TY - JOUR
T1 - Vernakalant hydrochloride for rapid conversion of atrial fibrillation - A phase 3, randomized, placebo-controlled trial
AU - Roy, D.
AU - Pratt, C.M.
AU - Torp-Pedersen, C.
AU - Wyse, D.G.
AU - Toft, E.
AU - Juul-Moller, S.
AU - Nielsen, T.
AU - Rasmussen, S.L.
AU - Stiell, I.G.
AU - Coutu, B.
AU - Ip, J.H.
AU - Pritchett, E.L.C.
AU - Camm, A.J.
N1 - Times Cited: 3ArticleEnglishRoy, DUniv Montreal, Montreal Heart Inst, 5000 Belanger St, Montreal, PQ H1T 1C8, CanadaCited References Count: 32278PJLIPPINCOTT WILLIAMS & WILKINS530 WALNUT ST, PHILADELPHIA, PA 19106-3621 USAPHILADELPHIA
PY - 2008
Y1 - 2008
N2 - Background - The present study assessed the efficacy and safety of vernakalant hydrochloride ( RSD1235), a novel compound, for the conversion of atrial fibrillation ( AF). Methods and Results - Patients were randomized in a 2: 1 ratio to receive vernakalant or placebo and were stratified by AF duration of 3 hours to 7 days ( short duration) and 8 to 45 days ( long duration). A first infusion of placebo or vernakalant ( 3 mg/kg) was given for 10 minutes, followed by a second infusion of placebo or vernakalant ( 2 mg/kg) 15 minutes later if AF was not terminated. The primary end point was conversion of AF to sinus rhythm for at least 1 minute within 90 minutes of the start of drug infusion in the short-duration AF group. A total of 336 patients were randomized and received treatment (short duration, n = 220; long duration, n = 116). Of the 145 vernakalant patients, 75 (51.7%) in the short-duration AF group converted to sinus rhythm ( median time, 11 minutes) compared with 3 of the 75 placebo patients ( 4.0%; P < 0.001). Overall, in the short-and long-duration AF groups, 83 of the 221 vernakalant patients (37.6%) experienced termination of AF compared with 3 of the 115 placebo patients ( 2.6%; P < 0.001). Transient dysgeusia and sneezing were the most common side effects in vernakalant-treated patients. Four vernakalant-related serious adverse events (hypotension [ events], complete atrioventricular block, and cardiogenic shock) occurred in 3 patients. Conclusion - Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated
Udgivelsesdato: 2008/3/25
AB - Background - The present study assessed the efficacy and safety of vernakalant hydrochloride ( RSD1235), a novel compound, for the conversion of atrial fibrillation ( AF). Methods and Results - Patients were randomized in a 2: 1 ratio to receive vernakalant or placebo and were stratified by AF duration of 3 hours to 7 days ( short duration) and 8 to 45 days ( long duration). A first infusion of placebo or vernakalant ( 3 mg/kg) was given for 10 minutes, followed by a second infusion of placebo or vernakalant ( 2 mg/kg) 15 minutes later if AF was not terminated. The primary end point was conversion of AF to sinus rhythm for at least 1 minute within 90 minutes of the start of drug infusion in the short-duration AF group. A total of 336 patients were randomized and received treatment (short duration, n = 220; long duration, n = 116). Of the 145 vernakalant patients, 75 (51.7%) in the short-duration AF group converted to sinus rhythm ( median time, 11 minutes) compared with 3 of the 75 placebo patients ( 4.0%; P < 0.001). Overall, in the short-and long-duration AF groups, 83 of the 221 vernakalant patients (37.6%) experienced termination of AF compared with 3 of the 115 placebo patients ( 2.6%; P < 0.001). Transient dysgeusia and sneezing were the most common side effects in vernakalant-treated patients. Four vernakalant-related serious adverse events (hypotension [ events], complete atrioventricular block, and cardiogenic shock) occurred in 3 patients. Conclusion - Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated
Udgivelsesdato: 2008/3/25
M3 - Journal article
SN - 0009-7322
VL - 117
SP - 1518
EP - 1525
JO - Circulation
JF - Circulation
IS - 12
ER -