Commentaries:
Obsertvationl study; need to be validate with prospective studies.
Amiodarone use after acute myocardial infarction complicated by heart failure and/or left ventricular dysfunction may be associated with excess mortality
American Heart Journal
Volume 155, Issue 1, Pages 87-93 (January 2008)
Kevin L. Thomas, MDa, Sana M. Al-Khatib, MHS, MDa, Yuliya Lokhnygina, PhDa, Scott D. Solomon, MDb, Lars Kober, MDc, John J.V. McMurray, MDd, Robert M. Califf, MDa, Eric J. Velazquez, MDa
Background
We sought to assess the association of amiodarone use with mortality during consecutive periods in patients with post–acute myocardial infarction with left ventricular systolic dysfunction and/or HF treated with a contemporary medical regimen.
Methods
This study used data from VALIANT, a randomized comparison of valsartan, captopril, or both in patients with acute myocardial infarction with HF and/or left ventricular systolic dysfunction. We compared baseline characteristics of 825 patients treated with amiodarone at randomization with 13 875 patients not treated with amiodarone. Using Cox models, we examined the association of amiodarone use with subsequent mortality during consecutive periods after randomization (days 1-16, 17-45, 46-198, and 199-1096).
Results
Patients treated with amiodarone were older, had higher Killip class, and were more likely to have a history of diabetes mellitus and hypertension. Adjusting for baseline predictors of mortality, we found that amiodarone use was associated with a significant increase in mortality during 3 of the 4 periods: hazard ratio 1.5, 95% CI (1.1-2.0), P = .02, for days 1 to 16; 2.1 (1.5-2.9), P < .001, for days 17 to 45; 1.1 (0.83-1.46), P = .51, for days 46 to 198; and 1.4 (1.2-1.6), P < .001, for days 199 to 1096. Conclusion
In this study, amiodarone use was associated with excess early and late all-cause and cardiovascular mortality. These observational findings are in contrast to earlier randomized trials of amiodarone and need to be validated prospectively.
Showing posts with label Amiodarone. Show all posts
Showing posts with label Amiodarone. Show all posts
Monday, January 21, 2008
Saturday, January 19, 2008
Prescribing Amiodarone - An Evidence-Based Review of Clinical Indications
Prescribing Amiodarone
An Evidence-Based Review of Clinical Indications
Patricia Vassallo, MD; Richard G. Trohman, MD
JAMA. 2007;298:1312-1322.
Context Although amiodarone is approved by the US Food and Drug Administration only for refractory ventricular arrhythmias, it is one of the most frequently prescribed antiarrhythmic medications in the United States.
Objective To evaluate and synthesize evidence regarding optimal use of amiodarone for various arrhythmias.
Evidence Acquisition Systematic search of MEDLINE to identify peer-reviewed clinical trials, randomized controlled trials, meta-analyses, and other studies with clinical pertinence. The search was limited to human-participant, English-language reports published between 1970 and 2007. Amiodarone was searched using the terms adverse effects, atrial fibrillation, atrial flutter, congestive heart failure, electrical storm, hypertrophic cardiomyopathy, implantable cardioverter-defibrillator, surgery, ventricular arrhythmia, ventricular fibrillation, and Wolff-Parkinson-White. Bibliographies of identified articles and guidelines from official societies were reviewed for additional references. Ninety-two identified studies met inclusion criteria and were included in the review.
Evidence Synthesis Amiodarone may have clinical value in patients with left ventricular dysfunction and heart failure as first-line treatment for atrial fibrillation, though other agents are available. Amiodarone is useful in acute management of sustained ventricular tachyarrythmias, regardless of hemodynamic stability. The only role for prophylactic amiodarone is in the perioperative period of cardiac surgery. Amiodarone may be effective as an adjunct to implantable cardioverter-defibrillator therapy to reduce number of shocks. However, amiodarone has a number of serious adverse effects, including corneal microdeposits (>90%), optic neuropathy/neuritis (1%-2%), blue-gray skin discoloration (4%-9%), photosensitivity (25%-75%), hypothyroidism (6%), hyperthyroidism (0.9%-2%), pulmonary toxicity (1%-17%), peripheral neuropathy (0.3% annually), and hepatotoxicity (elevated enzyme levels, 15%-30%; hepatitis and cirrhosis, <3%>
Conclusion Amiodarone should be used with close follow-up in patients who are likely to derive the most benefit, namely those with atrial fibrillation and left ventricular dysfunction, those with acute sustained ventricular arrhythmias, those about to undergo cardiac surgery, and those with implantable cardioverter-defibrillators and symptomatic shocks.
