Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent gastroesophagael reflux disease (GERD).
Dr Cohen and colleagues conducted an open-label, international clinical multi-center trial in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months.
In addition, the researchers assessed the durability and the safety of the treatment for 24 months in 64 patients enrolled in a postapproval study.
|At 12 months, PPI use was eliminated in 73 % of evaluable patients|
The research team’s primary outcome measure was usage of PPI.
Secondary outcomes of the trial were GERD health-related quality of life symptom score and esophageal acid exposure as secondary outcomes.
The team found at 12 months, that PPI use was reduced by 50 % in 84 % of patients and was eliminated in 73 % of evaluable patients.
The investigators observed that a GERD-Health related quality of life score of 11 was attained in 78 % of evaluable patients.
Esophageal acid exposure, measured as the total time of pH higher than 4, was reduced by 31 %.
At 24 months, the researchers noted a 50 % or greater reduction in PPI use in 72 % and PPI use elimination in 67 % of patients.
Dr Cohen’s team concludes ,”This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with 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."