title: Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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%).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00251927.
authors.affiliation: Department of Gastroenterology and Hepatology, Nantes University, CIC INSERM, Place Alexis Ricordeau, 44093 Nantes, France. jeanpaul.galmiche@chu-nantes.fr
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Galmiche
authors.forename: Jan
authors.initials: J
authors.lastname: Hatlebakk
authors.forename: Stephen
authors.initials: S
authors.lastname: Attwood
authors.forename: Christian
authors.initials: C
authors.lastname: Ell
authors.forename: Roberto
authors.initials: R
authors.lastname: Fiocca
authors.forename: Stefan
authors.initials: S
authors.lastname: Eklund
authors.forename: Göran
authors.initials: G
authors.lastname: Långström
authors.forename: Tore
authors.initials: T
authors.lastname: Lind
authors.forename: Lars
authors.initials: L
authors.lastname: Lundell
mesh_terms: D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D013505:Digestive System Surgical Procedures / Q000009:adverse effects / Q000379:methods; D064098:Esomeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D064098:Esomeprazole