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A cross-sectional survey of hospitalization and blood tests implementation status in patients who received tolvaptan under 75 years of age using a Japanese claims database
| Title: | A cross-sectional survey of hospitalization and blood tests implementation status in patients who received tolvaptan under 75 years of age using a Japanese claims database |
| Authors: | Imai, Shungo Browse this author →KAKEN DB | | Momo, Kenji Browse this author | | Kashiwagi, Hitoshi Browse this author | | Sato, Yuki Browse this author | | Miyai, Takayuki Browse this author | | Sugawara, Mitsuru Browse this author | | Takekuma, Yoh Browse this author →KAKEN DB |
| Keywords: | Blood test | | hypernatremia | | insurance claims | | liver injury | | tolvaptan |
| Issue Date: | 3-Oct-2021 |
| Publisher: | Taylor & Francis |
| Journal Title: | Expert Opinion on Drug Safety |
| Volume: | 20 |
| Issue: | 10 |
| Start Page: | 1257 |
| End Page: | 1266 |
| Publisher DOI: | 10.1080/14740338.2021.1951219 |
| Abstract: | Background Hypernatremia and liver injury are typical adverse effects of tolvaptan. Therefore, hospitalization and frequent monitoring of serum sodium concentration and liver function are necessary for tolvaptan initiation. We performed a cross-sectional survey to evaluate these situations. Research design and methods We employed the Japanese claims database, which contains data of patients aged < 75 years. Patients who were newly prescribed tolvaptan for fluid accumulation induced by chronic heart failure (FA-CHF) or liver cirrhosis (FA-LC) from January 2011 to June 2017 were included. We evaluated the hospitalization status and implementation of serum sodium and liver function tests in the evaluation period, based on the Japanese package insert. Results Of 1,173 patients, 347 and 117 were enrolled in FA-CHF and FA-LC groups, respectively. Among them, 10.7% (FA-CHF group) and 5.13% (FA-LC group) were prescribed tolvaptan without hospitalization. In the FA-CHF group, 11.0% and 17.6% did not undergo serum sodium and liver function tests even once in the evaluation period, respectively, compared with 12.0% and 12.8% in the FA-LC group. Conclusions Our results highlight the deviation from Japanese package insert recommendations. This approach can be applied to other drugs and provides important perspectives on pharmacovigilance research. |
| Type: | article (author version) |
| URI: | http://hdl.handle.net/2115/86882 |
| Appears in Collections: | 北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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Submitter: 今井 俊吾
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