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CLINICAL RESEARCH: ELECTROPHYSIOLOGY

Azimilide decreases recurrent ventricular tachyarrhythmias in patients with implantable cardioverter defibrillators

Igor Singer, MD, FACC^*,*, Hussein Al-Khalidi, PhD, Imran Niazi, MD, FACC, Patrick Tchou, MD, FACC, Tony Simmons, MD, FACC^||, Richard Henthorn, MD, FACC^¶, Michael Holroyde, PhD and Jose Brum, MD

^* University of Louisville, Division of Cardiology, Louisville, Kentucky, USA
Health Care Research Center, Procter & Gamble Pharmaceuticals, Inc., Cincinnati, Ohio, USA
Arrhythmia Center, Milwaukee, Wisconsin, USA
Cleveland Clinic Foundation, Cardiology Department, Cleveland, Ohio, USA
^|| Bowman Gray School of Medicine, Department of Cardiology, Winston Salem, North Carolina, USA
^¶ University of Cincinnati Hospital, Cincinnati, Ohio, USA

^* Reprint requests and correspondence: Dr. Igor Singer, Cardiovascular Services, Methodist Medical Center, 221 N. E. Glen Oak Avenue, Atrium Building, Suite 470, Peoria, Illinois 61636-0002, USA.
isinger{at}mmci.org

OBJECTIVES: This study evaluated the effects of azimilide dihydrochloride (AZ) on anti-tachycardia pacing (ATP) and shock-terminated events in patients with implantable cardioverter defibrillators (ICDs).

BACKGROUND: Animal studies have shown the effectiveness of AZ for therapy of supraventricular and ventricular tachycardia (VT). Azimilide dihydrochloride was investigated as adjunctive treatment for reducing the frequency of VT and, thus, the need for ICD therapies, including ATP and cardioversion/defibrillation (ICD shocks) in patients with inducible monomorphic VT.

METHODS: A total of 172 patients were randomized to daily treatment with placebo, 35 mg, 75 mg, or 125 mg of oral AZ in this dose-ranging pilot study of patients with ICDs. The majority of patients had a history of documented remote myocardial infarction and congestive heart failure New York Heart Association class II or III.

RESULTS: The frequency of appropriate shocks and ATP were significantly decreased among AZ-treated patients compared with placebo patients. The incidence of ICD therapies per patient-year among the placebo group was 36, and it was 10, 12, and 9 among 35 mg, 75 mg, and 125 mg AZ patients, respectively (hazard ratio = 0.31, p = 0.0001). Azimilide dihydrochloride was generally well tolerated and did not affect left ventricular ejection fraction or minimal energy requirements for defibrillation or pacing.

CONCLUSIONS: Azimilide dihydrochloride may be a safe and effective drug for reducing the frequency of VT and ventricular fibrillation in patients with implanted ICDs.

Abbreviations and Acronyms   AE = adverse event   ATP = anti-tachycardia pacing   AZ = azimilide dihydrochloride   EGM = electrogram   HR = hazard ratio   ICD = implantable cardioverter defibrillator   IKr = rapid component of cardiac potassium channels   IKs = slow component of cardiac potassium channels   LVEF = left ventricular ejection fraction   PVC = premature ventricular contraction   TdP = Torsade de Pointes   VF = ventricular fibrillation   VT = ventricular tachycardia

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