Clinical efficacy and safety of intravenous amiodarone in infants and children

Figa, Felicia H.; Gow, Robert M.; Hamilton, Robert M.; Freedom, Robert M.

doi:10.1016/0002-9149(94)90746-3

Cited by 120 publications

(47 citation statements)

References 24 publications

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“…In recurrent or refractory SVT, both intravenous amiodarone and procainamide have been administered, with variable success rates reported in the literature. [1][2][3][4][5][6][7][8] No studies to date, however, have compared these 2 medications in terms of efficacy and safety in the treatment of pediatric patients with SVT. The purpose of this study was to (1) compare the treatment efficacy of amiodarone versus procainamide in pediatric patients with recurrent SVT and (2) compare the adverse effects associated with the use of these 2 medications.…”

Section: Editorial See Page 115 Clinical Perspective On P 140mentioning

confidence: 99%

Amiodarone Versus Procainamide for the Acute Treatment of Recurrent Supraventricular Tachycardia in Pediatric Patients

Chang

Silka

Moromisato

et al. 2010

Circ: Arrhythmia and Electrophysiology

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Background-Intravenous amiodarone and procainamide are both used as therapies for refractory supraventricular tachycardia (SVT). However, no studies have compared the efficacy and safety of these agents in pediatric patients. Methods and Results-All patients treated with intravenous amiodarone or procainamide during 25 consecutive months for the following mechanisms of SVT were included: orthodromic reciprocating tachycardia, intra-atrial reentrant tachycardia, and ectopic atrial tachycardia; junctional ectopic tachycardia was excluded. Treatment response was categorized as full success, partial success, or failure. Partial success was defined as clinical improvement and/or arrhythmia control but not meeting full success criteria. Adverse events were classified as major (requiring resuscitation) or minor (management changes). There were 40 episodes of SVT in 37 patients (median age, 34 days; 24 with congenital heart disease). Amiodarone was the initial therapy in 26 cases and procainamide in 14 cases. If partial and full success are combined, procainamide was successful in 71% of cases compared with 34% for amiodarone (Pϭ0.046). If partial success is considered a treatment failure, procainamide was successful in 50% compared with 15% for amiodarone (Pϭ0.029). Ten patients received the second medication after the first failed. Success was achieved in 5 of 8 amiodarone-to-procainamide crossovers compared with 1 of 2 procainamide-to-amiodarone crossovers. One major and 10 minor adverse events occurred in amiodarone patients versus 6 minor adverse events in procainamide patients (PϭNS). Conclusions-In this cohort, procainamide achieved greater success compared with amiodarone in the management of recurrent SVT without statistically significant differences in adverse event frequency. (Circ Arrhythm Electrophysiol.

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Section: Editorial See Page 115 Clinical Perspective On P 140mentioning

confidence: 99%

Amiodarone Versus Procainamide for the Acute Treatment of Recurrent Supraventricular Tachycardia in Pediatric Patients

Chang

Silka

Moromisato

et al. 2010

Circ: Arrhythmia and Electrophysiology

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“…[1][2][3][4][5][6][7][8][9][10][11][12][13][14] The available data in the literature for children, from a total of Ϸ65 patients, suggest that the drug is reasonably safe and effective for a variety of VAs and SVAs, including postoperative junctional ectopic tachycardia (JET). 1,[7][8][9] However, all prior studies have been unblinded and uncontrolled, leaving the possibility of bias. Furthermore, despite the fact that the commercially available preparation of IV amiodarone (Cordarone, Wyeth Pharmaceuticals) is known to cause significant hypotension in animals 15 and adult humans, 4 most of the studies in children have reported minimal hypotensive side effects.…”

mentioning

confidence: 99%

“…Furthermore, despite the fact that the commercially available preparation of IV amiodarone (Cordarone, Wyeth Pharmaceuticals) is known to cause significant hypotension in animals 15 and adult humans, 4 most of the studies in children have reported minimal hypotensive side effects. 1,[5][6][7][8][9] Consequently, this study was designed to address the efficacy and safety of amiodarone IV in a clinical trial. Because the available uncontrolled reports on amiodarone IV have noted far greater benefit than risk, investigators believed it was unethical to include a placebo in the trial.…”

mentioning

confidence: 99%

Intravenous Amiodarone for Incessant Tachyarrhythmias in Children

et al. 2005

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Background-Intravenous (IV) amiodarone has proven efficacy in adults. However, its use in children is based on limited retrospective data. Methods and Results-A double-blind, randomized, multicenter, dose-response study of the safety and efficacy of IV amiodarone was conducted in 61 children (30 days to 14.9 years; median, 1.6 years). Children with incessant tachyarrhythmias (supraventricular arrhythmias [nϭ26], junctional ectopic tachycardia [JET, nϭ31], or ventricular arrhythmias [nϭ4]) were randomized to 1 of 3 dosing regimens (low, medium, or high: load plus 47-hour maintenance) with up to 5 open-label rescue doses. The primary efficacy end point was time to success. Of 229 patients screened, 61 were enrolled during 13 months by 27 of 48 centers in 7 countries. Median time to success was significantly related to dose (28.2, 2.6, and 2.1 hours for the low-, medium-, and high-dose groups, respectively; Pϭ0.028). There was no significant association with dose for any arrhythmia subgroup, including JET, but the subgroups were too small for an accurate assessment. Adverse events (AEs) were common (87%), leading to withdrawal of 10 patients. There were 5 deaths in the 30-day follow-up period (2 possibly related to the study drug). Dose-related AEs included hypotension (36%), vomiting (20%), bradycardia (20%), atrioventricular block (15%) and nausea (10%). Conclusions-In children, the overall efficacy of IV amiodarone, as measured by time to success, was dose related but not significantly for any arrhythmia subgroup. AEs were common and appeared to be dose related. Although efficacious for critically ill patients, the dose-related risks of IV amiodarone should be taken into account when treating children with incessant arrhythmias. Prospective, placebo-controlled trials would be helpful in assessing antiarrhythmic drug efficacy in children, because their results may differ from retrospective series and adult studies.

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“…78,[81][82][83][84][85][86][87][88][89][90][91] Both procainamide and amiodarone have vasodilatory effects and negative inotropic properties, which can destabilize hemodynamic status. 87,92,93 These effects seem to depend on the dose given and the rate of administration.…”

Section: Adenosinementioning

confidence: 99%

“…33 Twelve studies have evaluated amiodarone for the treatment of hemodynamically unstable VT and VF. 78,[81][82][83][84][85][86][87][88][89][90][91] Although amiodarone has not been specifically evaluated for the pharmacological termination of hemodynamically stable VT, by extrapolation from other studies amiodarone remains acceptable (see the Stable Ventricular Tachycardia Algorithm), and for monomorphic VT with impaired cardiac function, amiodarone is the agent of first choice.…”

Section: Hemodynamically Stable (Monomorphic) Vt (See Algorithm)mentioning

confidence: 99%

Part 6: Advanced Cardiovascular Life Support : Section 5: Pharmacology I: Agents for Arrhythmias

2000

Circulation

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Clinical efficacy and safety of intravenous amiodarone in infants and children

Cited by 120 publications

References 24 publications

Amiodarone Versus Procainamide for the Acute Treatment of Recurrent Supraventricular Tachycardia in Pediatric Patients

Amiodarone Versus Procainamide for the Acute Treatment of Recurrent Supraventricular Tachycardia in Pediatric Patients

Intravenous Amiodarone for Incessant Tachyarrhythmias in Children

Part 6: Advanced Cardiovascular Life Support : Section 5: Pharmacology I: Agents for Arrhythmias

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