Enteryx Implant Helpful in GERD

Laurie Barclay, MD

February 24, 2003

Editor's Note: On October 17, 2005, an alert from MedWatch, the US Food and Drug Administration's safety information and adverse event reporting program, advised physicians to cease use of Enteryx immediately due to serious adverse events. To read the alert, click here.

Feb. 24, 2003 — Enteryx, a biocompatible nonbiodegradable liquid polymer, is effective in the treatment of intractable gastroesophageal reflux disease (GERD), according to the results of a six-month study published in the February issue of the American Journal of Gastroenterology.

"The findings from this clinical study suggest that endoscopic treatment of GERD by Enteryx implantation may offer a viable alternative to lifelong proton pump inhibitor (PPI) use without the risks associated with antireflux surgery," write David A. Johnson, MD, from the Eastern Virginia School of Medicine in Norfolk, and colleagues.

Study enrollment criteria for 85 patients with heartburn symptoms reponsive to PPI were GERD-Health-Related Quality of Life (GERD-HRQL) score of 11 or less while receiving a PPI and 20 or greater while not receiving a PPI, and pH of 4 or less for at least 5% of the time on 24-hour pH probe. Exclusion criteria were hiatus hernia larger than 3 cm, grade 3 or 4 esophagitis, and esophageal motility disorder.

During standard endoscopy, Enteryx was implanted in three or four quadrants of the wall of the cardia. Although some patients experienced transient, mild to moderate chest pain after implantation, there were no clinically serious adverse events. Mean length of the lower esophageal sphincter increased from 2.0 cm at baseline to 3.0 cm after implantation ( P = .003).

At six months, median GERD-HRQL score improved from 24.0 at baseline for those not receiving a PPI to 4.0 ( P < .001); mean total esophageal acid exposure time decreased from 9.5% before implantation to 6.7% ( P < .001). PPI use was discontinued in 74% of patients and reduced by at least half in 10%.

"The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD," the authors write. "Further studies of the long-term efficacy and durability, and its cost-effectiveness relative to alternative GERD treatments are in progress."

Am J Gastroenterol. 2003;98:250-258

Reviewed by Gary D. Vogin, MD