An Evidence-Based Review of Clinical Indications
Patricia Vassallo, MD; Richard G. Trohman, MD
JAMA. 2007;298:1312-1322.
Context Although amiodarone is approved by the US Food and Drug Administration only for refractory ventricular arrhythmias, it is one of the most frequently prescribed antiarrhythmic medications in the United States.
Objective To evaluate and synthesize evidence regarding optimal use of amiodarone for various arrhythmias.
Evidence Acquisition Systematic search of MEDLINE to identify peer-reviewed clinical trials, randomized controlled trials, meta-analyses, and other studies with clinical pertinence. The search was limited to human-participant, English-language reports published between 1970 and 2007. Amiodarone was searched using the terms adverse effects, atrial fibrillation, atrial flutter, congestive heart failure, electrical storm, hypertrophic cardiomyopathy, implantable cardioverter-defibrillator, surgery, ventricular arrhythmia, ventricular fibrillation, and Wolff-Parkinson-White. Bibliographies of identified articles and guidelines from official societies were reviewed for additional references. Ninety-two identified studies met inclusion criteria and were included in the review.
Evidence Synthesis Amiodarone may have clinical value in patients with left ventricular dysfunction and heart failure as first-line treatment for atrial fibrillation, though other agents are available. Amiodarone is useful in acute management of sustained ventricular tachyarrythmias, regardless of hemodynamic stability. The only role for prophylactic amiodarone is in the perioperative period of cardiac surgery. Amiodarone may be effective as an adjunct to implantable cardioverter-defibrillator therapy to reduce number of shocks. However, amiodarone has a number of serious adverse effects, including corneal microdeposits (>90%), optic neuropathy/neuritis (1%-2%), blue-gray skin discoloration (4%-9%), photosensitivity (25%-75%), hypothyroidism (6%), hyperthyroidism (0.9%-2%), pulmonary toxicity (1%-17%), peripheral neuropathy (0.3% annually), and hepatotoxicity (elevated enzyme levels, 15%-30%; hepatitis and cirrhosis, <3%>
Conclusion Amiodarone should be used with close follow-up in patients who are likely to derive the most benefit, namely those with atrial fibrillation and left ventricular dysfunction, those with acute sustained ventricular arrhythmias, those about to undergo cardiac surgery, and those with implantable cardioverter-defibrillators and symptomatic shocks.
Wednesday, October 17, 2007
Amiodarone raises hypothyroidism in older atrial fibrillation patients
Amiodarone raises hypothyroidism in older atrial fibrillation patients
By Liam Davenport
16 October 2007
Am J Med 2007; 120: 880-885
MedWire News: Older males treated with amiodarone for persistent atrial fibrillation are substantially more likely to develop hypothyroidism than patients with atrial fibrillation who not given the treatment, US study findings indicate.
The majority of patients who are given amiodarone, which has recently been found to have unparalled effectiveness in maintaining sinus rhythm, are male, say Elizabeth Batcher, from West Los Angeles Veterans Affairs Medical Center in California, and colleagues. However, the long-term risk of amiodarone-induced thyroid dysfunction has not been thoroughly investigated.
The team therefore performed a substudy of 612 patients from the Sotalol Amiodarone Atrial Fibrillation Efficacy Trial, of whom 247 were treated with amiodarone and 365 were given sotalol or placebo. Sotalol and placebo patients were combined to form a control group, as neither would be expected to alter thyroid function, the authors note. The average age of the groups was 67.1 years for amiodarone-treated patients and 66.9 years among controls.
Thyroid function was measured at baseline, 3 month, 6 months, and every 6 months for up to 4.5 years by measuring serum thyroid-stimulating hormone (TSH) concentrations. There were no statistical differences in TSH levels at baseline between the groups.
The results indicate that subclinical hypothyroidism, defined as a TSH level of 4.5-10 mU/l, occurred in 25.8% of patients treated with amiodarone, compared with 6.6% of those from the control group, the team reports in the American Journal of Medicine.
