Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients.
Colitis, ulcerative
Drug compounding
Medication adherence
Mesalamine
Patient acceptance of health care
Journal
Intestinal research
ISSN: 1598-9100
Titre abrégé: Intest Res
Pays: Korea (South)
ID NLM: 101572802
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
31
05
2018
accepted:
06
10
2018
pubmed:
14
12
2018
medline:
14
12
2018
entrez:
14
12
2018
Statut:
ppublish
Résumé
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. 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. 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). CR mesalazine granules are more acceptable than tablets, and may therefore be a better option for long-term medication.
Sections du résumé
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.
Identifiants
pubmed: 30541227
pii: ir.2018.00078
doi: 10.5217/ir.2018.00078
pmc: PMC6361024
doi:
Types de publication
Journal Article
Langues
eng
Pagination
87-93Commentaires et corrections
Type : ErratumIn
Références
Aliment Pharmacol Ther. 2000 Feb;14(2):163-9
pubmed: 10651656
Am J Med. 2003 Jan;114(1):39-43
pubmed: 12543288
Am J Ther. 2007 Mar-Apr;14(2):221-5
pubmed: 17414593
Am J Gastroenterol. 2011 Dec;106(12):2070-7; quiz 2078
pubmed: 21894226
Gastroenterol Nurs. 2012 Jan-Feb;35(1):24-31
pubmed: 22306727
J Gastroenterol. 2013 Sep;48(9):1006-15
pubmed: 23208019
Aliment Pharmacol Ther. 2013 Apr;37(8):767-75
pubmed: 23451806
Clin Infect Dis. 2014 May;58(9):1297-307
pubmed: 24457345
J Manag Care Spec Pharm. 2014 Mar;20(3):309-14
pubmed: 24564811
Inflamm Bowel Dis. 2016 Sep;22(9):2158-64
pubmed: 27482979
J Crohns Colitis. 2017 Jun 1;11(6):649-670
pubmed: 28158501
Eur Heart J Suppl. 2016 Apr 20;18(Suppl D):D1-D6
pubmed: 28533706
Am J Gastroenterol. 1993 Aug;88(8):1188-97
pubmed: 8338086