Jan G Hatlebakk1, Frank Zerbib2, Stanislas Bruley des Varannes3, Stephen E Attwood4, Christian Ell5, Roberto Fiocca6, Jean-Paul Galmiche3, Stefan Eklund7, Göran Långström7, Tore Lind7, Lars R Lundell8. 1. Department of Medicine, Haukeland University Hospital, Bergen, Norway. Electronic address: jhat@helse-bergen.no. 2. Gastroenterology and Hepatology Department, Saint André Hospital, Centre Hospitalier Universitaire de Bordeaux, Université de Bordeaux, Bordeaux, France. 3. Institut des Maladies de I'Appareil Digestif, Université de Nantes, Nantes, France. 4. Department of Surgery, Durham University, Durham, United Kingdom. 5. Department of Gastroenterology, Dr Horst Schmidt Clinic, Wiesbaden, Germany. 6. Department of Surgical and Morphological Sciences, Anatomic Pathology Division, University of Genoa and IRCCS San Martino/IST, Genoa, Italy. 7. AstraZeneca Research and Development, Mölndal, Sweden. 8. Department of Surgery, Center for Digestive Diseases, Karolinska University Hospital, Huddinge, Sweden; CLINTEC, Karolinska Institutet, Stockholm, Sweden.
Abstract
BACKGROUND & AIMS: 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 oresomeprazole. 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 intragastricpH 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).
RCT Entities:
BACKGROUND & AIMS: 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: Andrew J Gawron; Reginald Bell; Barham K Abu Dayyeh; F P Buckley; Kenneth Chang; Christy M Dunst; Steven A Edmundowicz; Blair Jobe; John C Lipham; Dan Lister; Marcia Irene Canto; Michael S Smith; Anthony A Starpoli; George Triadafilopoulos; Thomas J Watson; Erik Wilson; John E Pandolfino; Alexander Kaizer; Zoe Van De Voorde; Rena Yadlapati Journal: Gastrointest Endosc Date: 2020-01-31 Impact factor: 9.427