Long-term budesonide treatment of collagenous colitis: a randomised, double-blind, placebo-controlled trial.
OBJECTIVE
To evaluate the efficacy and safety of long-term budesonide therapy for the maintenance of clinical remission in patients with collagenous colitis.


METHODS
Randomised, placebo-controlled study with a 24-week, blinded follow-up period without any treatment.


METHODS
Three gastroenterology clinics in Denmark.


METHODS
Forty-two patients with histologically confirmed collagenous colitis and diarrhoea (more than three stools/day).


METHODS
Patients in clinical remission after 6 weeks' open-label therapy with oral budesonide (Entocort CIR capsules, 9 mg/day) received 24 weeks' double-blind maintenance therapy with budesonide 6 mg/day or placebo. Thereafter, patients entered the 24-week, blinded follow-up period.


METHODS
The proportion of patients in clinical remission (three or fewer stools/day) at the end of maintenance therapy.


RESULTS
A total of 34 patients in remission at week 6 were randomly assigned to budesonide 6 mg/day (n = 17) or placebo (n = 17). After 24 weeks' maintenance treatment, the proportions of patients in clinical remission were 76.5% (13 of 17) with budesonide and 12% (2 of 17) with placebo (p<0.001). At 48 weeks (the end of the follow-up period, without any treatment) these values were 23.5% (4 of 17) and 12% (2 of 17), respectively (p = 0.6). The median times to relapse after stopping active treatment (6 plus 24 weeks in the budesonide group; 6 weeks in the placebo group) were 39 and 38 days, respectively. Long-term treatment with budesonide was well tolerated.


CONCLUSIONS
Long-term maintenance therapy with oral budesonide is efficacious and well tolerated for preventing relapse in patients with collagenous colitis. The risk of relapse after 24 weeks' maintenance treatment is similar to that observed after 6 weeks' induction therapy.
Bonderup
O K
OK
Department of Internal Medicine, Randers Regional Hospital, Skovlyvej 1, Randers, Denmark. obo@rc.aaa.dk
Hansen
J B
JB
Teglbjaerg
P S
PS
Christensen
L A
LA
Fallingborg
J F
JF
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D046729:Colitis, Collagenous / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004812:Epidemiologic Methods; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D019819:Budesonide