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Patient‐led variable dosing with balsalazide as long‐term therapy for maintenance in ulcerative colitis: a 3‐year prospective observational study
Author(s) -
Green J. R. B.,
Swan C. H. J.,
Gibson J. A.,
Kerr G. D.,
Swarbrick E. T.,
Thornton P. C.
Publication year - 2004
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2004.01866.x
Subject(s) - medicine , ulcerative colitis , cohort , dosing , maintenance therapy , colitis , prospective cohort study , cohort study , gastroenterology , surgery , chemotherapy , disease
Summary Background : The patient‐centred approach is new to the management of ulcerative colitis. To date, it has only been shown to be successful in a short‐term study. Aim : To assess the feasibility, safety and efficacy of patient‐led dosing using balsalazide in the long‐term treatment of ulcerative colitis. Methods : This was a 3‐year, two‐cohort, multi‐centre study: one cohort was in stable remission (52 patients) and the other was newly in remission (76 patients) from ulcerative colitis. Two 750‐mg balsalazide capsules were given twice daily for maintenance, increased by 750‐mg increments to a maximum of 6 g for up to 7 days depending on symptom severity. Clinical assessments were made every 12–14 weeks; laboratory assessments were made every 6 months. Results : The average median daily dose of balsalazide was 3 g (range, 1.5–6 g). In the cohort with stable remission, 23 patients (44%) had relapsed by 3 years [median time to relapse, > 1095 days (36 months)]. In the cohort newly in remission, these values were 45 patients (59%) and 656 days (22 months), respectively. In the cohort with stable remission, the time since last relapse was significantly associated with relapse during the first year of treatment ( P < 0.033). Conclusions : Long‐term, patient‐led, maintenance treatment with balsalazide is well tolerated with a good safety profile and is effective for patients with ulcerative colitis.