To determine if the chronic administration of enalapril, an inhibitor of angiotensin
converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology
patients who have received anthracyclines, and who are not currently on digoxin, diuretics,
or vasodilators for heart failure.
Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
National Center for Research Resources (NCRR)
Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American
herbal medicine practice. Some of its cardiac uses include the treatment of high and low
blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used
as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To
date, little information is known about the effect of hawthorn when taken with other drugs
and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is
to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects
will be recruited by advertisement. The design of the study will include a 10-day and a
three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special
extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover.
There will be a three-week washout period in between treatment phases. On day 10 (phase I)
and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic
analysis. The plasma samples will be measured for digoxin concentration. Additionally, the
subjects will be assessed for any clinical toxicities or adverse events. The significance of
this study is to provide the clinician with information regarding the safe use of digoxin in
combination with the herbal supplement, hawthorn.
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