DIGITEK SUMMARY
DIGITEK (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of
Digitalis lanata. The term "digitalis" is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence "glycosides").
Heart Failure: DIGITEK is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.
Atrial Fibrillation: DIGITEK is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.
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NEWS HIGHLIGHTSMedia Articles Related to Digitek (Digoxin)
Congestive Heart Failure
Source: MedicineNet Amyloidosis Specialty [2008.06.23]
Title: Congestive Heart Failure
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 6/23/2008
Published Studies Related to Digitek (Digoxin)
Intravenous diltiazem is superior to intravenous amiodarone or digoxin for achieving ventricular rate control in patients with acute uncomplicated atrial fibrillation. [2009.07]
OBJECTIVES: To compare the clinical efficacy of intravenous diltiazem, digoxin, and amiodarone for acute ventricular rate (VR) control in patients with acute symptomatic atrial fibrillation (AF) necessitating hospitalization... CONCLUSIONS: As compared with digoxin and amiodarone, intravenous diltiazem was safe and effective in achieving VR control to improve symptoms and to reduce hospital stay in patients with acute AF.
The hemodynamic effects of intravenous digoxin-binding fab immunoglobulin in severe preeclampsia: a double-blind, randomized, clinical trial. [2009.04]
OBJECTIVE: An endogenous digitalis-like factor (EDLF) has been implicated in the pathophysiology of preeclampsia (PE). This hypothesis is supported by two cases of preeclampsia in which administration of digoxin immune Fab (DIF) reduced mean arterial pressure (MAP)... CONCLUSION: These results support the hypothesis that EDLF contributes to the elevated blood pressure in preeclampsia and suggests a possible role for DIF as a treatment for this condition.
The hemodynamic effects of intravenous digoxin-binding fab immunoglobulin in severe preeclampsia: a double-blind, randomized, clinical trial. [2009.01.15]
Objective:An endogenous digitalis-like factor (EDLF) has been implicated in the pathophysiology of preeclampsia (PE). This hypothesis is supported by two cases of preeclampsia in which administration of digoxin immune Fab (DIF) reduced mean arterial pressure (MAP).Study Design:To study this observation further, we performed a double-blind, placebo-controlled, randomized clinical trial to examine the effects on MAP of intravenous DIF given after delivery in 26 subjects with severe preeclampsia...
Effectiveness of digoxin in reducing one-year mortality in chronic heart failure in the Digitalis Investigation Group trial. [2009.01.01]
Post hoc analyses of the Digitalis Investigation Group (DIG) trial indicate that digoxin at low (0.5 to 0.9 ng/ml) serum digoxin concentration (SDC) reduces mortality, which is eliminated at higher (>or=1 ng/ml) SDC, and that low-dose digoxin (<or=0.125 mg/day) predicts low SDC... Randomized clinical trials are needed to determine the effect of low-dose digoxin in contemporary patients with chronic HF.
Digoxin and reduction of heart failure hospitalization in chronic systolic and diastolic heart failure. [2008.12.15]
In the Digitalis Investigation Group trial, digoxin-associated decrease in the combined end point of heart failure (HF) hospitalization or HF mortality was significant in systolic but not in diastolic HF. To assess whether this apparent disparity could be explained by differences in baseline characteristics and sample size, we used propensity score matching to assemble a cohort of 916 pairs of patients with systolic and diastolic HF who were balanced in all measured baseline covariates...
Clinical Trials Related to Digitek (Digoxin)
Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects [Not yet recruiting]
This study has been designed to confirm, in healthy subjects, the lack of a clinically
important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial
dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0. 125 mg QD, a
sensitive P-gp substrate recommended by FDA.
Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer [Recruiting]
This is a two part study looking at the effect of lapatinib on concentrations of digoxin in
the blood when both drugs are dosed together in Part 1; and looking at the safety and
antitumor effect of lapatinib when used together with possible additional anticancer therapy
as chosen at the doctor's discretion.
Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin [Recruiting]
Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn [Completed]
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.
An Interaction Study With Digoxin and AZD1305 [Not yet recruiting]
The primary purpose of this study is to learn more about how digoxin is handled by the body,
i. e. absorption, distribution, metabolism and excretion, when administered alone and in
combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled
by the body when administered alone and in combination with digoxin and to learn more about
how AZD1305 and digoxin administered alone and in combination affect the body.
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