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KMID : 0988920190170010087
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Intestinal Research
2019 Volume.17 No. 1 p.87 ~ p.93
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Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients
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Yagisawa Keiji
Kobayashi Taku
Ozaki Ryo
Okabayashi Shinji
Toyonaga Takahiko
Miura Miki
Hayashida Mari
Saito Eiko
Nakano Masaru
Matsubara Hajime
Hisamatsu Tadakazu
Hibi Toshifumi
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Abstract
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Background/Aims: Oral mesalazine is an important treatment for ulcerative colitis (UC), and non-adherence to mesalazine increases the risk of relapse. Controlled-release (CR) mesalazine has 2 formulations: tablets and granules. The relative acceptabilities of these formulations may influence patient adherence; however, they have not been compared to date. This study aimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossover questionnaire survey.
Methods: UC patients were randomly assigned to 2 groups in a 1:1 ratio. Patients in each group took either 4 g of CR mesalazine tablets or granules for 6 to 9 weeks, and then switched to 4 g of the other formulation for a further 6 to 9 weeks. The acceptability and efficacy were evaluated by questionnaires, and adherence was assessed using a visual analog scale. The difference in acceptabilities between the 2 formulations and its impact on adherence were assessed.
Results: A total of 49 patients were prospectively enrolled and 33 patients were included in the analysis. Significantly more patients found the tablets to be less acceptable than the granules (76% vs. 33%, P=0.0005). The granules were preferable to the tablets when the 2 formulations were compared directly (73% vs. 21%, P=0.004), for their portability, size, and numbers of pills. The adherence rate was slightly better among patients taking the granules (94% vs. 91%) during the observation period, but the difference was not significant (P=0.139).
Conclusions: CR mesalazine granules are more acceptable than tablets, and may therefore be a better option for long-term medication.
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KEYWORD
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Colitis, ulcerative, Mesalamine, Medication adherence, Patient acceptance of health care, Drug compounding
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