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PubMed1990

Ibopamine versus digoxin in the treatment of mild congestive heart failure. A double-blind, randomized, placebo-controlled trial.

We describe a randomized double-blind 4-week study on the efficacy of monotherapy with ibopamine 200 mg b.i.d. in comparison to placebo and open titrated digoxin in patients with mild congestive heart failure NYHA class I and II. A total of 60 patients (22 males and 38 females) were evaluated for body weight, signs and symptoms score and the need for additional diuretic treatment for adequate symptom control. Mean decreases in body weight in the ibopamine group exceeded mean decreases in body weight in the placebo group (3.03 kg). The signs and symptoms score was improved in 7 out of 20 patients in the placebo group, in all patients treated with ibopamine and in 21 of 22 patients of the digoxin subgroup while the patient-questionnaire score improved in 23.5% (placebo), 100% (ibopamine) and 81.2% (digoxin) of the cases, respectively. There were no treatment failures in the ibopamine and digoxin group. However, 8 of 20 patients receiving placebo had need of additional diuretic therapy. No adverse drug reactions were reported in the ibopamine-treated patients. We conclude that ibopamine monotherapy over 4 weeks has favourable effects on body weight and signs and symptoms of mild congestive heart failure without exerting major side effects. The efficacy is comparable to digoxin therapy.

Adult↗
PubMed1994

Comparative hemodynamic effects of intravenous digoxin and enoximone in severe chronic heart failure.

In order to compare the acute hemodynamic effects of digoxin (0.01 mg/kg) and enoximone (1 mg/kg), a phosphodiesterase inhibitor inotropic agent, in severe chronic congestive heart failure, 8 patients (male, mean age 56.7 years, sinus rhythm) were investigated with a randomized cross-over study. Peak effect of enoximone (30 min) in comparison to that of digoxin (90 min) resulted in a similar reduction of left-ventricular filling pressure (-27 vs. -28%) and mean pulmonary artery pressure (-23 vs. -24%). Pulmonary (-39 vs. -16%; p < 0.01) and systemic vascular resistance (-27 vs. -4%; p < 0.001) were significantly lowered by enoximone. Cardiac index (+30 vs. +6%; p < 0.001) and heart rate (+11 vs. -3%; p < 0.05) were increased significantly more by enoximone than by digoxin. Since enoximone resulted in an enhancement of cardiac performance greater than that produced by digoxin, enoximone could be a useful and powerful substitute for digoxin in the acute therapy of severe chronic congestive heart failure with sinus rhythm.

Adult↗
PubMed1985

Chromatographic characterization of endogenous digoxin-like immunoreactive substances present in serum and urine of infants using gel filtration with Sephadex G 25.

We assayed digoxin-like immunoreactivity in the serum of 19 healthy neonates (blood sample from umbilical cord), not receiving digoxin therapy, using a solid-phase radioimmunological method. In addition, urinary concentrations of a digoxin-like immunoreactive substance (DLIS) were assayed throughout the first 10 weeks of extrauterine life in 50 healthy infants. The mean (+/- SD) serum DLIS concentration obtained was 211 +/- 60 ng/l digoxin equivalents (d.e.) while, in the urinary samples of the first day of life, the mean concentration was 818 +/- 560 ng/l d.e. (n = 20). These DLIS values in infants were higher (about 5- to 10-fold) than those previously observed in adults. In addition, urinary DLIS values were very high in the first week of life and fell quite rapidly in the next weeks of life. We used serum and urine pools from neonates for gel filtration experiments using a Sephadex G 25 column. In the urine sample we found some immunoreactive peaks eluted at the end and after the region of salts, while the chromatographic profiles of the serum pool showed only a major peak eluted with the peak of proteins. After boiling, the same serum pool showed an elution pattern characterized by a smaller immunoreactive peak eluted with that of proteins and by other peaks similar to those observed for the urine sample. Our study demonstrated that a substance or more substances which cross-react with digoxin-specific antibodies are present in blood and urine of healthy infants. In addition, our chromatographic studies indicate that DLIS is probably a low molecular weight substance(s) which circulate(s) in blood bound to a higher molecular weight molecule.

Chromatography, Gel↗
PubMed1982

Total body digoxin clearance and steady-state concentrations in low birth weight infants.

