Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follow-up to 24 months.
BACKGROUND
Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects.


METHODS
An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure.


RESULTS
At 12 months, PPI use was reduced > or =50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQL < or =11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, a > or =50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients.


CONCLUSIONS
This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.
Cohen
Lawrence B
LB
Division of Gastroenterology, Mount Sinai Hospital, New York, New York, USA.
Johnson
David A
DA
Ganz
Robert A
RA
Aisenberg
James
J
Devière
Jacques
J
Foley
T Raymond
TR
Haber
Gregory B
GB
Peters
Jeffrey H
JH
Lehman
Glen A
GA
D001530:Belgium; D002170:Canada; D018795:Device Approval / Q000592:standards; D016145:Endoscopy, Digestive System; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D004869:Equipment Safety; D004947:Esophagus / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D005744:Gastric Acid / Q000378:metabolism; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000378:metabolism / Q000601:surgery*; D006801:Humans; D007391:International Cooperation; D008297:Male; D008365:Manometry; D008875:Middle Aged; D017060:Patient Satisfaction; D011145:Polyvinyls / Q000008:administration & dosage / Q000627:therapeutic use*; D011312:Pressure; D011379:Prognosis; D019736:Prostheses and Implants; D019919:Prosthesis Implantation / Q000295:instrumentation* / Q000523:psychology; D054328:Proton Pump Inhibitors; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D004791:Enzyme Inhibitors; D011145:Polyvinyls; D054328:Proton Pump Inhibitors; C020320:ethylene-vinyl alcohol copolymer