Long-term follow-up of collagenous colitis after induction of clinical remission with budesonide

TY - JOUR

T1 - Long-term follow-up of collagenous colitis after induction of clinical remission with budesonide

AU - Miehlke, S

AU - Madisch, A

AU - Voss, C

AU - Morgner, A

AU - Heymer, P

AU - Kuhlisch, E

AU - Bethke, B

AU - Stolte, M

PY - 2005/12

Y1 - 2005/12

N2 - BACKGROUND: Budesonide (Entocort) is effective for the treatment of collagenous colitis.AIM: To assess the long-term outcome of patients after induction of clinical remission by budesonide treatment.METHODS: Fifty-one patients with chronic diarrhoea and histologically proven collagenous colitis were enrolled in randomized, placebo-controlled crossover trial using budesonide 9 mg daily for 6 weeks. Patients in clinical remission after either initial or crossover budesonide treatment were followed using standardized questionnaires. Clinical relapse was defined as five or more loose stools/day for at least 4 consecutive days.RESULTS: A total of 33 patients achieved clinical remission (85% per-protocol). During a median follow-up of 16 months, clinical relapse occurred in 20 patients (61%), after a median time of 2 weeks (range: 1-104, mean: 10 weeks). Patient age <60 years was identified as a significant risk factor for clinical relapse (OR = 7.4, P = 0.048). Budesonide was used for treatment of clinical relapse in 80% of patients achieving clinical response in all of them.CONCLUSIONS: Budesonide is effective in the treatment of collagenous colitis. Clinical relapses may occur in a considerable number of patients, particularly in those <60 years. Treatment of clinical relapse with budesonide appears to be an effective option.

AB - BACKGROUND: Budesonide (Entocort) is effective for the treatment of collagenous colitis.AIM: To assess the long-term outcome of patients after induction of clinical remission by budesonide treatment.METHODS: Fifty-one patients with chronic diarrhoea and histologically proven collagenous colitis were enrolled in randomized, placebo-controlled crossover trial using budesonide 9 mg daily for 6 weeks. Patients in clinical remission after either initial or crossover budesonide treatment were followed using standardized questionnaires. Clinical relapse was defined as five or more loose stools/day for at least 4 consecutive days.RESULTS: A total of 33 patients achieved clinical remission (85% per-protocol). During a median follow-up of 16 months, clinical relapse occurred in 20 patients (61%), after a median time of 2 weeks (range: 1-104, mean: 10 weeks). Patient age <60 years was identified as a significant risk factor for clinical relapse (OR = 7.4, P = 0.048). Budesonide was used for treatment of clinical relapse in 80% of patients achieving clinical response in all of them.CONCLUSIONS: Budesonide is effective in the treatment of collagenous colitis. Clinical relapses may occur in a considerable number of patients, particularly in those <60 years. Treatment of clinical relapse with budesonide appears to be an effective option.

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Anti-Inflammatory Agents

KW - Budesonide

KW - Colitis, Collagenous

KW - Cross-Over Studies

KW - Diarrhea

KW - Double-Blind Method

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Male

KW - Middle Aged

KW - Treatment Outcome

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1111/j.1365-2036.2005.02688.x

DO - 10.1111/j.1365-2036.2005.02688.x

M3 - SCORING: Journal article

C2 - 16305725

VL - 22

SP - 1115

EP - 1119

JO - ALIMENT PHARM THER

JF - ALIMENT PHARM THER

SN - 0269-2813

IS - 11-12

ER -