Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation
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 tr...
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| Format: | Article |
| Language: | English |
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Wiley
2014-12-01
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| Series: | Journal of Arrhythmia |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1880427614000441 |
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| author | Takeshi Yamashita, FJCC, MD, PhD 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 |
| author_facet | Takeshi Yamashita, FJCC, MD, PhD 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 |
| author_sort | Takeshi Yamashita, FJCC, MD, PhD |
| collection | DOAJ |
| description | 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.
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 ≤2), 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). |
| first_indexed | 2024-04-12T17:10:25Z |
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| institution | Directory Open Access Journal |
| issn | 1880-4276 |
| language | English |
| last_indexed | 2024-04-12T17:10:25Z |
| publishDate | 2014-12-01 |
| publisher | Wiley |
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| series | Journal of Arrhythmia |
| spelling | doaj.art-86f2b97437fd40d7a377fc4c0deb7d4c2022-12-22T03:23:50ZengWileyJournal of Arrhythmia1880-42762014-12-0130647848410.1016/j.joa.2014.02.011Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillationTakeshi Yamashita, FJCC, MD, PhD0Eiichi Watanabe1Takanori Ikeda2Tsuyoshi Shiga3Kengo F. Kusano4Naohiko Takahashi5Toshiyuki Takahashi6Akira Nozaki7Masashi Kasao8Tohru Fukatsu9Yuichiro Kawamura10Takashi Komatsu11Naoki Matsumoto12Tomoharu Arakawa13Atsushi Sugiura14Tetsu Iwao15Tatsuhiko Ooie16Department of Cardiovascular Medicine, The Cardiovascular Institute, 3-2-19 Nishiazabu, Minato-Ku, Tokyo 106-0031, JapanDepartment of Cardiology, Fujita Health University School of Medicine, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JapanDepartment of Cardiovascular Medicine, Toho University Faculty of Medicine, 6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, JapanDepartment of Cardiology, Tokyo Women׳s Medical University Hospital, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, JapanDepartment of Cardiovascular Medicine, National Cerebral Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, JapanDepartment of Cardiology and Clinical Examination, Oita University Hospital, 1-1 Idaigaoka, Yufu City, Oita 879-5593, JapanDepartment of Cardiovascular Medicine, JR Tokyo General Hospital, 2-1-3 Yoyogi, Shibuya-ku, Tokyo 151-8528, JapanDepartment of Cardiovascular Medicine, Kanto Central Hospital of the Mutual Aid Association of Public School Teachers, 6-25-1 Kamiyoga, Setagaya-ku, Tokyo 158-8531, JapanDepartment of Cardiology, Tokyo Metropolitan Police Hospital, 4-22-1 Nakano, Nakano-ku, Tokyo 164-8541, JapanCardiology Department, Tokyo Teishin Hospital, 2-14-23 Fujimi, Chiyoda-ku, Tokyo 102-8798, JapanDepartment of Cardiology, Asahikawa Medical University Hospital, 2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido 078-8510, JapanDepartment of Internal Medicine, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate 025-0305, JapanDepartment of Pharmacogenomics, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ward, Kawasaki, Kanagawa 216-8511, JapanDepartment of Cardiology, Daido Hospital, 9 Hakusui-cho, Minami-ku, Nagoya, Aichi 457-8511, JapanDepartment of Internal Medicine, Hekinan Municipal Hospital, 3-6 Heiwa-machi, Hekinan, Aichi 447-8502, JapanDepartment of Cardiology, Oita Red Cross Hospital, 3-2-37, Chiyo-machi, Oita, Oita 870-0033, JapanDepartment of Cardiovascular Medicine, Oita Medical Center, 2-11-45 Yokota, Oita, Oita, Oita 870-0263, JapanBackground: 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. 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 ≤2), 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).http://www.sciencedirect.com/science/article/pii/S1880427614000441DabigatranDigestive symptomsAtrial fibrillationObservational studyAdverse reactions |
| spellingShingle | Takeshi Yamashita, FJCC, MD, PhD 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 Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation Journal of Arrhythmia Dabigatran Digestive symptoms Atrial fibrillation Observational study Adverse reactions |
| title | Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation |
| title_full | Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation |
| title_fullStr | Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation |
| title_full_unstemmed | Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation |
| title_short | Observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non-valvular atrial fibrillation |
| title_sort | observational study of the effects of dabigatran on gastrointestinal symptoms in patients with non valvular atrial fibrillation |
| topic | Dabigatran Digestive symptoms Atrial fibrillation Observational study Adverse reactions |
| url | http://www.sciencedirect.com/science/article/pii/S1880427614000441 |
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