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Budesonide effective first-line treatment for lymphocytic colitis
Oral budesonide was safe and effective as a first-line treatment for lymphocytic colitis, according to research published in Gastroenterology.
Stephen Miehlke, MD, of the Center for Digestive Diseases at Internal Medicine Center Eppendorf in Hamburg, Germany, and colleagues also found that another potential treatment, mesalazine, was not significantly better than placebo at inducing clinical or histologic remission.
Both drugs are recommended treatments for microscopic colitis, but research on their use in lymphocytic colitis has been limited, researchers wrote.
“A recent Cochrane review concluded that budesonide may be an effective therapy for treatment of lymphocytic colitis,” they wrote. “The evidence to support this statement is of low quality and further randomized, placebo-controlled trials studying interventions for lymphocytic colitis are warranted.”
Miehlke and colleagues conducted a randomized, double-blind, double-dummy trial comprising 57 patients with lymphocytic colitis (72% female; mean age, 59 years). The primary endpoint was clinical remission defined as no more than 21 stools — including no more than six watery stools — in the 7 days before week 8 of the study.
Investigators randomly assigned patients to 9 mg budesonide, 3 g mesalazine or placebo once daily for 8 weeks (all groups, n = 19).
Researchers found that a higher percentage of patients in the budesonide group achieved clinical remission compared with the placebo group (78.9% vs. 42.1%; P = .01). Although 63.2% of patients in the mesalazine group achieved the primary endpoint, the difference in clinical remission compared with placebo was not statistically significant.
Miehlke and colleagues also determined that the median time to remission was lower in the budesonide group compared with the placebo group (3 days vs. 21 days; P = .044).
The proportion of patients with histologic remission after 8 weeks was higher in the budesonide group (68%) than both the mesalazine (26%; P = .02) and placebo groups (21%; P = .008).
According to the researchers, their findings show that budesonide is effective for the induction of remission in active lymphocytic colitis.
“This trial addressed the need for well-designed trials to assess the efficacy of budesonide in treating active lymphocytic colitis,” they wrote. “These results confirm the efficacy of budesonide for the induction of remission in active lymphocytic colitis and are consistent with expert recommendations for its use as first-line therapy.” – by Alex Young
Disclosures: Miehlke reports he has received speaking fees from Dr. Falk Pharma and consultant fees from Tillots. Please see the study for all other authors’ relevant financial disclosures.