Yamashita Takeshi, Hagii Joji, Morishima Yoshiyuki, Akasaka Takaaki, Matsumoto Takuyuki, Kimura Tetsuya
1The Cardiovascular Institute, 3-2-19, Nishiazabu, Minato-ku, Tokyo 106-0031 Japan.
Hirosaki Stroke and Rehabilitation Center, 1-2-1, Ougi-machi, Hirosaki, Aomori 036-8104 Japan.
Thromb J. 2019 Feb 15;17:3. doi: 10.1186/s12959-019-0192-x. eCollection 2019.
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.
Edoxaban 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).
In 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.
This 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.
UMIN-CTR UMIN000028788, registered 23-Aug-2017.
本研究对非瓣膜性心房颤动患者口服依度沙班口腔崩解片（OD片）进行了感官评价，这些患者在研究前一直在服用现有的依度沙班薄膜包衣片。
为研究前一直在服用30毫克或60毫克依度沙班薄膜包衣片的患者开具30毫克或60毫克的依度沙班OD片。每个剂量组被随机分为用水服用和不用水服用片剂的组。在摄入依度沙班OD片后，要求每位患者完成一份感官评价问卷（12项）。
在对依度沙班OD片的满意度评价中，52.8%的患者认为与现有的依度沙班薄膜包衣片“无差异”，34.9%的患者表示对OD片更满意，因此显示出较高的满意度。当被问及使用依度沙班OD片的便利性和可靠性时，约一半的患者认为与现有的依度沙班薄膜包衣片“无差异”，其余一半表示更喜欢OD片。关于味道、气味、吞咽 ease和继续服用依度沙班的意愿的回答表明患者对OD片总体接受。约一半的患者将依度沙班OD片的识别评为“容易”，其余一半评为“困难”。在所有患者中，49.5%的患者更喜欢改用依度沙班OD片。当OD片用水服用而非不用水服用时，对味道、气味和吞咽 ease的满意度以及总体满意度往往更高，并且在用水服用OD片的组中更喜欢改用的患者百分比更高。
本研究表明，与现有的依度沙班薄膜包衣片相比，OD片在味道、气味、吞咽 ease、便利性以及总体满意度方面，以及在继续服药的意愿和信心方面的满意度更高。依度沙班OD片是一种有前景的剂型，可促使患者更好地坚持用药，从而确保更好的治疗反应。
UMIN-CTR UMIN000028788，于2017年8月23日注册。
