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Interaction Study between Digoxin and a Preparation of Hawthorn ( Crataegus oxyacantha )
Author(s) -
Tankanow Roberta,
Tamer Helen R.,
Streetman Daniel S.,
Smith Scott G.,
Welton Janice L.,
Annesley Thomas,
Aaronson Keith D.,
Bleske Barry E.
Publication year - 2003
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270003253417
Subject(s) - digoxin , crataegus , pharmacokinetics , medicine , crossover study , pharmacology , heart failure , traditional medicine , placebo , alternative medicine , pathology
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 AUC 0‐∞ , C max ‐C min , C min , and renal clearance for the D group were 79 ± 26 mcg•h/L, 1.4 ± 0.7mcg/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, maybe coadministered safely.