Swallowed Budesonide Suspension Treats Eosinophilic Esophagitis in Kids

May 04, 2010

By Karla Gale

NEW YORK (Reuters Health) May 03 - A viscous suspension of budesonide (Pulmicort Respules; AstraZeneca) - mixed with sucrolose (Splenda) and swallowed -- is an effective treatment for eosinophilic esophagitis in children, according to a presentation today in a plenary session at Digestive Disease Week 2010 in New Orleans.

"The data were phenomenal," presenter Dr. Ranjan Dohil told Reuters Health. Eighty-seven percent of children who were randomized into the oral viscous budesonide (OVB) group "responded completely, not only in terms of histology but also in symptoms and endoscopic features."

On the other hand, none of the children in the placebo group had a treatment response.

Dr. Dohil, from the University of California, San Diego, and associates first reported on the potential of OVB several years ago, with data from a small retrospective trial (see Reuters Health report November 16, 2007).

For the 3-month prospective trial reported today, they randomly assigned 24 patients, ages 1 to 17, to receive OVB (n = 15) or placebo (n = 9). Parents prepared OVB by mixing ampules of Pulmicort Respules (0.5 mg budesonide/2 mL) with 10 one-g packets of sucralose per 1 mg budesonide. The once-daily OVB dose was 1 or 2 mg depending on the patient's height (i.e., shorter or taller than five feet).

All children also took the proton pump inhibitor lansoprazole (15 mg twice daily for those under five feet tall; 30 mg twice daily for those who were taller).

Thirteen OVB patients (86.7%) were responders, as defined by a peak eosinophil count of 6 or less per high-power field; one was a partial responder (eosinophil count 7-19).

Eosinophils were significantly reduced in the proximal, middle, and distal esophagus in the OVB group, Dr. Dohil said. Mean symptom and endoscopy scores were significantly improved as well.

Mean pre/post-treatment peak counts were 66.7 and 4.8, respectively, with OVB (p < 0.0001), and 83.9 and 65.6, respectively, with placebo (p = 0.3).

Dr. Dohil said lansoprazole had no effect. "What this is telling us is that eosinophilic esophagitis is not a form of (gastroesophageal reflux disease)," as has been suggested.

He added that he has treated more than 200 patients this way, with no adverse effects observed during therapy lasting as long as 6 years.

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