A randomized hemodynamic comparison of intravenous amiodarone with and without Tween 80

Muñoz, Aurelio Arnedillo; Karila, Paul; Gallay, P; Zettelmeier, F.; Messner, P; Mery, Marissa; Grolleau, R

doi:10.1093/oxfordjournals.eurheartj.a062467

Cited by 57 publications

(34 citation statements)

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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.…”

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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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confidence: 99%

Intravenous Amiodarone for Incessant Tachyarrhythmias in Children

et al. 2005

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“…In addition, polysorbate 80 has been shown to facilitate the transportation of several ions (K + , Na + , NH4 + , Ca ++ ) and inorganic molecules through membrane models [16][17][18][19] . Evidence exists that polysorbates may also modulate sensitivity to certain antitumor agents, increasing the transportation of those agents through the membrane or facilitating their interaction 6,19 , considering that amiodarone is a highly lipophilic drug 25 25 25 25 25 50 50 50 50 50 75 75 75 75 75 100 100 100 100 100 with endothelium with endothelium with endothelium with endothelium with endothelium without endothelium without endothelium without endothelium without endothelium without endothelium -10 -10 -10 -10 -10 -9 -9 -9 -9 -9 -8 with endothelium with endothelium with endothelium with endothelium with endothelium without endothelium without endothelium without endothelium without endothelium without endothelium -10 -10 -10 -10 -10 -9 -9 -9 -9 -9 -8 In vivo studies have also suggested that polysorbates are not inert and may influence the systemic effects of amiodarone 7,8,21 , although other authors have shown that polysorbate may damage the vascular endothelium at concentrations greater than those used in our study 4,5,10,11 . The exact mechanism by which amiodarone causes the release of relaxing endothelial factors has not been completely clarified, but amiodarone 22 and N-desethylamiodarone 23 have been shown to promote a sustained increase in the concentrations of cytoplasmic calcium in endothelial cells.…”

Section: Discussionmentioning

confidence: 99%

“…In addition to the intrinsic effects of amiodarone, polysorbate 80, a solvent used in commercial amiodarone, may influence the effect of other drugs [6][7][8] , cause histamine release 9 , and be potentially harmful to the endothelium 10,11 . These effects may be clinically relevant, and have led to the search for other aqueous presentations of amiodarone 12 .…”

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confidence: 99%

Amiodarona causa vasodilatação dependente do endotélio em artérias coronárias caninas

Rodrigues

Évora

Maruo

et al. 2005

Arq. Bras. Cardiol.

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ObjectiveTo assess the vasodilating effects of amiodarone on canine coronary arteries by using solutions of amiodarone dissolved in polysorbate 80 or water. MethodsRings of coronary arteries, with or without intact endothelium, were immersed in Krebs solution and connected to a transducer for measuring the isometric force promoted by a vascular contraction. The arteries were exposed to increasing concentrations of polysorbate 80, amiodarone dissolved in water, amiodarone dissolved in polysorbate 80, and a commercial presentation of amiodarone (Cordarone). The experiments were conducted in the presence of the following enzymatic blockers: only indomethacin, Nω-nitro-L-arginine associated with indomethacin, and only Nω-nitro-L-arginine. ResultsPolysorbate 80 caused a small degree of nonendotheliumdependent relaxation. Cordarone, amiodarone dissolved in water, and amiodarone dissolved in polysorbate 80 caused endotheliumdependent relaxation, which was greater for amiodarone dissolved in polysorbate and for Cordarone. Only the association of indomethacin and Nω-nitro-L-arginine could eliminate the endothelium-dependent relaxation caused by amiodarone dissolved in polysorbate 80. ConclusionThe results obtained indicate that vasodilation promoted by amiodarone in canine coronary arteries is mainly caused by stimulation of the release of nitric oxide and cyclooxygenase-dependent relaxing endothelial factors.

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“…Bradycardia caused by iv infusion of this antiarrhythmic drug has also been observed in humans (17) and rats (9). The negative chronotropic effect induced by amiodarone has been attributed to its depressant effect on the sinus node involving blockade of Ca 2+ L-type channels (18,19), prolongation of the action potential and/or reduction of the slope of the diastolic depolarization (20).…”

Section: Hemodynamic Effects Of Amiodaronementioning

confidence: 99%

Acute effect of amiodarone on cardiovascular reflexes of normotensive and renal hypertensive rats

Oliveira

Silva

Salgado

et al. 2005

Braz J Med Biol Res

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The aim of the present study was to evaluate the effect of amiodarone on mean arterial pressure (MAP), heart rate (HR), baroreflex, BezoldJarisch, and peripheral chemoreflex in normotensive and chronic onekidney, one-clip (1K1C) hypertensive rats (N = 9 to 11 rats in each group). Amiodarone (50 mg/kg, iv) elicited hypotension and bradycardia in normotensive (-10 ± 1 mmHg, -57 ± 6 bpm) and hypertensive rats (-37 ± 7 mmHg, -39 ± 19 bpm). The baroreflex index (∆HR/ ∆MAP) was significantly attenuated by amiodarone in both normotensive (-0.61 ± 0.12 vs -1.47 ± 0.14 bpm/mmHg for reflex bradycardia and -1.15 ± 0.19 vs -2.63 ± 0.26 bpm/mmHg for reflex tachycardia) and hypertensive rats (-0.26 ± 0.05 vs -0.72 ± 0.16 bpm/mmHg for reflex bradycardia and -0.92 ± 0.19 vs -1.51 ± 0.19 bpm/mmHg for reflex tachycardia). The slope of linear regression from ∆pulse interval/∆MAP was attenuated for both reflex bradycardia and tachycardia in normotensive rats (-0.47 ± 0.13 vs -0.94 ± 0.19 ms/mmHg and -0.80 ± 0.13 vs -1.11 ± 0.13 ms/mmHg), but only for reflex bradycardia in hypertensive rats (-0.15 ± 0.02 vs -0.23 ± 0.3 ms/mmHg). In addition, the MAP and HR responses to the Bezold-Jarisch reflex were 20-30% smaller in amiodarone-treated normotensive or hypertensive rats. The bradycardic response to peripheral chemoreflex activation with intravenous potassium cyanide was also attenuated by amiodarone in both normotensive (-30 ± 6 vs -49 ± 8 bpm) and hypertensive rats (-34 ± 13 vs -42 ± 10 bpm). On the basis of the well-known electrophysiological effects of amiodarone, the sinus node might be the responsible for the attenuation of the cardiovascular reflexes found in the present study.

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A randomized hemodynamic comparison of intravenous amiodarone with and without Tween 80

Cited by 57 publications

References 0 publications

Intravenous Amiodarone for Incessant Tachyarrhythmias in Children

Intravenous Amiodarone for Incessant Tachyarrhythmias in Children

Amiodarona causa vasodilatação dependente do endotélio em artérias coronárias caninas

Acute effect of amiodarone on cardiovascular reflexes of normotensive and renal hypertensive rats

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