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Enteryx Safe and Efficacious Alternative to Proton Pump Inhibitors for Gastro-oesophageal Reflux Disease: Presented at UEGW

By Chris Berrie

PRAGUE, CZECH REPUBLIC -- September 28, 2004 -- Enteryx™, an endoscopically injected, tantalum-marked, biocompatible, co-polymer, appears to have safety and performance profiles that make it a suitable first-line alternative to surgery and to long-term proton-pump inhibitor (PPI) use in patients with gastro-oesophageal reflux disease (GORD).

This conclusion, from a European multicentre study, was presented here September 27th at the 12th United European Gastroenterology Week.

Dr. Brigitte Schumacher, MD, study coordinator and leader, endoscopy department, Medizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany, presented this study on behalf of the European Enteryx EFS Investigators Group.

The study's aim was to determine if injection of Enteryx in dimethyl sulfoxide under fluoroscopic guidance into the deep muscular layers of the lower oesophageal sphincter could provide an alternative treatment for patients who have GORD.

The researchers enrolled 93 PPI-dependent patients with symptomatic GORD and a mean age of 48 years; 68.5% were men, and they received a mean pre-PPI treatment of 17 months. Patients were enrolled if they had a Velanovich GORD-HRQL score of 11 or less while on PPI therapy that was accompanied by recurrent symptoms and a score increase to 20 or greater when off PPI therapy.

Exclusion criteria included grade 3/4 erosive esophagitis, oesophageal motility disorder, oesophageal/gastric varices, prior gastric or GORD surgery, hiatal hernia of 3 cm or larger, or Barrett's oesophagus.

After a 10-day PPI-free period, patients received Enteryx treatment and could receive a second treatment if they did not respond within 3 months after the first treatment. A second dose was required by 6.5% of patients. Patients were followed for 12 months. Assessments of PPI use, adverse events, quality of life (SF-36) and regurgitation (GORD-HRQL) were made at each visit. The main assessment criterion for treatment success was 50% or greater reduction in PPI use.

At baseline, 12.9% of patients taking half of the standard PPI dose, 68.8% were taking the standard dose, and 18.3% were on twice the standard dose. At 6 months and 12 months postprocedure, 67.1% and 64.9% of patients, respectively, had discontinued their PPI treatment, and 18.3% and 21.6% had reduced their consumption by at least 50%.

A distinct and significant improvement of 69% was seen in the GORD-HRQL scores at 6 months and 12 months, which at 12 months included heartburn (P <.0001) and regurgitation (P <.0005). There were also significant improvements in the physical (P <.0001) and mental (P <.0012) quality of life scores at 12 months, as well as improvements in the pH levels and manometry results.

There were no deaths or life-threatening events, although a few patients had worsening of esophagitis (32.8%), which the researchers noted could also be seen under prolonged PPI treatment. The main device-related adverse events were mild transient retrosternal chest or epigastric pain (77.4%), dysphasia/odynophagia (26.9%) and fever sensation (25.8%).

Dr. Schumacher emphasised that these indications of Enteryx as an alternative treatment to surgery and long-term PPI use in these GORD patients were also in line with observations from a similarly designed study conducted in the United States (Am J Gastroenterol. 2003 Sep;98(9):1921-1930).


[Presentation title: "Enteryx™: A Safe and Efficacious Alternative to PPI Treatment for GORD. Abstract MON-G-173." Abstract 483])

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