Serial serum digoxin concentrations were measured over a 10-day period in 15 low birth weight infants requiring digoxin therapy. The calculated total body digoxin clearance (TBDC) was found to be highly dependent on gestational age and body weight, with dose-normalized, steady-state digoxin concentrations inversely related to the same factors. Because of the decreased TBDC in low birth weight infants, our data support the recent recommendations in the literature to reduce maintenance doses of digoxin in these infants. Our study has further demonstrated that the reduction should be proportional to both gestational age and body weight.

Birth Weight↗
PubMed1975

Effect of digoxin on atioventricular conduction. Studies in patients with and without cardiac autonomic innervation.

The effect of digoxin on atrioventricular (a-v) conduction was compared in five patients with an intact cardiac autonomic nervous system (Group I) and seven patients who had undergone cardiac transplantation (Group II), in whom we have previously shown the transplanted heart to be completely denervated. Small decreases in the atrial effective refractory period (ERP) (from 262 plus or minus 12 to 254 plus or minus 11 msec) and atrial functional refractory period (FRP) (from 304 plus or minus 12 msec) were observed in Group I patients after digoxin, but these changes were not significant. However, significant increases in the A-V nodal ERP (from 315 plus or minus 18 msec to 351 plus or minus 17 msec, P less than 0.05), and A-V nodal FRP (from 426 plus or minus 42 to 460 plus or minus 46 msec, P less than 0.01) were produced by digoxin and were unrelated to changes in cycle length. In Group II patients with denervated hearts, changes in atrial ERP (from 246 plus or minus 4 to 243 plus or minus 6 during spontaneous sinus rhythm; from 204 plus or minus 10 to 216 plus or minus 8 msec during atrial pacing) and atrial FRP (from 311 plus or minus 12 to 316 plus or minus 11 msec during spontaneous sinus rhythm; from 254 plus or minus 12 to 260 plus or minus 10 msec during atrial pacing) were not significant. However, in contrast to the Group I patients, the digoxin-induced changes in A-V nodal ERP (from 280 plus or minus 22 to 297 plus or minus 18 msec during atrial pacing) and FRP (from 368 plus or minus 18 to 377 plus or minus 18 msec during spontaneous sinus rhythm; from 334 plus or minus 13 to 346 plus or minus 16 msec during atrial pacing) were also statistically insignificant. Our results demonstrate that the electrophysiologic effects of digoxin on atrioventricular conduction in man are most marked in the atrioventricular node and are dependent on cardiac innervation

Adult↗
PubMed1975

Digoxin induced intestinal vasoconstriction. The effects of proximal arterial stenosis and glucagon administration.

Previous studies have been shown that intravenous cardiac glycosides produce mesenteric vasoconstriction (MVC). The possibility that this might critically compromise blood flow in patients with mesenteric vascular disease was suggested. To evaluate whether MVC occurs with intravenous cardiac glycosides in the presence of proximal mesenteric artery stenosis, blood flow in the superior mesenteric artery (SMA) of thirteen dogs was measured with a Doppler flowmeter. The SMA was constricted and pressures were measured in the aorta, SMA, and superior mesenteric vein. Superior mesenteric vascular resistance (SMVR) was calculated by dividing the pressure difference between the SMA and superior mesenteric vein by the total blood flow to the superior mesenteric vasculature and was reported as mm Hg/cc-min. Blood flow was measured simultaneously by a drop rate meter in the vein of a surgically isolated intestinal segment supplied by a single arterial arcade. Venous outflow pressure from this segment was also monitored, which allowed calculation of isolated gut segment resistance (IGSR) in mm Hg/cc-min per 100 g gut. Stenosis of the SMA produced pressure gradients of 10 to 75 mm Hg and decreased resting blood flow by as much as 82%. Digoxin produced an increase in both SMVR and IGSR throughout the 30 to 120 minute period of the study in thirteen dogs despite the presence of severe grades of SMA stenosis. There was no relationship between the degree of proximal SMA stenosis and the magnitude of resistance change due to digoxin. To determine if this MVC was reversible, glucagon was administered to eleven dogs 30 to 60 minutes after digoxin and completely overcame the constriction. Thus, digoxin produced MVC in the presence of proximal SMA stenosis. This MVC was pharmacologically reversible. These data suggest that intravenous digoxin might contribute to intestinal ischemia in patients with preexisting vascular disease.

