Arrhythmias and conduction disturbancesUsefulness of Vernakalant Hydrochloride Injection for Rapid Conversion of Atrial Fibrillation
Section snippets
Methods
The present study was a prospective, randomized, double-blind, placebo-controlled international trial conducted from June 27, 2004 to August 1, 2005. The institutional or regional review board at each site approved the protocol, and the patients gave written informed consent before starting the study procedures. An unblinded independent data safety monitoring board was used throughout the trial. The sponsors and members of the steering committee had full access to the data. The sponsor
Results
The disposition of the 276 study patients is depicted in Figure 2. No patient had previously participated in a vernakalant study, including ACT I. The baseline demographics and baseline medical therapies are listed in Table 1. The treatment groups were relatively well-balanced. Of the 86 vernakalant patients in the primary efficacy group, 44 (51.2%) demonstrated conversion to SR for ≥1 minute within 90 minutes of infusion (primary efficacy end point) compared to 3 (3.6%) of the 84 placebo
Discussion
In the present study, vernakalant was effective in converting short-duration AF (51.2% compared to 3.6% of placebo patients). However, vernakalant was ineffective for AFL.
The results of the present study are consistent with those of the ACT-I.5 For patients with short-duration AF, conversion to SR with vernakalant was rapid. From the initiation of the infusion, the median interval to conversion in the present trial (8 minutes) was similar to that in ACT I (11 minutes).5 In both the present
Acknowledgment
We thank the nurse coordinators at the participating sites for their cooperation with the present study, and Therese Kitt, MD, Bruce McNutt, MD, Bo Yan, PhD, and Jimmy Wang, PhD, of Astellas Pharma US, Inc. (Deerfield, Illinois), Greg Beatch, PhD, Garth Dickinson, MD, Sheila Grant, BS, MBA, and Brian Mangal, MS, of Cardiome Pharma, Corp. (Vancouver, Canada), and David S. Berger, PhD, who served as a medical writer, and Kara L. Guarini, PhD, from JL Shapiro Associates, Inc (Edison, New Jersey).
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Cited by (108)
The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation
2020, Canadian Journal of CardiologyCitation Excerpt :The major side effects are hypotension and bradycardia after cardioversion.551,554,555 Transient but fairly common side effects include dysgeusia, paresthesia, and nausea.544,551,554,555 Vernakalant is not effective for the conversion of AFL; and should be avoided in patients with hypotension, severe HF (NYHA classification III/IV), bradycardia, recent ACS, or severe aortic stenosis.552,555,556
Rhythm control in atrial fibrillation
2016, The LancetCitation Excerpt :Vernakalant targets multiple ion channels, including the atrial selective acetylcholine-activated potassium current (IK,Ach) and was approved for pharmacological cardioversion by the European Medicines Agency in 2010. In clinical trials, vernakalant converted 51% of patients with short duration atrial fibrillation (3 h to 7 days) with a median time to conversion of 10 min.15,16 The initial dose is 3 mg/kg dose over 10 min and a second infusion of 2 mg/kg can be given if atrial fibrillation persists after 10 min.
Bayesian Network Meta-analysis of Randomized Controlled Trials on the Efficacy of Antiarrhythmics in the Pharmacological Cardioversion of Paroxysmal Atrial Fibrillation
2023, American Journal of Cardiovascular Drugs
This study was sponsored by Astellas Pharma US, Inc., Deerfield, Illinois and Cardiome Pharma Corp., Vancouver, British Columbia, Canada.
Drs. Pratt, Roy, and Wyse have previously received consulting fees from Cardiome or Astellas.