Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation

Takeshi Yamashita, Eiichi Watanabe, Takanori Ikeda, Tsuyoshi Shiga, Kengo F. Kusano, Naohiko Takahashi, Toshiyuki Takahashi, Akira Nozaki, Masashi Kasao, Tohru Fukatsu, Yuichiro Kawamura, Takashi Komatsu, Naoki Matsumoto, Tomoharu Arakawa, Atsushi Sugiura, Tetsu Iwao, Tatsuhiko Ooie

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background Dyspepsia (including upper abdominal pain, abdominal pain, abdominal discomfort, epigastric discomfort, and dyspepsia) is a symptom that is carefully monitored during dabigatran treatment. However, detailed information on dyspepsia, including onset, duration, severity, and use of drug treatment, has not yet been established in Japanese patients. Copy; 2014 Japanese Heart Rhythm Society.

Methods We conducted a multi-center, prospective, open-label, randomized, and parallel-group-comparison observational study of 309 patients with non-valvular atrial fibrillation who had been newly prescribed dabigatran at 19 institutes in Japan. Gastrointestinal adverse events were evaluated using the Global Overall Severity (GOS) scale self-reports to describe symptoms and to assess frequency and severity of symptoms (Part 1). Thereafter, patients with a GOS score ≥3 were randomized to receive a 4-week course of a proton pump inhibitor, an H2-receptor antagonist or a gastric mucosal protective drug (Part 2).

Results The incidence of dyspepsia symptoms due to dabigatran was 17.2% (53/309, 95% confidence interval 13.1-21.8%), with 77% of events occurring within 10 days of initiation. Five patients discontinued the study because of dyspepsia. At the end of the observation period, the mean GOS score of those reporting dyspepsia was 3.5±1.7, with 11.3% (35/309) reporting a score ≥3. Substantial differences in the incidence of dyspepsia were observed between the study institutes (0-41%). In the multivariate regression analysis, no significant factor was found to affect incidence or severity of dyspepsia. The majority (83-100%) reported that symptoms improved with treatment (GOS score ≤), and there was no significant difference between the three different treatment groups.

Conclusions The reported symptoms of dyspepsia were generally mild, but were moderate in approximately 10% of patients. Proton pump inhibitors, H2-receptor antagonists, and rebamipide seemed to be equally effective in relieving dabigatran-related dyspepsia (umin-CTR UMIN000007579).

Original languageEnglish
Pages (from-to)478-484
Number of pages7
Journaljournal of arrhythmia
Volume30
Issue number6
DOIs
Publication statusPublished - 01-12-2014

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Dyspepsia
Atrial Fibrillation
Observational Studies
Histamine H2 Receptors
Proton Pump Inhibitors
Abdominal Pain
Incidence
Dabigatran
Protective Agents
Therapeutics
Self Report
Stomach
Japan
Multivariate Analysis
Regression Analysis
Observation
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Yamashita, Takeshi ; Watanabe, Eiichi ; Ikeda, Takanori ; Shiga, Tsuyoshi ; Kusano, Kengo F. ; Takahashi, Naohiko ; Takahashi, Toshiyuki ; Nozaki, Akira ; Kasao, Masashi ; Fukatsu, Tohru ; Kawamura, Yuichiro ; Komatsu, Takashi ; Matsumoto, Naoki ; Arakawa, Tomoharu ; Sugiura, Atsushi ; Iwao, Tetsu ; Ooie, Tatsuhiko. / Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation. In: journal of arrhythmia. 2014 ; Vol. 30, No. 6. pp. 478-484.
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abstract = "Background Dyspepsia (including upper abdominal pain, abdominal pain, abdominal discomfort, epigastric discomfort, and dyspepsia) is a symptom that is carefully monitored during dabigatran treatment. However, detailed information on dyspepsia, including onset, duration, severity, and use of drug treatment, has not yet been established in Japanese patients. Copy; 2014 Japanese Heart Rhythm Society.Methods We conducted a multi-center, prospective, open-label, randomized, and parallel-group-comparison observational study of 309 patients with non-valvular atrial fibrillation who had been newly prescribed dabigatran at 19 institutes in Japan. Gastrointestinal adverse events were evaluated using the Global Overall Severity (GOS) scale self-reports to describe symptoms and to assess frequency and severity of symptoms (Part 1). Thereafter, patients with a GOS score ≥3 were randomized to receive a 4-week course of a proton pump inhibitor, an H2-receptor antagonist or a gastric mucosal protective drug (Part 2).Results The incidence of dyspepsia symptoms due to dabigatran was 17.2{\%} (53/309, 95{\%} confidence interval 13.1-21.8{\%}), with 77{\%} of events occurring within 10 days of initiation. Five patients discontinued the study because of dyspepsia. At the end of the observation period, the mean GOS score of those reporting dyspepsia was 3.5±1.7, with 11.3{\%} (35/309) reporting a score ≥3. Substantial differences in the incidence of dyspepsia were observed between the study institutes (0-41{\%}). In the multivariate regression analysis, no significant factor was found to affect incidence or severity of dyspepsia. The majority (83-100{\%}) reported that symptoms improved with treatment (GOS score ≤), and there was no significant difference between the three different treatment groups.Conclusions The reported symptoms of dyspepsia were generally mild, but were moderate in approximately 10{\%} of patients. Proton pump inhibitors, H2-receptor antagonists, and rebamipide seemed to be equally effective in relieving dabigatran-related dyspepsia (umin-CTR UMIN000007579).",
author = "Takeshi Yamashita and Eiichi Watanabe and Takanori Ikeda and Tsuyoshi Shiga and Kusano, {Kengo F.} and Naohiko Takahashi and Toshiyuki Takahashi and Akira Nozaki and Masashi Kasao and Tohru Fukatsu and Yuichiro Kawamura and Takashi Komatsu and Naoki Matsumoto and Tomoharu Arakawa and Atsushi Sugiura and Tetsu Iwao and Tatsuhiko Ooie",
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Yamashita, T, Watanabe, E, Ikeda, T, Shiga, T, Kusano, KF, Takahashi, N, Takahashi, T, Nozaki, A, Kasao, M, Fukatsu, T, Kawamura, Y, Komatsu, T, Matsumoto, N, Arakawa, T, Sugiura, A, Iwao, T & Ooie, T 2014, 'Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation', journal of arrhythmia, vol. 30, no. 6, pp. 478-484. https://doi.org/10.1016/j.joa.2014.02.011

Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation. / Yamashita, Takeshi; Watanabe, Eiichi; Ikeda, Takanori; Shiga, Tsuyoshi; Kusano, Kengo F.; Takahashi, Naohiko; Takahashi, Toshiyuki; Nozaki, Akira; Kasao, Masashi; Fukatsu, Tohru; Kawamura, Yuichiro; Komatsu, Takashi; Matsumoto, Naoki; Arakawa, Tomoharu; Sugiura, Atsushi; Iwao, Tetsu; Ooie, Tatsuhiko.

In: journal of arrhythmia, Vol. 30, No. 6, 01.12.2014, p. 478-484.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation

AU - Yamashita, Takeshi

AU - Watanabe, Eiichi

AU - Ikeda, Takanori

AU - Shiga, Tsuyoshi

AU - Kusano, Kengo F.