Animals↗
PubMed1981

Acute vasodilator therapy increases renal clearance of digoxin in patients with congestive heart failure.

We studied the effect of vasodilator therapy on renal digoxin clearance in patients with chronic congestive heart failure. Intravenous administration of nitroprusside or hydralazine to eight patients with severe heart failure produced the expected increase in cardiac output and a decrease in central circulatory pressure. Renal clearance of sodium para-aminohippurate and estimated renal blood flow increased without a change in glomerular filtration rate. Total renal clearance of digoxin increased by 50% during vasodilator therapy. Thus, acute administration of vasodilator increases renal digoxin clearance without changing glomerular filtration rate, suggesting an increase in tubular secretion of digoxin. Long-term vasodilator therapy may alter the maintenance dosage of digoxin required for optimal treatment of patients in congestive heart failure.

Chronic Disease↗
PubMed1996

Digoxin reduces beta-adrenergic contractile response in rabbit hearts. Ca(2+)-dependent inhibition of adenylyl cyclase activity via Na+/Ca2+ exchange.

Whereas mobilization of intracellular Ca2+ stimulates neuronal adenylyl cyclase via Ca2+/calmodulin, mobilized Ca2+ directly inhibits adenylyl cyclase in other tissues. To determine the physiologic role of the Ca(2+)-dependent interaction between Na+/Ca2+ exchange and beta-adrenergic signal transduction in the intact heart, digoxin (0.3 mg/kg) was administered intravenously in rabbits. 30 min after the administration, digoxin impaired the peak left ventricular dP/dt response to dobutamine infusions by up to 38% as compared with control rabbits. This impairment was not caused by changes in either beta-adrenergic receptor number or in the functional activity of stimulatory guanine nucleotide-binding protein. It was associated with 33-36% reductions in basal and stimulated adenylyl cyclase activities. Animals treated with calcium gluconate (20 mg/kg/min for 30 min) also demonstrated similar reductions in adenylyl cyclase activities. In addition, increasing the free Ca2+ concentration progressively inhibited adenylyl cyclase activity in the control, digoxin-treated, and calcium gluconate-treated sarcolemma preparations in vitro. Moreover, digoxin and calcium gluconate pretreatment blunted the increase in cAMP in myocardial tissue after dobutamine infusion in vivo. Thus, digoxin rapidly reduces beta-adrenergic contractile response in rabbit hearts. This reduction may reflect an inhibition of adenylyl cyclase by Ca2+ mobilized via Na+/Ca2+ exchange.

4-Nitrophenylphosphatase↗
PubMed1992

Comparative effects of digoxin and xamoterol on arrhythmias in patients with mild to moderate heart failure.

The prognosis of heart failure patients is poor and as many as half of the deaths are sudden and thereby presumably attributable to arrhythmias. In the present study the effect of traditional therapy of mild heart failure with digoxin on arrhythmias was compared with the effect of xamoterol, a cardioselective beta 1 partial agonist, which has in addition beta-blocking properties at higher levels of sympathetic tone. Fifteen patients (NYHA class II-III) were included in the study. After a two-week baseline period they were randomized to digoxin or xamoterol for four weeks followed by a two-week washout and another four weeks of crossover therapy. Heart rate, blood pressure, and the number of complex ventricular premature beats remained essentially unchanged with digoxin. With xamoterol heart rate increased from 86 to 93 (ns) but was significantly higher during the night in comparison with digoxin. The number of ventricular premature beats decreased from 186 +/- 317 to 110 +/- 137 and increased to 130 +/- 175 after treatment. The number of runs decreased from 11 +/- 35 to 2.7 +/- 5 and increased to 5.6 +/- 9 after therapy. In conclusion, no significant effect of digoxin or xamoterol on ventricular arrhythmias was found. However, xamoterol showed a tendency to reduce simple and complex ventricular arrhythmias in patients with mild to moderate heart failure.

Adrenergic beta-Agonists↗
PubMed2004

Absence of a clinically relevant interaction between etanercept and digoxin.

Etanercept, a soluble recombinant human tumor necrosis factor receptor (TNFr), is effective and well tolerated in the treatment of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and psoriasis. The primary objective of this study was to investigate the potential pharmacokinetic and pharmacodynamic interaction between digoxin and etanercept at steady state. In a crossover, open-label, nonrandomized, 3-period study, 12 healthy male subjects received loading oral doses of digoxin 0.5 mg every 12 hours on day 1 and 0.25 mg every 12 hours on day 2, followed by a daily maintenance dose of 0.25 mg for a total of 27 days. Etanercept was administered as a twice-weekly 25-mg subcutaneous dose beginning on day 9 and continuing up to day 37 for a total of 9 doses. All ratios of maximum plasma concentration (C(max)) and area under the plasma concentration versus time curve (AUC) for pharmacokinetics of digoxin fell within the confidence interval of 0.8 to 1.25. Although not considered clinically relevant, the mean C(max) and AUC of etanercept were 4.2% and 12.5% lower, respectively, when etanercept was given with digoxin than when administered alone. There were no clinically relevant changes in the electrocardiogram (ECG) parameters, and adverse events did not increase when both drugs were combined. In conclusion, there is no clinically relevant interaction between etanercept and digoxin, and both drugs can be safely coadministered without the need for a dosage adjustment.

Adult↗
PubMed2005

Influence of coadministration on the pharmacokinetics of azimilide dihydrochloride and digoxin.

The influence of coadministration on digoxin and azimilide pharmacokinetics/pharmacodynamics was assessed in a randomized, 3-way crossover study in 18 healthy men. Serial blood and urine samples were obtained for azimilide and digoxin quantitation. Treatment effects on pharmacokinetics were assessed using analysis of variance. The relationship between azimilide blood concentrations and QT(c) prolongation was characterized by an E(max) model. Effects of coadministration on pharmacodynamics were assessed using a mechanistic-based inhibition model. Azimilide pharmacokinetics was unaffected by digoxin, except for a 36% increase in CL(r) (P = .0325), with no change in CL(o). Digoxin pharmacokinetics was unaffected by azimilide, except for a 21% increase in C(max) (P = .0176) and a 10% increase in AUC(tau) (P = .0121). Digoxin coadministration increased the apparent EC(50) with no effect on E(max), consistent with competitive inhibition (K(i) = 0.899 ng/mL). The pharmacokinetic and pharmacodynamic changes observed upon coadministration were small and are not expected to be clinically important.

Adolescent↗
PubMed2005

Effect of lasofoxifene on the pharmacokinetics of digoxin in healthy postmenopausal women.

Lasofoxifene is in late-stage development for the prevention and treatment of osteoporosis. Digoxin is commonly prescribed for arrhythmias and congestive heart failure, has a narrow therapeutic index, and may be coadministered with lasofoxifene. This study was conducted to determine the effect of lasofoxifene (4-mg loading dose on day 11 followed by 0.5 mg/d on days 12-20) on the steady-state pharmacokinetics of digoxin (0.25 mg/d on days 1-20) in 12 healthy postmenopausal women. On days 10 and 20, blood and urine samples were collected for 24 hours to determine digoxin concentrations. The 90% confidence interval (CI) of least squares mean ratio for maximum concentration (C(max)) and area under the plasma concentration-time curve (AUC) was calculated. Lasofoxifene had no effect on digoxin plasma pharmacokinetics with a ratio (90% CI) of 95.4% (84.6%-107%) and 103% (97.7%-108%) for C(max) and AUC(0-24), respectively. The ratio of the percentage of dose eliminated unchanged in urine in 24 hours was 127% (116% to 142%). Coadministration of lasofoxifene had no effect on the steady state pharmacokinetics of digoxin.

Aged↗
PubMed1999

Effect of multiple doses of montelukast, a CysLT1 receptor antagonist, on digoxin pharmacokinetics in healthy volunteers.

The effect of multiple oral doses of montelukast, a cysLT1 receptor antagonist, on the pharmacokinetics of oral digoxin was studied in healthy male volunteers in a randomized double-blind two-period crossover study. Subjects received 10 mg of montelukast or placebo daily for 11 days. On day 7, they received a single 0.5 mg oral dose of digoxin elixir. The pharmacokinetic parameters of digoxin (AUC0-->24' AUC0-->infinity' Cmax' tmax' t1/2) and cumulative urinary excretion over 120 hours were not affected by the multiple doses of montelukast. The 90% confidence interval for each of these parameters fell within prespecified clinically acceptable bounds. Side effects were mild and transient. This suggests that concurrent administration of montelukast and digoxin was well tolerated. Concurrent treatment with montelukast has no effect on the pharmacokinetics of digoxin.

