Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial.

Abstract

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.

• Authors: Jean-Paul Galmiche, Jan Hatlebakk, Stephen Attwood, Christian Ell, Roberto Fiocca, Stefan Eklund, Göran Långström, Tore Lind, Lars Lundell, LOTUS Trial Collaborators
• Journal: JAMA (JAMA) Vol. 305 Issue 19 Pg. 1969-77 (May 18 2011) ISSN: 1538-3598 [Electronic] United States
• PMID: 21586712 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Ulcer Agents
• Esomeprazole

Topics

• Adult
• Anti-Ulcer Agents (administration & dosage, adverse effects)
• Chronic Disease
• Digestive System Surgical Procedures (adverse effects, methods)
• Esomeprazole (administration & dosage, adverse effects)
• Female
• Gastroesophageal Reflux (drug therapy, surgery)
• Humans
• Laparoscopy (adverse effects, methods)
• Male
• Middle Aged
• Remission Induction
• Severity of Illness Index
• Treatment Outcome