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Improved pH-Metry and Symptom Scores 3 mo Post-ENTERYX®

Interim US Randomized Controlled Trial Results


Rothstein, Richard I., M.D.; Chen, Yang K., M.D.; Mendolia, Thomas F., DO; Cohen, Lawrence B., M.D.; Deviere, Jacques, M.D.; Foley, T. Raymond, M.D.; Johnson, David A., M.D.; Costamagna, Guido, M.D.; Fennerty, M. Brian, M.D.; Sharma, Prateek, M.D.; Snape, William Jr., M.D.; Edmundowicz, Steven A., M.D.; Lehman, Glen A., M.D.; Kahrilas, Peter J., M.D.

American Journal of Gastroenterology: September 2005 - Volume 100 - Issue - p S47
Supplement Abstracts Submitted for the 70th Annual Scientific Meeting of the American College of Gastroenterology: ESOPHAGUS

Dept. Gastro., Dartmouth-Hitchcock Medical Center, Lebanon, NH; U. Colorado Hospital, Aurora, CO; NW Piedmont Clinical Research, Elkin, NC; Mt. Sinai Hospital, New York, NY; Erasme Hospital, Brussels, Belgium; Regional Gastroenterology Associates, Lancaster, PA; Eastern VA School of Medicine, Norfolk, VA; U. Cattolica del Sacro Cuore, Rome, Italy; Oregon Health Sciences U., Portland, OR; VA Medical Center, Kansas City, MO; CA Pacific Medical Center, San Francisco, CA; Washington U., St. Louis, MO; Indiana U. Medical Center, Indianapolis, IN and Northwestern U., Chicago, IL,.

Purpose: To compare pH-metry and GERD-HRQL scores in ENTERYX treated (EG) vs control (CG) groups.

Methods: PPI-dependent and responsive pts were randomized to either EG or CG. CG pts underwent endoscopy; DMSO was sprayed on distal esophagus. 3 mo post initial procedure, EG pts w/ GERD-HRQL score >11 (off PPIs) were eligible for retreatment; CG pts who were off PPIs with GERD-HRQL ≥20 and pH<4.0 for >5% of total time were eligible for crossover to ENTERYX. pH-metry success was defined as either total time pH ≤4.0 for ≤5% or total time pH ≤4.0 reduced ≥50% from baseline. GERD-HRQL score success was defined as either a score of ≤11 or an improvement from baseline ≥9 points.

Results: Interim 3-mo data were available for 62 pts (31/group). To date, 61% (19/31) of CG pts crossed over and 13% (4/31) of EG pts were retreated. These initial results reflect outcomes from one ENTERYX treatment. Mean change from baseline (CFB) in pH-metry (% total time pH ≤ 4.0) was −4.3% in EG, vs −0.5% in CG (p < 0.05). pH-metry success was achieved by 50% of EG vs 23% of CG (p < 0.05). EG had more patients achieve GERD-HRQL heartburn score success (83% vs 54%, p < 0.05) and had larger mean CFB for GERD-HRQL heartburn (−14.9 vs −9.2, p < 0.05) than the CG.

Conclusions: At 3 mo, ENTERYX Procedure significantly improves pH-metry and GERD-HRQL measures vs control. Furthermore, the proportion of pts eligible for retreatment/crossover was lower in the ENTERYX group than in controls, despite similar eligibility criteria. These results confirm the true effect of ENTERYX in the treatment of GERD.

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