https://orcid.org/0000-0001-5706-613X
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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.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
A reviewer on this manuscript has previously served as a consultant to Otsuka, the manufacturer of tolvaptan. A separate reviewer on this manuscript has been a consultant to Otsuka in the past, and has spoken at Otsuka-sponsored educational events. A further reviewer on this manuscript has declared honoraria and consultation with Otsuka.
Data availability statement
The datasets generated and analyzed during the current study are not publicly available because they are proprietary but may be available from the corresponding author upon reasonable request.
Author contributions
SI and YT conceived the study idea and designed the study. KM, HK, TM, YS, and SM assisted with the research design. KM provided epidemiological data. SI and YT performed the statistical analyses. KM, HK, TM, YS, and SM assisted with performing statistical analyses. SI and YT wrote the manuscript. KM, HK, TM, YS, and SM contributed equally to this work. All authors have read and approved the final version of the manuscript.