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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.

AbstractBACKGROUND:
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.
AuthorsJ R B Green, C H J Swan, J A Gibson, G D Kerr, E T Swarbrick, P C Thornton
JournalAlimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 19 Issue 4 Pg. 435-42 (Feb 15 2004) ISSN: 0269-2813 [Print] England
PMID14871283 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Aminosalicylic Acids
  • Phenylhydrazines
  • Mesalamine
  • balsalazide
Topics
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Aminosalicylic Acids (administration & dosage, adverse effects)
  • Cohort Studies
  • Colitis, Ulcerative (drug therapy)
  • Female
  • Humans
  • Male
  • Mesalamine
  • Middle Aged
  • Patient Participation
  • Phenylhydrazines
  • Prognosis
  • Prospective Studies
  • Recurrence
  • Treatment Outcome

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