Stretta clinically effective, safe for GERD
Endoscopic radiofrequency treatment with the Stretta procedure is a clinically effective and safe alternative for managing GERD, according to the results of a systematic review and meta-analysis.
“The results of this study show that Stretta [Mederi Therapeutics] significantly reduces GERD symptoms while also impacting the physiological parameters, such as reducing acid exposure, and healing erosive esophagitis,” Ronnie Fass, MD, head of the Esophageal and Swallowing Center and director of gastroenterology and hepatology at Metro Health Medical Center, and a professor at Case Western University, said in a press release.
Fass and colleagues — including Frederick Cahn, PhD, a statistical expert and principal of Biomedical Strategies — conducted a literature search through May 2016, and included 28 studies (4 randomized controlled trials, 23 cohort studies and 1 registry study) comprising 2,468 patients treated with Stretta therapy in their meta-analysis. The data provided up to 10 years of follow-up (mean follow-up, 25.4 months).
Stretta led to significant improvements in health-related quality of life (P < .001) and heartburn (P < .001), and about half of patients could discontinue PPI use after Stretta therapy (51%; P < .001).
Further, Stretta reduced the incidence of erosive esophagitis by 24%, which reached significance in the fixed effects model (P < .001), and significantly reduced esophageal acid exposure (P < .001).
However, improvements in lower esophageal sphincter basal pressure were not significantly better than sham procedures.
The adverse event rates were 0.93% for Stretta vs. 7.18% for laparoscopic fundoplication. Small erosions and mucosal lacerations were the most common adverse events reported with Stretta (<1%).
“A thorough analysis of the studies, following Cochrane recommended methodology, demonstrated they are of a high quality with low risk of bias,” Cahn said in the press release. “We also noted a consistency of positive outcomes across the wide range of studies.”
Strengths of this meta-analysis include follow-up data spanning up to 10 years, and the large number of included studies and patients, “which places this meta-analysis in the top 1% of systematic reviews and meta-analyses,” Cahn added.
“This comprehensive analysis combined our clinical expertise with Dr. Cahn’s statistical experience to produce the most thorough and objective review of currently available data. The results demonstrate that Stretta is a clinically effective and safe therapy for GERD,” Fass said in the press release.
Further, a recent budget impact analysis published last year in Managed Care showed the use of Stretta therapy vs. long-term medications or surgery led to significant cost savings for payers, according to the press release.
“The combination of our new meta-analysis and the economic data further support the use of Stretta as a treatment for GERD patients,” Fass noted. – by Adam Leitenberger
Disclosures: Cahn reports he is a principal with BioMedical Strategies and a business advisor to Baker Tilly. Fass reports he is an advisor to Ironwood and Mederi Therapeutics, a speaker for AstraZeneca, Dr. Reddy, Mederi Therapeutics and Takeda, and has received research grants from Ironwood. Please see the full study for a list of all other researchers’ relevant financial disclosures.