Clinical Benefits of Enteryx® for High-Dose PPI Patients

Abstract

Purpose: The primary objective was to evaluate if the effectiveness of Enteryx® is predictable based on the pretreatment dose of proton pump inhibitor (PPI) required to control symptoms. Background: Enteryx® is a biocompatible copolymer designed to help the lower esophageal sphincter (LES) form a more effective reflux barrier to treat gastroesophageal reflux disease (GERD) symptoms. Recent data 12 months post-Enteryx® showed a ≥50% decrease in PPI use or total elimination of PPIs in 80.3% of 81 patients (76.5% of 85 patients, intent to treat), with improvements in health-related quality of life (GERD-HRQL) heartburn and regurgitation scores (Johnson et al., AJG 2003;98: 1921). We investigated whether the clinical benefit at 12 months was related to the baseline PPI dose, dichotomized as standard or high dose. Methods: Analyses were conducted on 117 patients with PPI use and GERD-HRQL symptom score data available at 12 month follow-up visit. Standardized doses were calculated to permit comparisons across different PPIs. Patient data were dichotomized into High Dose and Standard Dose groups. Results: Following Enteryx® treatment at 12 month follow-up, High Dose PPI dependent GERD patients benefited from elimination or ≥50% decrease in PPI use in 88% of patients and benefited from GERD-HRQL symptom score improvement in 72% of patients. In the Standard Dose group the PPI improvement was found in 82% of patients and the GERD-HRQL improvement in 79% of patients. A 2 × 2 contingency table with chi-square analysis determined no significant difference between the 2 groups in terms of PPI use (p=0.461) and symptom score (p=0.406). Conclusions: Following Enteryx®, patients who take High Dose PPIs at baseline experience similar clinical benefits as patients who take Standard Dose PPIs at baseline.