Source: J Clin Otorhinolaryngol  |  Posted 7 years ago

By Mike Fillon

ORLANDO, FL -- November 5, 2004 -- Endoscopic implantation of Enteryx achieves relief of gastroesophageal reflux disease (GERD) symptoms and possibly could do away with daily drug therapy, according to the first placebo-controlled study of the procedure.

Results of the study were displayed in a poster presentation here on November 2nd at the American College of Gastroenterology 69th Annual Scientific Meeting, held October 29th to November 3rd.

The multicenter, placebo-controlled clinical trial enrolled 64 patients with heartburn and regurgitation who were dependent on proton pump inhibitor (PPI) therapy. Of these, 32 were randomly assigned to undergo the Enteryx Procedure, and 32 were assigned to the control group, consisting only of an esophagogastroduodenoscopy (EGD) procedure. The primary endpoint was PPI use at 3 months; secondary endpoints included GERD Health-related Quality of Life (GERD-HRQL) symptom score, 24 hr pH-metry, and manometry.

According to lead investigator, Jacques Devi?re, MD, gastroenterologist at H?pital Erasme, Universit? Libre de Bruxelles, Brussels, Belgium, results showed that at 3 months, 68% of patients in the Enteryx group eliminated their daily use of PPIs compared with 41% of patients in the control group (P <.05).

Median improvement from baseline in GERD-HRQL was 15 (range 7 to 23) in the Enteryx group compared to 4 (range -4 to 13) in the control group. Also, 63% of Enteryx patients had completely eliminated daily use of PPIs compared to 33% of controls.

"The data from this study provides preliminary evidence that the effectiveness of the Enteryx Procedure observed in previously reported unblinded, prospective clinical trials reflects actual improvement in symptom relief and is not a placebo effect," Dr. Devi?re said (Am J Gastroenterol. 2003 Sep;98(9):1921-30). "This data indicates that the Enteryx Procedure could provide GERD patients with an effective approach to addressing the symptoms of their disease."

Enteryx is an 8% ethylene vinyl alcohol copolymer dissolved in dimethyl sulfoxide that has been approved for the treatment of GERD. The Enteryx procedure can be performed as a minimally invasive treatment on an outpatient basis. The product is injected into the muscle of the lower esophageal sphincter (LES) through an endoscope, forming a sponge-like permanent implant in the sphincter muscle. It is intended to reduce the symptoms of GERD by helping the LES keep stomach fluids and acids from backing up into the esophagus. It does not affect the stomach's ability to produce acid or other digestive fluids.

Boston Scientific Corporation provided funding for the study.

[Presentation title: Endoscopic Implantation of Enteryx? for the Treatment of GERD: a Randomized Controlled Trial. Abstract 772]