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Budesonide Rapidly Induces Clinical Remission in Collagenous Colitis: Presented at UEGW

By Adrian Burton

MADRID, SPAIN -- November 7, 2003 -- German researchers report that budesonide induces rapid clinical remission in patients with collagenous colitis, with most improving after only two weeks of treatment. They discussed their findings here November 5^th at the 11^th United European Gastroenterology Week.

"Collagenous colitis is a chronic inflammatory bowel disease characterized by chronic watery diarrhoea – with maybe [10 bowel movements] per day," explained Ahmed Madisch, MD, fellow in gastroenterology at the University Hospital of Dresden, Germany. The disease can seriously affect quality of life.

Budesonide, a topical corticosteroid with an excellent side effect profile originally developed for managing asthma, has been shown effective in treating this disorder. But in this analysis, the researchers wanted to find out how quickly the drug took effect.

Fifty-one patients (median age, 60 years) with histologically proven collagenous colitis and chronic diarrhoea were enrolled in a randomised, placebo-controlled crossover trial to evaluate oral budesonide 9 mg daily for six weeks. At study entry, the number of watery bowel movements suffered by the patients was between five and 11 per day.

Of 39 patients eligible for assessment, 59% entered clinical remission after only two weeks (i.e., a reduction to three or fewer bowel movements per day). After four weeks, 71.8% entered remission, and after six weeks 84.6% of patients reached the same stage. Compared to crossover results with placebo, the cumulative remission rates at these last two checkpoints were significantly better (P <.001).

The median time to clinical remission was 12 days (range, 2-30 days).

Budesonide 9 mg, therefore, leads to rapid relief from diarrhoea for the majority of collagenous colitis patients -- and in a very short time.

However, to remain in clinical remission requires long-term use of the drug. "About 60% of patients in our analyses get a clinical relapse if you end therapy," said Dr. Madisch. "Therefore, we need a maintenance therapy study, which is already planned. We will be looking at a lower dose, using 6 mg per day, and [test against] a placebo. [Patients will be treated in a healing phase for six weeks] and then go into the maintenance study."

Nonetheless, these are very encouraging results, Dr. Madisch concluded.


[Study title: Time to Clinical Remission in Patients With Collagenous Colitis Treated With Budesonide Capsules – Results From a Randomized, Double-Blind, Placebo-Controlled Trial. Abstract Wed--G-179]

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