TEMPO Study Level 1 Data Directly Comparing Transoral Incisionless Fundoplication (TIF) Procedure to PPI Use Presented at DDW® 2013
Redwood City, CA (May 21, 2013)–EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced new data from a prospective, randomized, controlled trial show that patients with GERD who underwent Transoral Incisionless Fundoplication (TIF®) procedures with the EsophyX® device experienced significantly better outcomes in reduction of troublesome GERD symptoms after six months than patients who continued to take maximum daily doses of proton pump inhibitor (PPI) medications for that time period.
In this study, Transoral Incisionless Fundoplication (TIF) was superior to maximal PPI dose in elimination of daily troublesome typical and atypical chronic GERD symptoms such as heartburn, regurgitation, globus sensation, hoarseness and cough at 6-month follow-up.
Daily bothersome heartburn was eliminated in 90% of patients in the TIF group versus only 13% in the PPI group. Furthermore, 90% of patients in the TIF group completely ceased PPI use. Both groups achieved similar normalization of distal esophageal acid exposure (54% of patients in the TIF group and 52% of patients in the PPI group). There was no difference between treatment groups in the clinical characterizations of the disease at baseline.
Karim S. Trad, MD, surgeon at George Washington University School of Medicine and Health Sciences, principal investigator of the TIF® versus Medical PPI Management of Refractory GERD symptoms (TEMPO) trial, presented the first six month data from the study during the American Gastroenterological Association’s Late-breaking abstract session at the 2013 DDW® Annual Meeting in Orlando, Florida.
“This randomized controlled study establishes for the first time that, for some patients, the TIF procedure is better than maximal dose PPI therapy in controlling a whole range of GERD symptoms,” said Dr. Trad. “Going forward, TIF should be offered as an alternative to the right patients who are not completely responsive to PPIs, or who are seeking to avoid the long-term side effects of medications”.
The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g. diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Patients implement these recommendations in an effort to manage their symptoms and, for many; quality of life becomes negatively impacted over time.
“The TIF procedure’s primary objective is to address failed anatomy in order to augment the body’s natural barrier and protect the esophagus from normal stomach chemistry,” said Mike Kleine, President and CEO of EGS. “Using drugs to artificially neutralize stomach acid for prolonged periods has to be problematic – stomach acid has an important role in normal GI function. A successful outcome for us is to normalize a patient’s life as much as possible.”
The TEMPO data include results from 63 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices. TEMPO was designed to assess the safety and efficacy of the TIF procedure as compared with high-dose PPI therapy to treat symptoms associated with chronic GERD. Patients will continue to be followed until they have completed 12-, 24-, and 36-month follow-up.