In addition, 5.0% of amiodarone patients were found to have overt hypothyroidism, defined as a TSH level of over 10 mU/l, compared with just 0.3% of controls. In both cases, the difference between the amiodarone and control groups was significant.
Of the patients who developed TSH levels of more than 10 mU/l, 93.8% were detected by 6 months. It was also observed that amiodarone patients had a trend towards a greater prevalence of hyperthyroidism, defined as a TSH level of less than 0.35 mU/l, than controls, at 5.3% versus 2.4%.
The researchers write: "In summary, amiodarone-induced hypothyroidism developed in 30.8% of older men treated with amiodarone for chronic atrial fibrillation compared with the control group and presented early during therapy."
They add: "Given the high rate of hypothyroidism among patients taking amiodarone, monitoring of thyroid function is recommended at baseline, 3 months, and every 6 months thereafter during the therapy."
Free abstract
By Liam Davenport
16 October 2007
Am J Med 2007; 120: 880-885
MedWire News: Older males treated with amiodarone for persistent atrial fibrillation are substantially more likely to develop hypothyroidism than patients with atrial fibrillation who not given the treatment, US study findings indicate.
The majority of patients who are given amiodarone, which has recently been found to have unparalled effectiveness in maintaining sinus rhythm, are male, say Elizabeth Batcher, from West Los Angeles Veterans Affairs Medical Center in California, and colleagues. However, the long-term risk of amiodarone-induced thyroid dysfunction has not been thoroughly investigated.
The team therefore performed a substudy of 612 patients from the Sotalol Amiodarone Atrial Fibrillation Efficacy Trial, of whom 247 were treated with amiodarone and 365 were given sotalol or placebo. Sotalol and placebo patients were combined to form a control group, as neither would be expected to alter thyroid function, the authors note. The average age of the groups was 67.1 years for amiodarone-treated patients and 66.9 years among controls.
Thyroid function was measured at baseline, 3 month, 6 months, and every 6 months for up to 4.5 years by measuring serum thyroid-stimulating hormone (TSH) concentrations. There were no statistical differences in TSH levels at baseline between the groups.
The results indicate that subclinical hypothyroidism, defined as a TSH level of 4.5-10 mU/l, occurred in 25.8% of patients treated with amiodarone, compared with 6.6% of those from the control group, the team reports in the American Journal of Medicine.
In addition, 5.0% of amiodarone patients were found to have overt hypothyroidism, defined as a TSH level of over 10 mU/l, compared with just 0.3% of controls. In both cases, the difference between the amiodarone and control groups was significant.
Of the patients who developed TSH levels of more than 10 mU/l, 93.8% were detected by 6 months. It was also observed that amiodarone patients had a trend towards a greater prevalence of hyperthyroidism, defined as a TSH level of less than 0.35 mU/l, than controls, at 5.3% versus 2.4%.
The researchers write: "In summary, amiodarone-induced hypothyroidism developed in 30.8% of older men treated with amiodarone for chronic atrial fibrillation compared with the control group and presented early during therapy."
They add: "Given the high rate of hypothyroidism among patients taking amiodarone, monitoring of thyroid function is recommended at baseline, 3 months, and every 6 months thereafter during the therapy."
Free abstract
Tuesday, September 18, 2007
Prescribing Amiodarone
Prescribing Amiodarone
An Evidence-Based Review of Clinical Indications
Patricia Vassallo, MD; Richard G. Trohman, MD
JAMA. 2007;298:1312-1322.
Context Although amiodarone is approved by the US Food and Drug Administration only for refractory ventricular arrhythmias, it is one of the most frequently prescribed antiarrhythmic medications in the United States.
Objective To evaluate and synthesize evidence regarding optimal use of amiodarone for various arrhythmias.
Evidence Acquisition Systematic search of MEDLINE to identify peer-reviewed clinical trials, randomized controlled trials, meta-analyses, and other studies with clinical pertinence. The search was limited to human-participant, English-language reports published between 1970 and 2007. Amiodarone was searched using the terms adverse effects, atrial fibrillation, atrial flutter, congestive heart failure, electrical storm, hypertrophic cardiomyopathy, implantable cardioverter-defibrillator, surgery, ventricular arrhythmia, ventricular fibrillation, and Wolff-Parkinson-White. Bibliographies of identified articles and guidelines from official societies were reviewed for additional references. Ninety-two identified studies met inclusion criteria and were included in the review.
