Efficacy and Safety of Vernakalant for Cardioversion of Recent-onset Atrial Fibrillation in the Asia–Pacific Region: A Phase 3 Randomized Controlled Trial
| Autor: | Gregory N. Beatch, Kiran Bhirangi, Jörg Rustige, Steen Juul-Möller |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Male
Asia Pyrrolidines medicine.medical_treatment Electric Countershock Taiwan India Anisoles 030204 cardiovascular system & hematology Placebo Cardioversion law.invention Vernakalant antiarrhythmic 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method cardioversion Randomized controlled trial law Atrial Fibrillation Republic of Korea Clinical endpoint Humans Medicine Sinus rhythm vernakalant hydrochloride 030212 general & internal medicine Adverse effect Aged Aged 80 and over Pharmacology sinus rhythm business.industry Atrial fibrillation Middle Aged medicine.disease Treatment Outcome chemistry Anesthesia Female Original Article Cardiology and Cardiovascular Medicine business Anti-Arrhythmia Agents |
| Zdroj: | Journal of Cardiovascular Pharmacology |
| ISSN: | 0160-2446 |
| Popis: | Atrial fibrillation (AF) is a common clinically significant cardiac arrhythmia. This phase 3 randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of vernakalant hydrochloride for the pharmacological conversion of AF to sinus rhythm in patients with recent-onset (>3 hours to ≤7 days) symptomatic AF from the Asia–Pacific region. Patients received an infusion of vernakalant (3 mg/kg) or placebo for 10 minutes. If AF had not been terminated 15 minutes later, a second infusion of vernakalant (2 mg/kg) or placebo for 15 minutes was administered. The primary efficacy end point was conversion of AF to sinus rhythm for >1 minute within 90 minutes. The study was terminated early for administrative reasons; 123 patients from Korea, Taiwan, and India were randomized to receive vernakalant (n = 55) or placebo (n = 56). A greater proportion of patients who received vernakalant (52.7%) than placebo (12.5%) met the primary end point (P < 0.001), and cardioversion was faster in the vernakalant group than in the placebo group (P < 0.001). Vernakalant was generally well tolerated; the incidence of treatment-emergent adverse events was similar between the groups. We conclude that vernakalant is efficacious in the rapid cardioversion of recent-onset AF in patients from the Asia–Pacific region. |
| Databáze: | OpenAIRE |
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