Abstract | BACKGROUND: METHODS AND RESULTS: A total of 633 ICD recipients were enrolled in a randomized, double-blind, placebo-controlled study to evaluate the effect of daily doses of 75 or 125 mg of azimilide on recurrent symptomatic ventricular tachyarrhythmias and ICD therapies. Total all-cause shocks plus symptomatic ventricular tachycardia (VT) terminated by antitachycardia pacing ( ATP) were significantly reduced by azimilide, with relative risk reductions of 57% (hazard ratio [HR]=0.43, 95% CI 0.26 to 0.69, P=0.0006) and 47% (HR=0.53, 95% CI 0.34 to 0.83, P=0.0053) at 75- and 125-mg doses, respectively. The reductions in all-cause shocks with both doses of azimilide did not achieve statistical significance. The incidence of all appropriate ICD therapies (shocks or ATP-terminated VT) was reduced significantly among patients taking 75 mg of azimilide (HR=0.52, 95% CI 0.30 to 0.89, P=0.017) and those taking 125 mg of azimilide (HR=0.38, 95% CI 0.22 to 0.65, P=0.0004). Five patients in the azimilide groups and 1 patient in the placebo group had torsade de pointes; all were successfully treated by the device. One patient taking 75 mg of azimilide had severe but reversible neutropenia. CONCLUSIONS:
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Authors | Paul Dorian, Martin Borggrefe, Hussein R Al-Khalidi, Stefan H Hohnloser, Jose M Brum, Daljit S Tatla, Johannes Brachmann, Robert J Myerburg, David S Cannom, Michael van der Laan, Michael J Holroyde, Igor Singer, Craig M Pratt, SHock Inhibition Evaluation with azimiLiDe (SHIELD) Investigators |
Journal | Circulation
(Circulation)
Vol. 110
Issue 24
Pg. 3646-54
(Dec 14 2004)
ISSN: 1524-4539 [Electronic] United States |
PMID | 15533855
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Arrhythmia Agents
- Hydantoins
- Imidazolidines
- Piperazines
- azimilide
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Topics |
- Anti-Arrhythmia Agents
(adverse effects, therapeutic use)
- Defibrillators, Implantable
- Double-Blind Method
- Electric Countershock
- Endpoint Determination
- Female
- Humans
- Hydantoins
- Imidazolidines
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Piperazines
(adverse effects, therapeutic use)
- Secondary Prevention
- Tachycardia, Ventricular
(prevention & control, therapy)
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