Intest Res.  2019 Jul;17(3):349-356. 10.5217/ir.2018.00064.

Adherence to Asacol once daily versus divided regimen for maintenance therapy in ulcerative colitis: a prospective, multicenter, randomized study

Affiliations
  • 1Division of Gastroenterology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. diksmc.park@samsung.com
  • 2Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 3Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.
  • 4Department of Internal Medicine, Digestive Disease Research Institute, Wonkwang University Hospital, Wonkwang University College of Medicine, Iksan, Korea.
  • 5Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
  • 6Division of Gastroenterology, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.

Abstract

BACKGROUND/AIMS
A once-daily (OD) regimen of 5-aminosalicylic acid (5-ASA) was easier to comply with than a divided daily (DD) regimen, and that treatment efficacy for ulcerative colitis (UC) was not affected by the dosing regimen. This study evaluated treatment adherence of OD and DD dosing in the Korean UC patients.
METHODS
This study was a prospective, multicenter, randomized trial. UC patients were enrolled who have been in remission for more than 3 months. Patients were randomly assigned to the OD or DD group in a 1:1 ratio. The primary endpoint was adherence rate measured by tablet counts and self-reported adherence rate at 3, 6, 9, and 12 months. The relapse rate was measured at 1 year.
RESULTS
Data from the 180 patients who were randomized were analyzed. Both self-reported adherence rate and adherence rate measured by tablet counts were not different at every points, including 1 year. The patients' satisfaction of the OD group was higher than that of the DD group (P<0.001). At 1 year, 91.2% and 95.5% of patients in the OD group and DD group had maintained clinical remission, respectively (P=0.37).
CONCLUSIONS
The adherence rates were not different between the OD group and DD group. The patients' satisfaction was higher in the OD group than in the DD group. 5-ASA OD dosing might have the same effect as DD for the maintenance of UC remission.

Keyword

Colitis, ulcerative; Mesalamine; Inflammatory bowel disease

MeSH Terms

Colitis, Ulcerative*
Humans
Inflammatory Bowel Diseases
Mesalamine*
Prospective Studies*
Recurrence
Treatment Outcome
Ulcer*
Mesalamine

Figure

  • Fig. 1. Patient enrollment and follow-up during the trial. OD, once daily; DD, divided daily.

  • Fig. 2. Proportion of patients whose adherence was lower than 90%. (A) Self-reported adherence. (B) Adherence measured by tablet counts in the once daily (OD) group versus the divided daily (DD) group.


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