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HERBAL MEDICINE

Interaction Study between Digoxin and a Preparation of Hawthorn (Crataegus oxyacantha)

Roberta Tankanow, MS, Helen R. Tamer, PharmD, Daniel S. Streetman, PharmD, Scott G. Smith, Janice L. Welton, Thomas Annesley, PhD, Keith D. Aaronson, MD and Barry E. Bleske, PharmD, FCCP

From the University of Michigan College of Pharmacy and University of Michigan Health Systems, Ann Arbor, Michigan (Ms. Tankanow, Dr. Tamer, Dr. Streetman, Mr. Smith, Ms. Welton, Dr. Bleske) and the Department of Pathology (Dr. Annesley) and Department of Internal Medicine (Dr. Aaronson), University of Michigan Health Systems, Ann Arbor, Michigan.

Hawthorn, an herbal supplement, is currently being evaluated for the treatment of heart failure. The flavonoid components of hawthorn may be responsible for hawthorn's beneficial effects in the treatment of heart failure. However, these components may also affect P-glycoprotein function and cause interactions with drugs that are P-glycoprotein substrates, such as digoxin, which is also used to treat heart failure. Therefore, the purpose of this study was to determine the effect of hawthorn on digoxin pharmacokinetic parameters. A randomized, crossover trial with 8 healthy volunteers was performed evaluating digoxin 0.25 mg alone (D) for 10 days and digoxin 0.25 mg with Crataegus special extract WS 1442 (hawthorn leaves with flowers; Dr. Willmar Schwabe Pharmaceuticals) 450 mg twice daily (D + H) for 21 days. Pharmacokinetic studies were performed for 72 hours. There were no statistically significant differences in any measured pharmacokinetic parameters. The AUC0-{infty}, Cmax-Cmin, Cmin, and renal clearance for the D group were 79 26 mcg•h/L, 1.4 ± 0.7 mcg/L, 0.84 ± 0.2 mcg/L, and 74 ± 10 mL/min versus 73 ± 20 mcg•h/L, 1.1 ± 0.1 mcg/L, 0.65 ± 0.2 mcg/L, and 81 ± 22 mL/min for the D + H group, respectively (p> 0.05). Following 3 weeks of concomitant therapy, hawthorn did not significantly alter the pharmacokinetic parameters for digoxin. This suggests that both hawthorn and digoxin, in the doses and dosage form studied, may be coadministered safely.

Key Words: Hawthorn • digoxin • pharmacokinetics • heart failure

Address for reprints: Barry E. Bleske, PharmD, University of Michigan, College of Pharmacy, 428 Church Street, Ann Arbor, MI 48109-1065.


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