title: Gastroesophageal Acid Reflux Control 5 Years After Antireflux Surgery, Compared With Long-term Esomeprazole Therapy.
abstract: OBJECTIVE
  We compared the ability of laparoscopic antireflux surgery (LARS) and esomeprazole to control esophageal acid exposure, over a 5-year period, in patients with chronic gastroesophageal reflux disease (GERD). We also studied whether intraesophageal and intragastric pH parameters off and on therapy were associated with long-term outcomes.
  
  
  METHODS
  We analyzed data from a prospective, randomized, open-label trial comparing the efficacy and safety of LARS vs esomeprazole (20 or 40 mg/d) over 5 years in patients with chronic GERD. Ambulatory intraesophageal and intragastric 24-hour pH monitoring data were compared between groups before LARS or the start of esomeprazole treatment, and 6 months and 5 years afterward. A secondary aim was to evaluate the association between baseline and 6-month pH parameters and esomeprazole dose escalation, reappearance of GERD symptoms, and treatment failure over 5 years in patients receiving LARS or esomeprazole.
  
  
  RESULTS
  In the LARS group (n = 116), the median 24-hour esophageal acid exposure was 8.6% at baseline and 0.7% after 6 months and 5 years (P < .001 vs baseline). In the esomeprazole group (n = 151), the median 24-hour esophageal acid exposure was 8.8% at baseline, 2.1% after 6 months, and 1.9% after 5 years (P < .001, therapy vs baseline, and LARS vs esomeprazole). Gastric acidity was stable in both groups. Patients who required a dose increase to 40 mg/d had more severe supine reflux at baseline, and decreased esophageal acid exposure (P < .02) and gastric acidity after dose escalation. Esophageal and intragastric pH parameters, off and on therapy, did not predict long-term symptom breakthrough.
  
  
  CONCLUSIONS
  In a prospective study of patients with chronic GERD, esophageal acid reflux was reduced greatly by LARS or esomeprazole therapy. However, patients receiving LARS had significantly greater reductions in 24-hour esophageal acid exposure after 6 months and 5 years. Esophageal and gastric pH, off and on therapy, did not predict long-term outcomes of patients. Abnormal supine acid exposure predicted esomeprazole dose escalation. ClinicalTrials.Gov identifier: NCT00251927 (available: http://clinicaltrials.gov/ct2/show/NCT00251927).
authors.affiliation: Department of Medicine, Haukeland University Hospital, Bergen, Norway. Electronic address: jhat@helse-bergen.no.
authors.forename: Jan G
authors.initials: JG
authors.lastname: Hatlebakk
authors.affiliation: Gastroenterology and Hepatology Department, Saint André Hospital, Centre Hospitalier Universitaire de Bordeaux, Université de Bordeaux, Bordeaux, France.
authors.forename: Frank
authors.initials: F
authors.lastname: Zerbib
authors.affiliation: Institut des Maladies de I'Appareil Digestif, Université de Nantes, Nantes, France.
authors.forename: Stanislas
authors.initials: S
authors.lastname: Bruley des Varannes
authors.affiliation: Department of Surgery, Durham University, Durham, United Kingdom.
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Attwood
authors.affiliation: Department of Gastroenterology, Dr Horst Schmidt Clinic, Wiesbaden, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Ell
authors.affiliation: Department of Surgical and Morphological Sciences, Anatomic Pathology Division, University of Genoa and IRCCS San Martino/IST, Genoa, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Fiocca
authors.affiliation: Institut des Maladies de I'Appareil Digestif, Université de Nantes, Nantes, France.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Galmiche
authors.affiliation: AstraZeneca Research and Development, Mölndal, Sweden.
authors.forename: Stefan
authors.initials: S
authors.lastname: Eklund
authors.affiliation: AstraZeneca Research and Development, Mölndal, Sweden.
authors.forename: Göran
authors.initials: G
authors.lastname: Långström
authors.affiliation: AstraZeneca Research and Development, Mölndal, Sweden.
authors.forename: Tore
authors.initials: T
authors.lastname: Lind
authors.affiliation: Department of Surgery, Center for Digestive Diseases, Karolinska University Hospital, Huddinge, Sweden; CLINTEC, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Lars R
authors.initials: LR
authors.lastname: Lundell
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D064098:Esomeprazole / Q000627:therapeutic use*; D050782:Esophageal pH Monitoring; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors; D064098:Esomeprazole
keywords: Clinical Trial; Esophageal pH Monitoring; LOTUS Study; Proton Pump Inhibitor