Sensory evaluation of edoxaban orally disintegrating tablets: an open-label interventional study (secondary publication)

Takeshi Yamashita,Tetsuya Kimura,Takaaki Akasaka,Takuyuki Matsumoto,Yoshiyuki Morishima,Joji Hagii

doi:10.1186/s12959-019-0192-x

Takeshi Yamashita, Tetsuya Kimura + Show 4 more

Open Access

https://doi.org/10.1186/s12959-019-0192-x

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Abstract

BackgroundThis study involved a sensory evaluation of edoxaban orally disintegrating (OD) tablets in patients with nonvalvular atrial fibrillation who had been receiving the existing edoxaban film-coated tablets before the study.MethodsEdoxaban OD tablets 30 or 60 mg were prescribed for patients who had been receiving the existing 30- or 60-mg edoxaban film-coated tablets before the study. Each dose group was randomized into groups taking the tablets with or without water. After ingestion of the edoxaban OD tablet, each patient was asked to complete a sensory evaluation questionnaire (12 items).ResultsIn the evaluation of satisfaction with edoxaban OD tablets, 52.8% of the patients perceived “no difference” from the existing edoxaban film-coated tablets and 34.9% indicated that they were more satisfied with the OD tablets, thus demonstrating a relatively high degree of satisfaction. When asked about convenience and reliability in using edoxaban OD tablets, about half of the patients perceived “no difference” from the existing edoxaban film-coated tablets and the remaining half indicated preference for the OD tablets. Responses about taste, flavor, ease of ingestion, and motivation to continue taking edoxaban indicated the overall acceptance of the OD tablets. Recognition of edoxaban OD tablets was rated as “easy” by about half of the patients and “difficult” by the remaining half. Among all patients, 49.5% preferred a change to edoxaban OD tablets. The degree of satisfaction with taste, flavor, and ease of ingestion, as well as overall satisfaction, tended to be greater when the OD tablets were taken with rather than without water, and the percentage of patients who preferred a change was higher in the group taking the OD tablets with water.ConclusionsThis study indicated that the degree of satisfaction with taste, flavor, ease of ingestion, and convenience, as well as overall satisfaction, in addition to motivation to continue drug intake and sense of confidence were greater for OD tablets than for the existing edoxaban film-coated tablets. Edoxaban OD tablet is a promising formulation for inducing greater patient adherence to medication and therefore ensures better treatment response.Trial registrationUMIN-CTR UMIN000028788, registered 23-Aug-2017.

Highlights

This study involved a sensory evaluation of edoxaban orally disintegrating (OD) tablets in patients with nonvalvular atrial fibrillation who had been receiving the existing edoxaban film-coated tablets before the study
The 66 patients who were receiving 30-mg edoxaban film-coated tablets before the start of the study were allocated to group 1 (30-mg edoxaban OD tablet without water; n = 33) and group 3 (30-mg edoxaban OD tablet with water; n = 33)
This study shows that the degree of satisfaction, taste/flavor, and ease of ingestion were rated higher in the group that ingested the drug with water, which suggests that the advantages of edoxaban OD tablets are better manifested when it is taken with water

Summary

Introduction

This study involved a sensory evaluation of edoxaban orally disintegrating (OD) tablets in patients with nonvalvular atrial fibrillation who had been receiving the existing edoxaban film-coated tablets before the study. Decreased medication adherence in these patients could be attributable to difficulty of taking standard tablets. Improvement of medication adherence is essential for a safe and effective anticoagulant therapy, as anticoagulants require long-term use. Use of orally disintegrating (OD) tablets is one way of improving medication adherence. OD tablets are easy to be taken by patients with restricted water ingestion, the elderly, and those with difficulty swallowing because they readily disintegrate in the oral cavity and can be taken anywhere without water. The use of OD tablets is expected to improve medication adherence, which results in improved therapeutic performance. Patients who changed from standard tablets to OD tablets have been reported to show improvement of medication adherence and therapeutic efficacy [2, 3]. The patients’ mean (± standard deviation) age was 73.0 ± 8.6 years. Questions 1–3 pertain to the current medication, and questions 4–12 pertain to edoxaban OD tablets

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