A randomized, controlled trial of RSD1235, a novel anti-arrhythmic agent, in the treatment of recent onset atrial fibrillation
| Autor: | Denis Roy, Brian H. Rowe, Jacques S. Lee, John Ip, Denis C. Phaneuf, Ian G. Stiell, Sheila Grant, Benoit Coutu, Garth Dickinson, Humberto Vidaillet, Alan M. Ezrin, Gregory N. Beatch |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male Randomization medicine.medical_treatment Antiarrhythmic agent Placebo law.invention Vernakalant chemistry.chemical_compound Double-Blind Method Randomized controlled trial Heart Rate law Atrial Fibrillation Humans Medicine Sinus rhythm Infusions Intravenous Adverse effect Aged Aged 80 and over Dose-Response Relationship Drug business.industry Hemodynamics Electroencephalography Atrial fibrillation Middle Aged medicine.disease Treatment Outcome chemistry Anesthesia Female Cardiology and Cardiovascular Medicine business Anti-Arrhythmia Agents Follow-Up Studies |
| Zdroj: | Journal of the American College of Cardiology. 44:2355-2361 |
| ISSN: | 0735-1097 |
| DOI: | 10.1016/j.jacc.2004.09.021 |
| Popis: | OBJECTIVES The purpose of this study was to determine the efficacy and safety of intravenous RSD1235 in terminating recent onset atrial fibrillation (AF). BACKGROUND Anti-arrhythmic drugs currently available to terminate AF have limited efficacy and safety. RSD1235 is a novel atrial selective anti-arrhythmic drug. METHODS This was a phase II, multi-centered, randomized, double-blinded, step-dose, placebo-controlled, parallel group study. Fifty-six patients from 15 U.S. and Canadian sites with AF of 3 to 72 h duration were randomized to one of two RSD1235 dose groups or to placebo. The two RSD1235 groups were RSD-1 (0.5 mg/kg followed by 1 mg/kg) or RSD-2 (2 mg/kg followed by 3 mg/kg), by intravenous infusion over 10 min; a second dose was given only if AF was present. The primary end point was termination of AF during infusion or within 30-min after the last infusion. Secondary end points included the number of patients in sinus rhythm at 0.5, 1, and 24 h post-last infusion and time to conversion to sinus rhythm. RESULTS The RSD-2 dose showed significant differences over placebo in: 1) termination of AF (61% vs. 5%, p < 0.0005); 2) patients in sinus rhythm at 30 min (56% vs. 5%, p < 0.001); 3) sinus rhythm at 1 h (53% vs. 5%, p = 0.0014); and 4) median time to conversion to SR (14 vs. 162 min, p = 0.016). There were no serious adverse events related to RSD1235. CONCLUSIONS RSD1235, a new atrial-selective anti-arrhythmic agent, appears to be efficacious and safe for converting recent onset AF to sinus rhythm. |
| Databáze: | OpenAIRE |
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