Health Economic Data for TIF Procedure Also Highlighted
REDMOND, Washington – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced updated one-year clinical data from the RESPECT (Randomized EsophyX® vs. Sham/Placebo Controlled Trial) study, the first-ever randomized, blinded, sham- and placebo-controlled study of the company’s Transoral Incisionless Fundoplication (TIF®) procedure. The RESPECT study, along with a second separate study of health economic data comparing reflux treatment methods including the TIF procedure, will be presented at the American College of Gastroenterology (ACG) 2015 Annual Scientific Meeting, October 16- 21, 2015 in Honolulu, Hawaii.
Eighty-seven patients were randomly assigned to the group that underwent the TIF procedure and then received an ongoing treatment of placebo medication. After more than 12 months, 72% reported elimination of troublesome regurgitation per Montreal consensus criteria.1
The study also found that the mean DeMeester Score decreased from 33.6 to 23.9 at 6 months and to 24.7 at > 12 months post-TIF (p < 0.05).
Eight participating U.S. academic and community centers screened 696 patients of which 129 were enrolled into the RESPECT study: TIF/placebo n=87; SHAM/PPI n=42.
“The 12-month data from the RESPECT study further supports the TIF procedure as an effective treatment option to eliminate troublesome regurgitation and improves the quality of life for select chronic GERD patients,” said Peter Kahrilas, MD, Professor of Medicine-Gastroenterology, Northwestern University and co-principal investigator.
Both groups of patients enrolled in the RESPECT study, and their caregivers, were blinded to therapy during follow-up which occurred at two, 12 and 26 weeks. At the six-month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure; 76% of sham/placebo group elected to crossover and receive a TIF procedure after un-blinding.
The RESPECT 12 month follow-up data will be displayed as a poster on Tuesday, October 20, 2015, 9:30 AM – 3:30 PM local time.
“Based on the improvements seen in these patients, we believe the TIF procedure is filling a treatment gap for patients who do not respond to PPI medications and want a less invasive procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions.
About Economic Data Study
Also being presented are results of a two-year study demonstrating the improved cost and healthcare utilization benefits of the TIF procedure in comparison to PPI medication and Nissen fundoplication.
In this study, the Optum healthcare database was utilized to determine overall resource utilization, which includes costs for hospitalizations, outpatient visits and PPI therapy. Of the 13,293 total patients included in the analysis, 10,486 patients were on high-dose PPI therapy, 2,734 underwent Nissen fundoplication, and 73 patients had the TIF procedure. At two years post-TIF procedure, median costs were comparable to those post-Nissen (TIF – $7,397, Nissen – $8,412) and healthcare utilization and total healthcare costs decreased compared to those associated with PPIs (TIF – $7,397, PPIs – $9,697).
“The TIF procedure is showing potential not only as a desirable GERD treatment, but as a cost-effective solution for patients,” said Lauren Gerson, MD, MSc, gastroenterologist at California Pacific Medical Center in San Francisco, CA. Dr. Gerson is the lead author of the study; this poster will also be on display Tuesday, October 20, 2015, 9:30 AM – 3:30 PM local time.