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Enteryx Study

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  • Enteryx Study

    Injectable Copolymer Effective Against GERD

    NEW YORK (Reuters Health) Mar 22 - Augmentation of the lower esophageal sphincter with an injectable copolymer called Enteryx is a useful treatment for gastroesophageal reflux disease (GERD) that can reduce dependency on proton pump inhibitors (PPIs), new research shows.

    Enteryx is a nonviscous liquid that quickly forms a spongy solid after endoscopic injection into the distal esophagus. Eventually, fibrous encapsulation of the implant occurs, which is thought to increase the tone of the lower esophageal sphincter.

    Treatment with Enteryx has shown promise in previous reports, but until now, it had not been compared with a sham procedure, lead author Dr. Jacques Deviere, from Hopital Erasme in Bruxelles, Belgium, and colleagues note.

    The current study involved 64 patients with GERD symptoms that were well controlled with PPI therapy but which rapidly returned upon treatment discontinuation. The subjects were randomized to undergo upper GI endoscopy with or without Enteryx injection. Treatment with Enteryx was offered to all patients who were dissatisfied with their results at 3 months.

    Eighty-one percent of Enteryx-treated patients experience a 50% or greater reduction in PPI use compared with just 53% of controls (p = 0.023), the investigators note. Similarly, 68% of Enteryx-treated patients stopped PPI therapy completely compared with only 41% of controls.

    A 50% or greater improvement in GERD-related quality of life was noted in 67% and 22% of patients in the Enteryx and sham groups, respectively (p < 0.001). Moreover, sham-treated patients were four times more likely to undergo Enteryx treatment at 3 months than were subjects originally treated with the agent.

    Although retrosternal, chest, and epigastric pain as well as dysphagia and odynophagia were initially more common in the Enteryx group, by 6 months the cumulative incidence rates were similar in each group.

    Despite these encouraging results, there are no data indicating that Enteryx treatment or related procedures "are equivalent to or better than medical therapy," Dr. Nicholas J. Shaheen, from the University of North Carolina in Chapel Hill, notes in a related editorial.

    He adds that " given the excellent efficacy and side effect profile of PPIs, until such data do exist, using endoscopic methods interchangeably with medical management in the PPI-responsive patient based solely on patient preference seems imprudent."

    Enteryx is marketed by Boston Scientific Corp, which funded the current study.

    Gastroenterology 2005;128:532-540,781-782.