Background: There are limited data about the long-term follow-up of patients with ulcerative colitis (UC) maintained on high versus low doses of mesalamine. We evaluated the best long-term average daily dose that would keep the disease in remission.
Methods: Nationwide ulcerative colitis data were obtained from the Veterans Affairs health care system for the period 2001 to 2011. Those who started mesalamine maintenance during this period were included. Average daily dose and the level of adherence were assessed for the period between the first mesalamine dispense and the date of first flare defined as the first filling of 40 mg/day or more of oral prednisone or any dose of intravenous steroids. Patients with ulcerative colitis maintained on an average daily dose 2.4 to 2.8 g/day (low dose) were compared with 4.4 to 4.8 g/day (high dose). Adherence was assessed using continuous single interval medication availability indicator.
Results: We included 4452 patients with a median follow-up of 6 years. There was no significant reduction in the risk of flares when comparing high versus low average mesalamine dose among patients with high [hazard ratio = 0.96, P = 0.8)] and medium (hazard ratio = 0.74, P = 0.17) adherence. However, there was a significant reduction in the risk of flares with high dose of mesalamine among patients with low adherence (hazard ratio = 0.28, P = 0.003).
Conclusions: Our data show that when starting a patient on mesalamine, there is no difference in the long-term flare risk between low versus high average daily dose as long as the patients have a high to moderate level of adherence.
Article first published online 19 March 2013
*Department of Internal Medicine, Section of Gastroenterology, Southeast Louisiana Veterans Health Care System;
†Department of Internal Medicine, Section of Gastroenterology and Hepatology, Tulane University Health Sciences Center; and
‡Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.
The authors have no conflicts of interest to disclose.
Reprints: Nabeel Khan, MD, Tulane University School of Medicine, 1430 Tulane Avenue, SL35, New Orleans, LA 70112 (e-mail: email@example.com, firstname.lastname@example.org).
Supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development (R&D) Health Services.
Study sponsor had no role in study design, analysis, interpretation and in report writing. The contents of this report do not represent the views of the Department of Veterans Affairs or the United States Government.
Received August 17, 2012
Accepted August 20, 2012