AU - Takahashi, Naohiko

AU - Takahashi, Toshiyuki

AU - Nozaki, Akira

AU - Kasao, Masashi

AU - Fukatsu, Tohru

AU - Kawamura, Yuichiro

AU - Komatsu, Takashi

AU - Matsumoto, Naoki

AU - Arakawa, Tomoharu

AU - Sugiura, Atsushi

AU - Iwao, Tetsu

AU - Ooie, Tatsuhiko

PY - 2014/12/1

Y1 - 2014/12/1

N2 - Background Dyspepsia (including upper abdominal pain, abdominal pain, abdominal discomfort, epigastric discomfort, and dyspepsia) is a symptom that is carefully monitored during dabigatran treatment. However, detailed information on dyspepsia, including onset, duration, severity, and use of drug treatment, has not yet been established in Japanese patients. Copy; 2014 Japanese Heart Rhythm Society.Methods We conducted a multi-center, prospective, open-label, randomized, and parallel-group-comparison observational study of 309 patients with non-valvular atrial fibrillation who had been newly prescribed dabigatran at 19 institutes in Japan. Gastrointestinal adverse events were evaluated using the Global Overall Severity (GOS) scale self-reports to describe symptoms and to assess frequency and severity of symptoms (Part 1). Thereafter, patients with a GOS score ≥3 were randomized to receive a 4-week course of a proton pump inhibitor, an H2-receptor antagonist or a gastric mucosal protective drug (Part 2).Results The incidence of dyspepsia symptoms due to dabigatran was 17.2% (53/309, 95% confidence interval 13.1-21.8%), with 77% of events occurring within 10 days of initiation. Five patients discontinued the study because of dyspepsia. At the end of the observation period, the mean GOS score of those reporting dyspepsia was 3.5±1.7, with 11.3% (35/309) reporting a score ≥3. Substantial differences in the incidence of dyspepsia were observed between the study institutes (0-41%). In the multivariate regression analysis, no significant factor was found to affect incidence or severity of dyspepsia. The majority (83-100%) reported that symptoms improved with treatment (GOS score ≤), and there was no significant difference between the three different treatment groups.Conclusions The reported symptoms of dyspepsia were generally mild, but were moderate in approximately 10% of patients. Proton pump inhibitors, H2-receptor antagonists, and rebamipide seemed to be equally effective in relieving dabigatran-related dyspepsia (umin-CTR UMIN000007579).

AB - Background Dyspepsia (including upper abdominal pain, abdominal pain, abdominal discomfort, epigastric discomfort, and dyspepsia) is a symptom that is carefully monitored during dabigatran treatment. However, detailed information on dyspepsia, including onset, duration, severity, and use of drug treatment, has not yet been established in Japanese patients. Copy; 2014 Japanese Heart Rhythm Society.Methods We conducted a multi-center, prospective, open-label, randomized, and parallel-group-comparison observational study of 309 patients with non-valvular atrial fibrillation who had been newly prescribed dabigatran at 19 institutes in Japan. Gastrointestinal adverse events were evaluated using the Global Overall Severity (GOS) scale self-reports to describe symptoms and to assess frequency and severity of symptoms (Part 1). Thereafter, patients with a GOS score ≥3 were randomized to receive a 4-week course of a proton pump inhibitor, an H2-receptor antagonist or a gastric mucosal protective drug (Part 2).Results The incidence of dyspepsia symptoms due to dabigatran was 17.2% (53/309, 95% confidence interval 13.1-21.8%), with 77% of events occurring within 10 days of initiation. Five patients discontinued the study because of dyspepsia. At the end of the observation period, the mean GOS score of those reporting dyspepsia was 3.5±1.7, with 11.3% (35/309) reporting a score ≥3. Substantial differences in the incidence of dyspepsia were observed between the study institutes (0-41%). In the multivariate regression analysis, no significant factor was found to affect incidence or severity of dyspepsia. The majority (83-100%) reported that symptoms improved with treatment (GOS score ≤), and there was no significant difference between the three different treatment groups.Conclusions The reported symptoms of dyspepsia were generally mild, but were moderate in approximately 10% of patients. Proton pump inhibitors, H2-receptor antagonists, and rebamipide seemed to be equally effective in relieving dabigatran-related dyspepsia (umin-CTR UMIN000007579).

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