Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation

Abstract The efficacy of sustained-release preparations of mesalazine as a remission maintenance treatment for Crohn's disease remains to be established. We aimed to examine the changes in compliance rate and clinical data 2 years after switching from mesalazine tablet to granule formulation at...

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Main Authors: Satoshi Tamura, Natsuki Ishida, Takahiro Miyazu, Shunya Onoue, Shinya Tani, Mihoko Yamade, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Takahisa Furuta, Ken Sugimoto
Format: Article
Language:English
Published: Nature Portfolio 2020-12-01
Series:Scientific Reports
Online Access:https://doi.org/10.1038/s41598-020-78603-9
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author Satoshi Tamura
Natsuki Ishida
Takahiro Miyazu
Shunya Onoue
Shinya Tani
Mihoko Yamade
Yasushi Hamaya
Moriya Iwaizumi
Satoshi Osawa
Takahisa Furuta
Ken Sugimoto
author_facet Satoshi Tamura
Natsuki Ishida
Takahiro Miyazu
Shunya Onoue
Shinya Tani
Mihoko Yamade
Yasushi Hamaya
Moriya Iwaizumi
Satoshi Osawa
Takahisa Furuta
Ken Sugimoto
author_sort Satoshi Tamura
collection DOAJ
description Abstract The efficacy of sustained-release preparations of mesalazine as a remission maintenance treatment for Crohn's disease remains to be established. We aimed to examine the changes in compliance rate and clinical data 2 years after switching from mesalazine tablet to granule formulation at our facility among patients with Crohn's disease in remission. We investigated the rate of continuous treatment of mesalazine granules and examined the changes in Crohn’s Disease Activity Index (CDAI) and serum C-reactive protein (CRP), albumin, and hemoglobin (Hb) levels 2 years after the switch. Compliance rate (continuous treatment vs. additional treatment) and continuous treatment rate [good (rate of ≥ 70%) vs. poor (rate < 70%)] were investigated. Of 46 patients, 12 (27.3%) received additional treatment and 32 (72.7%) did not require additional treatment in 2 years. No significant change in CDAI after switching to granule modification was noted in 32 patients in the continuous treatment group. Nevertheless, clinical remission was maintained for 2 years, and serum CRP levels decreased significantly (P = 0.023) and Hb levels increased significantly (P = 0.002). No change in the compliance rate was found. Our results suggest that mesalazine granule formulation may have a remission maintenance effect that is superior to that of mesalazine tablets.
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spelling doaj.art-51034e09db5b4b42b964b2e511743e392022-12-21T23:00:04ZengNature PortfolioScientific Reports2045-23222020-12-011011810.1038/s41598-020-78603-9Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulationSatoshi Tamura0Natsuki Ishida1Takahiro Miyazu2Shunya Onoue3Shinya Tani4Mihoko Yamade5Yasushi Hamaya6Moriya Iwaizumi7Satoshi Osawa8Takahisa Furuta9Ken Sugimoto10First Department of Medicine, Hamamatsu University School of MedicineFirst Department of Medicine, Hamamatsu University School of MedicineFirst Department of Medicine, Hamamatsu University School of MedicineFirst Department of Medicine, Hamamatsu University School of MedicineFirst Department of Medicine, Hamamatsu University School of MedicineFirst Department of Medicine, Hamamatsu University School of MedicineFirst Department of Medicine, Hamamatsu University School of MedicineDepartment of Laboratory Medicine, Hamamatsu University School of MedicineDepartment of Endoscopic and Photodynamic Medicine, Hamamatsu University School of MedicineCenter for Clinical Research, Hamamatsu University School of MedicineFirst Department of Medicine, Hamamatsu University School of MedicineAbstract The efficacy of sustained-release preparations of mesalazine as a remission maintenance treatment for Crohn's disease remains to be established. We aimed to examine the changes in compliance rate and clinical data 2 years after switching from mesalazine tablet to granule formulation at our facility among patients with Crohn's disease in remission. We investigated the rate of continuous treatment of mesalazine granules and examined the changes in Crohn’s Disease Activity Index (CDAI) and serum C-reactive protein (CRP), albumin, and hemoglobin (Hb) levels 2 years after the switch. Compliance rate (continuous treatment vs. additional treatment) and continuous treatment rate [good (rate of ≥ 70%) vs. poor (rate < 70%)] were investigated. Of 46 patients, 12 (27.3%) received additional treatment and 32 (72.7%) did not require additional treatment in 2 years. No significant change in CDAI after switching to granule modification was noted in 32 patients in the continuous treatment group. Nevertheless, clinical remission was maintained for 2 years, and serum CRP levels decreased significantly (P = 0.023) and Hb levels increased significantly (P = 0.002). No change in the compliance rate was found. Our results suggest that mesalazine granule formulation may have a remission maintenance effect that is superior to that of mesalazine tablets.https://doi.org/10.1038/s41598-020-78603-9
spellingShingle Satoshi Tamura
Natsuki Ishida
Takahiro Miyazu
Shunya Onoue
Shinya Tani
Mihoko Yamade
Yasushi Hamaya
Moriya Iwaizumi
Satoshi Osawa
Takahisa Furuta
Ken Sugimoto
Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
Scientific Reports
title Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
title_full Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
title_fullStr Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
title_full_unstemmed Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
title_short Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
title_sort mesalazine granule formulation improves clinical data in crohn s disease compared with tablet formulation
url https://doi.org/10.1038/s41598-020-78603-9
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