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Original Contribution
May 18, 2011

Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD: The LOTUS Randomized Clinical Trial

Author Affiliations

Author Affiliations: Department of Gastroenterology and Hepatology, Nantes University, and Centre d’Investigation Clinique INSERM, Nantes, France (Dr Galmiche); Institute of Medicine, Haukeland University Hospital, University of Bergen, Bergen, Norway (Dr Hatlebakk); Department of Surgery, North Tyneside General Hospital, North Shields, Tyne and Wear, England (Dr Attwood); Department of Gastroenterology, Dr Horst Schmidt Hospital, Wiesbaden, Germany (Dr Ell); Department of Surgical and Morphological Sciences, Anatomic Pathology Division, University of Genova, Genova, Italy (Dr Fiocca); AstraZeneca Research and Development, Mölndal, Sweden (Drs Eklund, Långström, and Lind); and Department of Surgery, Karolinska University Hospital, Huddinge, Sweden (Dr Lundell).

JAMA. 2011;305(19):1969-1977. doi:10.1001/jama.2011.626

Context Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery.

Objective To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD.

Design, Setting, and Participants The LOTUS trial, a 5-year exploratory randomized, open, parallel-group trial conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients with well-established chronic GERD who initially responded to acid suppression. A total of 372 patients (esomeprazole, n = 192; LARS, n = 180) completed 5-year follow-up.

Interventions Two hundred sixty-six patients were randomly assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actually underwent the operation.

Main Outcome Measure Time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates and analyzed using the Kaplan-Meier method.

Results Estimated remission rates at 5 years were 92% (95% confidence interval [CI], 89%-96%) in the esomeprazole group and 85% (95% CI, 81%-90%) in the LARS group (log-rank P = .048). The difference between groups was no longer statistically significant following best-case scenario modeling of the effects of study dropout. The prevalence and severity of symptoms at 5 years in the esomeprazole and LARS groups, respectively, were 16% and 8% for heartburn (P = .14), 13% and 2% for acid regurgitation (P < .001), 5% and 11% for dysphagia (P < .001), 28% and 40% for bloating (P < .001), and 40% and 57% for flatulence (P < .001). Mortality during the study was low (4 deaths in the esomeprazole group and 1 death in the LARS group) and not attributed to treatment, and the percentages of patients reporting serious adverse events were similar in the esomeprazole group (24.1%) and in the LARS group (28.6%).

Conclusion This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years.

Trial Registration clinicaltrials.gov Identifier: NCT00251927