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
N1 - Funding Information:
T. Yamashita has received research grants from Boehringer-Ingelheim and Daiichi-Sankyo, and honoraria from Boehringer-Ingelheim, Bayer, Bristol-Myers Squibb, Pfizer, and Daiichi-Sankyo.
Funding Information:
The study was supported by the Waksman Foundation of Japan Inc. We are grateful to Mebix, Inc. for data management, statistics, and preparing the manuscript. We are also grateful to Prof. Hideyuki Hiraishi, Dokkyo Medical University, for the special advice in the evaluation of dyspepsia.
Funding Information:
T. Ikeda is on the advisory panel of Boehringer-Ingelheim, Bayer, Bristol-Myers Squibb, and Pfizer. and received research support from Boehringer-Ingelheim, Bayer, and Bristol-Myers Squibb, and honoraria for lecture fees from Boehringer-Ingelheim, Bayer, Bristol-Myers Squibb, and Pfizer.
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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U2 - 10.1016/j.joa.2014.02.011
DO - 10.1016/j.joa.2014.02.011
M3 - Article
AN - SCOPUS:84919456547
SN - 1880-4276
VL - 30
SP - 478
EP - 484
JO - journal of arrhythmia
JF - journal of arrhythmia
IS - 6
ER -