Journal article
Lack of a hypotensive effect with rapid administration of a new aqueous formulation of intravenous amiodarone
The American journal of cardiology, Vol.93(5), pp.576-581
2004
DOI: 10.1016/j.amjcard.2003.11.021
PMID: 14996582
Abstract
Hypotension is the most frequent adverse event reported with intravenous amiodarone. Hypotension has been attributed to the vasoactive solvents of the standard formulation (Cordarone IV) and is not dose related, but related to the rate of infusion. Drug labeling calls for intravenous amiodarone to be administered over 10 minutes. A new aqueous formulation of amiodarone (Amio-Aqueous) does not contain vasoactive excipients and may be administered safely by rapid administration without hypotension. This hypothesis was tested using combined data of 4 clinical trials; each assessed the development of hypotension prospectively. Hypotension was defined as a 25% decrease in systolic blood pressure (BP), with the development of a systolic BP of <90 mm Hg or a systolic BP that decreased to <80 mm Hg. In all, 358 Amio-Aqueous and 225 lidocaine boluses were administered to 278 patients; 246 had ventricular tachycardia (VT) during drug administration. Hypotension developed in 11% of patients on Amio-Aqueous versus 19% on lidocaine (p = NS), all during VT; most resolved spontaneously with VT termination. With both drugs, hypotension persisted after VT termination in 1% of patients; the incidence of drug-related hypotension occurred in 2% of patients (1% had hypotension requiring treatment). The Amio-Aqueous was discontinued in 1% of patients, and lidocaine was discontinued in 2% of patients because of hypotension. We conclude that Amio-Aqueous is at least as safe as lidocaine in terms of causing hypotension when administered rapidly. This is a significant advantage over the standard amiodarone formulation, because Cordarone cannot be administered by rapid bolus owing to excipient-related hypotension.
Details
- Title: Subtitle
- Lack of a hypotensive effect with rapid administration of a new aqueous formulation of intravenous amiodarone
- Creators
- John C. Somberg - Rush UniversitySandor Timar - County Hospital of Bacs-Kiskun, Kecskemet, HungarySteven J. Bailin - Mercy Medical CenterFerenc Lakatos - Rethy Pal Hospital, Bekescsaba, HungaryCharles I. Haffajee - St. Elizabeth's Medical CenterJeno Tarjan - Markusovszky Egyetemi OktatókórházWalter P. Paladino - St. Elizabeth Youngstown HospitalIstvan Sarosi - University of PecsNicholas Z. Kerin - Botsford HospitalJozsef Borbola - National Institute of Cardiology, Budapest, HungaryDuane E. Bridges - Breakthru Clinical Trials, Inglewood, California, USAJanos Molnar - Academic Pharmaceuticals, Lake Bluff, Illlinois, USAAmio-Aqueous Investigators
- Resource Type
- Journal article
- Publication Details
- The American journal of cardiology, Vol.93(5), pp.576-581
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.amjcard.2003.11.021
- PMID
- 14996582
- ISSN
- 0002-9149
- eISSN
- 1879-1913
- Language
- English
- Date published
- 2004
- Academic Unit
- Cardiovascular Medicine; Internal Medicine
- Record Identifier
- 9984359940002771
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