, ROC;5. School of Pharmacy, National Defense Medical Center, Taipei, Taiwan, ROC;6. Department of Pharmacology, School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC;7. Institute of Biopharmaceutical Sciences, School of Pharmaceutical Science, National Yang-Ming University, Taipei, Taiwan, ROC;8. Department of Life Sciences and Institute of Genome Sciences, School of Life Sciences, National Yang-Ming University, Taipei, Taiwan, ROC;9. Institute of Medical Sciences, School of Medicine, Taipei Medical University, Taipei, Taiwan, ROC;1. Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA;2. Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA;3. Department of Emergency Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA;4. Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA;5. Department of Medicine, Denver Health Medical Center, Denver, CO, USA |
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| Abstract: | PurposeThe combination of warfarin and compound Danshen dripping pill (CDDP) is helpful for patients with both coronary heart disease (CHD) and atrial fibrillation (AF). The main adverse drug reaction of warfarin is bleeding because of its narrow therapeutic index. The safety of a combination therapy with warfarin and CDDP is always a concern. Our previous research showed that the combination of warfarin and CDDP improved the quality of life for patients with both CHD and AF. This study describes the changes in dose and concentration of warfarin necessary and evaluates bleeding risk when warfarin is given concomitantly with CDDP.MethodsAn ultra-performance liquid chromatography–MS/MS method with a chiral column was developed to assay the concentration of S-warfarin and R-warfarin in human plasma simultaneously. The method was applied to compare the concentration of warfarin in patients taking warfarin combined with CDDP and without CDDP. International normalized ratio (INR) values were monitored to evaluate bleeding risk. Paired t tests were then used to compare the dose and the concentration in 2 periods. Moreover, patients with VKORC1, CYP2C9*3, CYP4F2, EPHX1, and PROC gene polymorphisms were evaluated to determine interactions.FindingsThe results indicate that the dose of warfarin had no significant change with or without CDDP. Also, the peak concentrations of S-warfarin and total warfarin were significantly different in CYP4F2 C/C patients, but there was no significant difference identified in other genetic groups. No bleeding occurred in the study.ImplicationsThe dose of warfarin would be sustainable when combined with CDDP, because CDDP did not affect concentration of warfarin significantly in most patients and the change of INR was not significant.China Clinical Trial Registry identifierChiCTR-ONRC-13003523. |
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| Keywords: | compound Danshen dripping pills concentration dose gene warfarin |
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