May 23, 2014
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Stretta therapy provided long-term efficacy, safety in treating GERD patients

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Stretta radiofrequency therapy showed long-term efficacy, safety and durability in patients with gastroesophageal reflux disease who had poor results when using proton pump inhibitors in a recent study.

Stretta (Mederi Therapeutics) utilizes low power, low temperature radiofrequency energy to reduce gastroesophageal reflux disease (GERD) symptoms by remodeling the lower esophageal sphincter.

This single-center follow-up study assessed GERD outcomes in 26 patients who underwent Stretta therapy between June 2002 and March 2013 and were followed for at least 8 years. Follow-up results at 8 years were compared with baseline data and a previous 4-year follow-up, including clinical evaluation, upper endoscopy, esophageal pressure and pH-metric studies. Patient outcomes were assessed based on heartburn and heartburn-related quality of life (HRQL) scores, general quality of life (QoL) score determined by SF-36 survey, medication use, lower esophageal sphincter pressure and esophageal acidic exposure.

Significant decreases in heartburn (mean, –2.8 points; 95% CI, –1.8 to –3.6) and HRQL scores (mean, –14 points; 95% CI, –10 to –21) were observed at 4 years, and they persisted at 8 years (mean,–1.8 points; 95% CI, –1.4 to –2.2 for heartburn; mean, –11 points; 95% CI, –9 to –14 for HRQL). QoL scores significantly improved in all patients at 4 years (mean increase in mental SF-36, 13 points; 95% CI, 8-17; mean increase in physical SF-36, 12 points; 95% CI, 9-13) and at 8 years (mean mental increase, 13 points; 95% CI, 9-15; mean physical increase, 9 points; 95% CI, 6-11). Furthermore, at both follow-ups, 80.7% and 76.9% of patients had stopped proton pump inhibitor therapy, respectively (P=.0001 for both).

One of the study’s most significant findings is “the complete absence of any Barrett’s esophagus or erosive esophagitis,” Luca Dughera, MD, of City of Health and Sciences Hospital, Turin, Italy, said in a press release . “These findings make clear that along with excellent symptom control, Stretta reduces patient dependence on medication while also reducing harmful effects of prolonged esophageal acid exposure, a principal cause of Barrett’s and esophagitis.”

“This study adds to a growing body of long-term data … making Stretta by far the most studied nonsurgical treatment for GERD,” Will Rutan, CEO of Mederi Therapeutics, said in the release.

Disclosure: The researchers report no relevant financial disclosures.