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Efficacy of azimilide for the maintenance of sinus rhythm in patients with paroxysmal atrial fibrillation in the presence and absence of structural heart disease.

Publication ,  Journal Article
Kerr, CR; Connolly, SJ; Kowey, P; Page, RL; Pritchett, ELC; Ruda, MY; Ruzyllo, W; Wilkinson, WE; A-STAR Investigators,
Published in: Am J Cardiol
July 15, 2006

Azimilide hydrochloride (azimilide), an investigational antiarrhythmic drug, has shown variable efficacy in preventing atrial fibrillation (AF). This study was designed to assess its efficacy in maintaining sinus rhythm in patients with paroxysmal AF and heart disease. Patients with symptomatic paroxysmal AF were screened for 1 month by transtelephonic monitoring. After recording 1 episode of AF in the screening period, they were randomized to receive azimilide 125 mg or placebo once daily. Patients were stratified by the presence or absence of congestive heart failure or coronary heart disease (CHF/CHD). A maximum of 220 patients without CHF/CHD were randomized, with the remainder having CHF/CHD. Patients with CHF/CHD were monitored for 3 days during loading. The primary efficacy analysis was the time to the first symptomatic recurrence of AF in the CHF/CHD group. Secondary analyses were the time to the first recurrence in the entire population and the time to the first recurrence in those with significant structural heart disease. The median time to recurrence of AF in the CHF/CHD group was 10 days in the 2 treatment arms. Nonsignificant trends were seen toward efficacy of azimilide in the CHF/CHD group (hazard ratio 1.28, 95% confidence interval 0.97 to 1.70, p=0.087), structural heart disease group (hazard ratio 1.22, 95% confidence interval 0.96 to 1.56, p=0.11), and overall group (hazard ratio 1.22, 95% confidence interval 1.00 to 1.49, p=0.053). No patient died. In conclusion, azimilide showed a nonsignificant trend toward efficacy in maintaining sinus rhythm in patients with AF.

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Published In

Am J Cardiol

DOI

ISSN

0002-9149

Publication Date

July 15, 2006

Volume

98

Issue

2

Start / End Page

215 / 218

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tachycardia, Paroxysmal
  • Piperazines
  • Middle Aged
  • Male
  • Imidazolidines
  • Hydantoins
  • Humans
  • Heart Rate
  • Heart Failure
 

Citation

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Kerr, C. R., Connolly, S. J., Kowey, P., Page, R. L., Pritchett, E. L. C., Ruda, M. Y., … A-STAR Investigators, . (2006). Efficacy of azimilide for the maintenance of sinus rhythm in patients with paroxysmal atrial fibrillation in the presence and absence of structural heart disease. Am J Cardiol, 98(2), 215–218. https://doi.org/10.1016/j.amjcard.2006.01.084
Kerr, Charles R., Stuart J. Connolly, Peter Kowey, Richard L. Page, Edward L. C. Pritchett, Mikhail Y. Ruda, Witold Ruzyllo, William E. Wilkinson, and William E. A-STAR Investigators. “Efficacy of azimilide for the maintenance of sinus rhythm in patients with paroxysmal atrial fibrillation in the presence and absence of structural heart disease.Am J Cardiol 98, no. 2 (July 15, 2006): 215–18. https://doi.org/10.1016/j.amjcard.2006.01.084.
Kerr CR, Connolly SJ, Kowey P, Page RL, Pritchett ELC, Ruda MY, et al. Efficacy of azimilide for the maintenance of sinus rhythm in patients with paroxysmal atrial fibrillation in the presence and absence of structural heart disease. Am J Cardiol. 2006 Jul 15;98(2):215–8.
Kerr, Charles R., et al. “Efficacy of azimilide for the maintenance of sinus rhythm in patients with paroxysmal atrial fibrillation in the presence and absence of structural heart disease.Am J Cardiol, vol. 98, no. 2, July 2006, pp. 215–18. Pubmed, doi:10.1016/j.amjcard.2006.01.084.
Kerr CR, Connolly SJ, Kowey P, Page RL, Pritchett ELC, Ruda MY, Ruzyllo W, Wilkinson WE, A-STAR Investigators. Efficacy of azimilide for the maintenance of sinus rhythm in patients with paroxysmal atrial fibrillation in the presence and absence of structural heart disease. Am J Cardiol. 2006 Jul 15;98(2):215–218.
Journal cover image

Published In

Am J Cardiol

DOI

ISSN

0002-9149

Publication Date

July 15, 2006

Volume

98

Issue

2

Start / End Page

215 / 218

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tachycardia, Paroxysmal
  • Piperazines
  • Middle Aged
  • Male
  • Imidazolidines
  • Hydantoins
  • Humans
  • Heart Rate
  • Heart Failure