Acetates↗
PubMedDate not supplied

A comparison of digoxin concentration--time curves before and after open-heart surgery.

The effects of open heart surgery on serum digoxin concentration--time curves were investigated in 10 cardiac patients receiving 0.25 mg/day digoxin. Blood samples were obtained from the patients immediately before and 1, 2, 3, 5, 8, 16 and 24 h after digoxin administration, both before open-heart surgery and 7 days after surgery. Serum digoxin concentrations, determined by fluorescence polarization immuno-assay, significantly (P < 0.05) increased after surgery, as did the maximum serum concentrations and the areas under the concentration-time curves. After surgery there was a significant increase in the serum gamma-glutamyl transferase concentration and a significant reduction in the total protein concentration. A reduction of digoxin dose may be appropriate for patients who have undergone open-heart surgery.

Adult↗
PubMed1996

Screening for clinical laboratory errors with Medicare claims data: results for digoxin.

A statistical model is demonstrated for finding outpatient clinical laboratories having high frequencies of bad patient outcomes, after testing, that may indicate testing errors. A sample of Medicare Part A and Part B claims for 30,685 digoxin tests for 1985 through 1987 was analyzed. Deaths or digoxin-related hospitalizations within 14 days of digoxin testing are defined as "adverse events" potentially influenced by test information. Approximately 3.3% of digoxin tests were followed by adverse events with two-thirds resulting in hospitalization or death. Adverse events were (a) lower in states with stronger laboratory regulations, (b) 15% higher whenever the site of testing switched, (c) unrelated to testing in low volume physician office laboratories, and (d) unrelated to frequency of digoxin testing in previous 6 months. Results a and b are consistent with findings for prothrombin testing but c and d are not. Differences are consistent with technical characteristics of the tests.

Anti-Arrhythmia Agents↗
PubMed1997

Digoxin toxicity in chronic renal failure: treatment by multiple dose activated charcoal intestinal dialysis.

1. Digoxin toxicity can result from overdose or iatrogenic causes, especially if renal function is impaired. 2. We present a case of digoxin toxicity presenting with severe bradycardia and hypotension in a 66 year old man with chronic renal failure. Regular haemodialysis had, as predicted, failed to reduce his plasma digoxin concentration. Digoxin specific antibody fragments (Fab) were not readily available and their use was probably inappropriate as they are normally renally eliminated. 3. The patient was successfully treated by two prolonged courses of intestinal dialysis with repeated doses of activated charcoal over 48 and 72 h and totaling 400 g and 600 g, respectively. However, the patient found the activated charcoal extremely unpalatable. 4. Multiple dose activated charcoal intestinal dialysis (MDACID) has been recently advocated for use in a wide range of poisonings. The technique takes advantage of the large surface area of the small intestine to eliminate drugs and metabolites, over several days if necessary. The pharmacokinetics of digoxin toxicity in chronic renal failure make intestinal dialysis an appropriate method of treatment but the realisation of the true potential of this technique awaits a more palatable absorbent or formulation.

Aged↗
PubMed1981

Use of colestipol in a patient with digoxin intoxication.

The steroid-binding drug colestipol was administered to a patient with digoxin intoxication and the serial digoxin levels were measured. The actual half-life of elimination of digoxin was 55 hours, whereas the predicted half-life calculated from standard pharmacokinetic equations was at least 85 hours. Colestipol presumably interrupts the enterohepatic recycling of digoxin and enhances its fecal excretion. This is the first documented report of the successful use of colestipol for digoxin intoxication.

Colestipol↗
PubMed1983

Perspectives on digoxin absorption from small bowel resections.

Digoxin is a commonly prescribed medication for a variety of cardiovascular abnormalities. The therapeutic index of digoxin is considered narrow and drug is absorbed predominantly from the duodenum and upper jejunum. When the small intestine is intact, the absorption can vary; therefore, in the case of a small bowel resection or bypass, this erratic absorption may be accentuated. There is some controversy concerning the effect of small bowel resection or bypass on the absorption of digoxin. Some investigators have shown that small bowel resection or bypass decreases the absorption of oral digoxin, whereas others report no change in absorption. When the study methodologies were evaluated, certain common factors that support each view were found. In most studies reporting malabsorption, a solid dosage form of digoxin was used. Studies reporting no change in absorption investigated a solution dosage form.

Biological Availability↗