UNMET NEEDS IN GERD TREATMENT
A standing room only crowd attended the presentation entitled, “Unmet Needs in GERD Treatment – Why you should consider Stretta in your clinical practice,” on May 8th in the ASGE Learning Center. Noted GERD experts were: Ronnie Fass, MD, Professor of Medicine, Case Western Reserve University, Director, Division of Gastroenterology and Hepatology and Head, Esophageal and Swallowing Center at MetroHealth Medical Center in Cleveland, Ohio; and Jan Tack, MD, PhD, Professor of Medicine, Head, Dept. of Clinical and Experimental Medicine and Head of Clinic, Dept. of Gastroenterology, Translational Research Center for Gastrointestinal Disorders (TARGID) at University Hospital KU, Leuven, Belgium.
Dr. Fass presented data on treatment outcome measures for GERD that challenge the assumption that symptom improvement and healing of erosive esophagitis correlate with normalization of esophageal acid exposure. Fass explained, “Multiple studies show discrepancies. Many patients report resolution of symptoms but have abnormal acid exposure. We know that 'normalized' acid defined by a measure of pH<4 is based on a symptom threshold which may be different for each patient.” Dr. Fass suggested a paradigm shift in how GERD outcomes are measured in therapeutic trials, “Symptom resolution should be the main clinical outcome, normalization of acid exposure or complete healing of erosive esophagitis are not necessary for symptom resolution.”
Fass went on to present data from his recently published Stretta Meta-Analysis. This landmark study included 28 studies, 2,468 subjects and up to 10-years of follow-up. The analysis showed that Stretta significantly reduced GERD symptoms while impacting physiological parameters, including acid exposure reduction and erosive esophagitis healing, with a majority of patients completely off PPIs and a very low complication rate.
Professor Tack then shared his own data from three studies that evaluated clinical outcomes and the mechanism of Stretta. Tack noted, “Our cohort series showed a robust and persistent effect of Stretta for 5-years on GERD symptoms, acid reduction and PPI use. In addition, mechanistic studies, including a randomized controlled trial, validated that Stretta changes tissue compliance without fibrosis, and that symptom improvement is not driven by a change in esophageal sensitivity. Rather, a reduction in acid exposure is driving the improvement in symptoms. Stretta increases muscle tone, and decreases compliance of the LES and GE junction. This allows less reflux volume, less acid in the esophagus, and improved symptoms of GERD. Stretta is easy to do, safe and effective.”
NEW STRETTA DATA
Data from three studies by Dr. Mark Noar, Director of The Heartburn and Reflux Center in Towson, Md., was also presented. These posters examined the benefits of Stretta at 10-year follow-up in difficult to treat GERD patients. The conclusions were:
– Barretts Esophagus tissue regressed in 76% of patients after treating GERD with Stretta (Tu1223).
– Stretta is effective at resolving GERD long-term regardless of BMI (Tu1228).
– Typical GERD and extra-esophageal GERD (LPR) had similar symptom control after Stretta (Tu1232).
Bob Knarr, CEO of Mederi noted a common thread in this data. “There is significant consistency in these clinical outcomes, Stretta has a unique mechanism that improves GERD symptoms, reduces acid exposure, with long-term effectiveness and a low complication rate.”
Click here to view a video of the Stretta presentation.