Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD: The LOTUS Randomized Clinical Trial
Galmiche JP, Hatlebakk J, Attwood S, et al.
To test the efficacy of the PPI esomeprazole compared with laparoscopic antireflux surgery (LARS), European researchers conducted an industry-sponsored, multicenter study in which 554 patients with established gastroesophageal reflux disease (GERD) and verified responsiveness to PPIs were randomly assigned to receive either esomeprazole (20 mg daily, increased to 40 mg daily if needed) or LARS. The primary outcome was symptom control excluding the need to escalate treatment beyond the study protocol. Secondary outcomes were residual GERD symptoms, including acid regurgitation, dysphagia, heartburn, bloating, diarrhea, and flatulence.
At 5 years, the remission rate was borderline significantly higher in the esomeprazole group than the LARS group (92% vs. 85%; P = .048). Safety outcomes in both groups were excellent, with no perioperative deaths, a low rate of perioperative morbidity (3%), and no serious adverse events attributed to esomeprazole therapy alone. Acid regurgitation was more common in the esomeprazole group than the LARS group (13% vs 2%; P <.001), but dysphagia was less common (5% vs 11%; P <.001), as were bloating (28% vs 40%; P < .001) and flatulence (40% vs 57%; P < .001).
Why Is This a Game Changer?
The excellent surgical results in this study are likely a reflection of the pre-selection bias for expert surgeons. Accordingly, these outcomes should not be considered as representative of all antireflux surgeries. Although this trial was not designed as a superiority or equivalence study for esomeprazole therapy vs LARS, given the impressive data for the primary outcome of symptom control, the differences in secondary symptom outcomes, and the risks for surgical intervention, long-term medical therapy seems to be a resounding best choice for patients who are willing to remain on daily GERD medication.
Medscape Gastroenterology © 2011
Cite this: David A. Johnson. Game Changers in Gastroenterology: 2011 - Medscape - Nov 23, 2011.