Once daily versus conventional dosing of pH-dependent mesalamine long-term to maintain quiescent ulcerative colitis: Preliminary results from a randomized trial
Sunanda Kane1, William Holderman2, Peter Jacques2, Todd Miodek3
1Mayo Clinic College of Medicine, Rochester, MN, USA; 2Digestive Health Specialists, Tacoma, WA, USA; 3University of Chicago, Chicago, IL, USA
Background and Aims: Multiple studies have demonstrated the efficacy of aminosalicylates in maintaining remission in ulcerative colitis (UC). A newer formulation of mesalamine can be administered once daily. We aimed to examine the efficacy and tolerability of pH-dependent mesalamine for long-term maintenance, and compare the rates of medication consumption between groups over a prolonged period.
Methods: Subjects whose UC had been quiescent for at least 4 months, and who had been receiving mesalamine for maintenance only, were randomized to once daily or conventional dosing for 12 months. Disease activity and medication consumption was assessed every 3 months. The primary endpoint was the percentage of those with quiescent disease at 12 months.
Results: We enrolled 20 patients, 12 to once daily and 8 to conventional dosing. Six of the 12 patients (50%) in the once daily group compared with 5 of the 8 patients (62.5%) in the conventional group experienced a flare (p = 0.31). Only 5 of the 12 (42%) patients in the once daily group were adherent compared with 3 of 8 patients (37.5%) in the conventional dosing group (p = NS). Median amount consumed in the once daily group was 63% (range 0%–100%) and in the conventional group 55% (range 0%–100%), (p > 0.5). None of the adherent subjects in the once daily group experienced a flare, while 6 out of 7 (86%) who were non-adherent experienced a flare (p < 0.01). In the conventional dosing group, 1 in 3 adherent patients (33%) experienced a fl are compared with 4 out of 5 (80%) in the non-adherent group (p < 0.01).
Conclusion: Adherence, rather than medication regimen, appeared to be important in disease outcome at 12 months.
Keywords: ulcerative colitis, mesalamine, aminosalicylates, remission
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF]