Safety and Efficacy of Enteryx for Treatment of GERD in Patients with GERD and Asthma: A Pilot Study

Abstract

Enteryx™, a non-resorbing biocompatible polymer has been shown to facilitate the reduction or discontinuation of proton pump inhibitor (PPI) therapy in patients with chronic gastroesophageal reflux disease (GERD). There appears to be a strong association between GERD and asthma. Up to 45% of asthmatic patients experience at least one episode of symptomatic GERD per week vs. only 10% of non-asthmatic controls. In carefully selected patients with GERD and asthma, medical and surgical treatments have been shown to control GERD and in some cases improve asthma symptoms. The primary aim of this study was to evaluate the safety and efficacy of Enteryx™ in patients with GERD and asthma. Methods: 52 patients with GERD and asthma were identified in our Asthma Clinic. All patients were taking maintenance PPI therapy. Ten agreed to participate in the study. Bravo™ pH monitoring was performed in all ten. Eight had positive pH testing, defined as a DeMeester Score of > 14.7. Six agreed to participate, one was excluded at the principal investigator's (PI's) discretion. All procedures were performed by the PI. Enteryx™ was injected into the muscular layer of the esophagus under fluoroscopic guidance at or 1 cm below the z-line. 1cc minimum aliquots were placed with each injection. An average of 5.88 cc (range 3.7-7.2) of Enteryx™ was injected during each session. All patients received sedation with propofol administered by an anesthesiologist or nurse anesthetist. There were no serious adverse events associated with the procedure or the sedation. Mean procedure time was 38 minutes. Standardized health-related quality of life questionnaires (HRQL) for GERD and for asthma along with medication use were measured before implantation and at 1, 2, and 4 weeks after the procedure. Results: At week 4 a statistically significant (p < 0.05) improvement in HRQL for both GERD and asthma was demonstrated following the Enteryx™ procedures. A trend toward linear relationship between GERD and asthma HRQL was also noted. Conclusion: Based on the interim analysis of our data the Enteryx™ procedure appears to be safe and effective in carefully selected patients with GERD and asthma. A statistically significant improvement in both GERD and asthma HRQL scores was demonstrated. Moreover, a trend toward a direct relationship between the improvement in GERD HRQL and asthma HRQL scores was seen. Enrollment continues, we await the 6 and 12-month follow-up data to confirm our initial results. Enteryx™, a non-resorbing biocompatible polymer has been shown to facilitate the reduction or discontinuation of proton pump inhibitor (PPI) therapy in patients with chronic gastroesophageal reflux disease (GERD). There appears to be a strong association between GERD and asthma. Up to 45% of asthmatic patients experience at least one episode of symptomatic GERD per week vs. only 10% of non-asthmatic controls. In carefully selected patients with GERD and asthma, medical and surgical treatments have been shown to control GERD and in some cases improve asthma symptoms. The primary aim of this study was to evaluate the safety and efficacy of Enteryx™ in patients with GERD and asthma. Methods: 52 patients with GERD and asthma were identified in our Asthma Clinic. All patients were taking maintenance PPI therapy. Ten agreed to participate in the study. Bravo™ pH monitoring was performed in all ten. Eight had positive pH testing, defined as a DeMeester Score of > 14.7. Six agreed to participate, one was excluded at the principal investigator's (PI's) discretion. All procedures were performed by the PI. Enteryx™ was injected into the muscular layer of the esophagus under fluoroscopic guidance at or 1 cm below the z-line. 1cc minimum aliquots were placed with each injection. An average of 5.88 cc (range 3.7-7.2) of Enteryx™ was injected during each session. All patients received sedation with propofol administered by an anesthesiologist or nurse anesthetist. There were no serious adverse events associated with the procedure or the sedation. Mean procedure time was 38 minutes. Standardized health-related quality of life questionnaires (HRQL) for GERD and for asthma along with medication use were measured before implantation and at 1, 2, and 4 weeks after the procedure. Results: At week 4 a statistically significant (p < 0.05) improvement in HRQL for both GERD and asthma was demonstrated following the Enteryx™ procedures. A trend toward linear relationship between GERD and asthma HRQL was also noted. Conclusion: Based on the interim analysis of our data the Enteryx™ procedure appears to be safe and effective in carefully selected patients with GERD and asthma. A statistically significant improvement in both GERD and asthma HRQL scores was demonstrated. Moreover, a trend toward a direct relationship between the improvement in GERD HRQL and asthma HRQL scores was seen. Enrollment continues, we await the 6 and 12-month follow-up data to confirm our initial results.