Efficacy and safety of Saireito (TJ-114) in patients with atrial fibrillation undergoing catheter ablation procedures: A randomized pilot study.

<h4>Background</h4>Early arrhythmia recurrences commonly occur after atrial fibrillation (AF) ablation because of irritability and inflammation of left atrium. We hypothesized that short-term use of Saireito would be effective in reducing frequent atrial tachyarrhythmias in the early-pha...

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Main Authors: Tetsuma Kawaji, Satoshi Shizuta, Hidenori Yaku, Kazuhisa Kaneda, Fumiya Yoneda, Shushi Nishiwaki, Munekazu Tanaka, Takanori Aizawa, Shun Hojo, Kenji Nakatsuma, Masashi Kato, Takafumi Yokomatsu, Shinji Miki, Koh Ono, Takeshi Kimura
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2024-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0307854
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author Tetsuma Kawaji
Satoshi Shizuta
Hidenori Yaku
Kazuhisa Kaneda
Fumiya Yoneda
Shushi Nishiwaki
Munekazu Tanaka
Takanori Aizawa
Shun Hojo
Kenji Nakatsuma
Masashi Kato
Takafumi Yokomatsu
Shinji Miki
Koh Ono
Takeshi Kimura
author_facet Tetsuma Kawaji
Satoshi Shizuta
Hidenori Yaku
Kazuhisa Kaneda
Fumiya Yoneda
Shushi Nishiwaki
Munekazu Tanaka
Takanori Aizawa
Shun Hojo
Kenji Nakatsuma
Masashi Kato
Takafumi Yokomatsu
Shinji Miki
Koh Ono
Takeshi Kimura
author_sort Tetsuma Kawaji
collection DOAJ
description <h4>Background</h4>Early arrhythmia recurrences commonly occur after atrial fibrillation (AF) ablation because of irritability and inflammation of left atrium. We hypothesized that short-term use of Saireito would be effective in reducing frequent atrial tachyarrhythmias in the early-phase post-ablation.<h4>Methods</h4>One hundred patients undergoing catheter ablation for symptomatic AF were randomly assigned to either a 30-day use of Saireito or control group. The primary endpoint was total number of episodes of frequent atrial tachyarrhythmias including definite recurrent AF and frequent premature atrial contractions during the 30-day treatment period post-ablation.<h4>Results</h4>Three (6.0%) out of 50 patients treated with Saireito discontinued the drug because of adverse symptoms. The Saireito group was associated with a numerically lower number of episodes of frequent atrial tachyarrhythmias than the control group (3.1 versus 5.2 times, P = 0.17). The mean daily episodes of frequent atrial tachyarrhythmias were significantly fewer in the Saireito group during Day-6 to Day-10 (0.12/day versus 0.27/day, P = 0.03), and during Day-11 to Day-15 (0.08/day versus 0.24/day, P = 0.001). The prevalence of adverse symptoms during the 30-day treatment period was significantly higher in the Saireito group (18.0% versus 2.0%, P = 0.005).<h4>Conclusions</h4>Thirty-day use of Saireito following AF ablation was associated with a tendency toward reduced number of episodes of frequent atrial tachyarrhythmias during the treatment period, with more pronounced effect in the first two weeks.
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spelling doaj-art-4f1f6b3ff64143ef927ce31db7f200302025-01-29T05:30:47ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01198e030785410.1371/journal.pone.0307854Efficacy and safety of Saireito (TJ-114) in patients with atrial fibrillation undergoing catheter ablation procedures: A randomized pilot study.Tetsuma KawajiSatoshi ShizutaHidenori YakuKazuhisa KanedaFumiya YonedaShushi NishiwakiMunekazu TanakaTakanori AizawaShun HojoKenji NakatsumaMasashi KatoTakafumi YokomatsuShinji MikiKoh OnoTakeshi Kimura<h4>Background</h4>Early arrhythmia recurrences commonly occur after atrial fibrillation (AF) ablation because of irritability and inflammation of left atrium. We hypothesized that short-term use of Saireito would be effective in reducing frequent atrial tachyarrhythmias in the early-phase post-ablation.<h4>Methods</h4>One hundred patients undergoing catheter ablation for symptomatic AF were randomly assigned to either a 30-day use of Saireito or control group. The primary endpoint was total number of episodes of frequent atrial tachyarrhythmias including definite recurrent AF and frequent premature atrial contractions during the 30-day treatment period post-ablation.<h4>Results</h4>Three (6.0%) out of 50 patients treated with Saireito discontinued the drug because of adverse symptoms. The Saireito group was associated with a numerically lower number of episodes of frequent atrial tachyarrhythmias than the control group (3.1 versus 5.2 times, P = 0.17). The mean daily episodes of frequent atrial tachyarrhythmias were significantly fewer in the Saireito group during Day-6 to Day-10 (0.12/day versus 0.27/day, P = 0.03), and during Day-11 to Day-15 (0.08/day versus 0.24/day, P = 0.001). The prevalence of adverse symptoms during the 30-day treatment period was significantly higher in the Saireito group (18.0% versus 2.0%, P = 0.005).<h4>Conclusions</h4>Thirty-day use of Saireito following AF ablation was associated with a tendency toward reduced number of episodes of frequent atrial tachyarrhythmias during the treatment period, with more pronounced effect in the first two weeks.https://doi.org/10.1371/journal.pone.0307854
spellingShingle Tetsuma Kawaji
Satoshi Shizuta
Hidenori Yaku
Kazuhisa Kaneda
Fumiya Yoneda
Shushi Nishiwaki
Munekazu Tanaka
Takanori Aizawa
Shun Hojo
Kenji Nakatsuma
Masashi Kato
Takafumi Yokomatsu
Shinji Miki
Koh Ono
Takeshi Kimura
Efficacy and safety of Saireito (TJ-114) in patients with atrial fibrillation undergoing catheter ablation procedures: A randomized pilot study.
PLoS ONE
title Efficacy and safety of Saireito (TJ-114) in patients with atrial fibrillation undergoing catheter ablation procedures: A randomized pilot study.
title_full Efficacy and safety of Saireito (TJ-114) in patients with atrial fibrillation undergoing catheter ablation procedures: A randomized pilot study.
title_fullStr Efficacy and safety of Saireito (TJ-114) in patients with atrial fibrillation undergoing catheter ablation procedures: A randomized pilot study.
title_full_unstemmed Efficacy and safety of Saireito (TJ-114) in patients with atrial fibrillation undergoing catheter ablation procedures: A randomized pilot study.
title_short Efficacy and safety of Saireito (TJ-114) in patients with atrial fibrillation undergoing catheter ablation procedures: A randomized pilot study.
title_sort efficacy and safety of saireito tj 114 in patients with atrial fibrillation undergoing catheter ablation procedures a randomized pilot study
url https://doi.org/10.1371/journal.pone.0307854
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