Evidence Synthesis Amiodarone may have clinical value in patients with left ventricular dysfunction and heart failure as first-line treatment for atrial fibrillation, though other agents are available. Amiodarone is useful in acute management of sustained ventricular tachyarrythmias, regardless of hemodynamic stability. The only role for prophylactic amiodarone is in the perioperative period of cardiac surgery. Amiodarone may be effective as an adjunct to implantable cardioverter-defibrillator therapy to reduce number of shocks. However, amiodarone has a number of serious adverse effects, including corneal microdeposits (>90%), optic neuropathy/neuritis (1%-2%), blue-gray skin discoloration (4%-9%), photosensitivity (25%-75%), hypothyroidism (6%), hyperthyroidism (0.9%-2%), pulmonary toxicity (1%-17%), peripheral neuropathy (0.3% annually), and hepatotoxicity (elevated enzyme levels, 15%-30%; hepatitis and cirrhosis, <3% [0.6% annually]).
Conclusion Amiodarone should be used with close follow-up in patients who are likely to derive the most benefit, namely those with atrial fibrillation and left ventricular dysfunction, those with acute sustained ventricular arrhythmias, those about to undergo cardiac surgery, and those with implantable cardioverter-defibrillators and symptomatic shocks.
Author Affiliations: Department of Medicine, Section of Cardiology, Electrophysiology, Arrhythmia, and Pacemaker Service, Rush University Medical Center, Chicago, Illinois.
An Evidence-Based Review of Clinical Indications
Patricia Vassallo, MD; Richard G. Trohman, MD
JAMA. 2007;298:1312-1322.
Context Although amiodarone is approved by the US Food and Drug Administration only for refractory ventricular arrhythmias, it is one of the most frequently prescribed antiarrhythmic medications in the United States.
Objective To evaluate and synthesize evidence regarding optimal use of amiodarone for various arrhythmias.
Evidence Acquisition Systematic search of MEDLINE to identify peer-reviewed clinical trials, randomized controlled trials, meta-analyses, and other studies with clinical pertinence. The search was limited to human-participant, English-language reports published between 1970 and 2007. Amiodarone was searched using the terms adverse effects, atrial fibrillation, atrial flutter, congestive heart failure, electrical storm, hypertrophic cardiomyopathy, implantable cardioverter-defibrillator, surgery, ventricular arrhythmia, ventricular fibrillation, and Wolff-Parkinson-White. Bibliographies of identified articles and guidelines from official societies were reviewed for additional references. Ninety-two identified studies met inclusion criteria and were included in the review.
Evidence Synthesis Amiodarone may have clinical value in patients with left ventricular dysfunction and heart failure as first-line treatment for atrial fibrillation, though other agents are available. Amiodarone is useful in acute management of sustained ventricular tachyarrythmias, regardless of hemodynamic stability. The only role for prophylactic amiodarone is in the perioperative period of cardiac surgery. Amiodarone may be effective as an adjunct to implantable cardioverter-defibrillator therapy to reduce number of shocks. However, amiodarone has a number of serious adverse effects, including corneal microdeposits (>90%), optic neuropathy/neuritis (1%-2%), blue-gray skin discoloration (4%-9%), photosensitivity (25%-75%), hypothyroidism (6%), hyperthyroidism (0.9%-2%), pulmonary toxicity (1%-17%), peripheral neuropathy (0.3% annually), and hepatotoxicity (elevated enzyme levels, 15%-30%; hepatitis and cirrhosis, <3% [0.6% annually]).
Conclusion Amiodarone should be used with close follow-up in patients who are likely to derive the most benefit, namely those with atrial fibrillation and left ventricular dysfunction, those with acute sustained ventricular arrhythmias, those about to undergo cardiac surgery, and those with implantable cardioverter-defibrillators and symptomatic shocks.
Author Affiliations: Department of Medicine, Section of Cardiology, Electrophysiology, Arrhythmia, and Pacemaker Service, Rush University Medical Center, Chicago, Illinois.
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