BackgroundManagement of patients with gastro-oesophageal reflux disease (GORD) can be assisted by information predicting the likely response to proton pump inhibitor (PPI) treatment. The aim was to undertake a study of GORD patients designed to approximate ordinary clinical practice that would identify patient characteristics predicting symptomatic response to pantoprazole treatment.Methods1888 patients with symptoms of GORD were enrolled in a multicentre, multinational, prospective, open study of 8 weeks pantoprazole treatment, 40 mg daily. Response was assessed by using the ReQuest™ questionnaire, by the investigator making conventional clinical enquiry and by asking patients about their satisfaction with symptom control. Factors including pre-treatment oesophagitis, gender, age, body mass index (BMI), Helicobacter pylori status, anxiety and depression, and concurrent IBS symptoms were examined using logistic regression to determine if they were related to response, judged from the ReQuest™-GI score.ResultsPoorer treatment responses were associated with non-erosive reflux disease, female gender, lower BMI, anxiety and concurrent irritable bowel syndrome symptoms before treatment. No association was found with age, Helicobacter pylori status or oesophagitis grade. Some reflux-related symptoms were still present in 14% of patients who declared themselves 'well-satisfied' with their symptom control.ConclusionsSome readily identifiable features help to predict symptomatic responses to a PPI and consequently may help in managing patient expectation. ClinicalTrial.gov identifier: NCT00312806.

Background/AimsTo evaluate the effectiveness of pantoprazole magnesium (pantoprazole-Mg) 40 mg in the relief of esophageal and extra-esophageal symptoms of gastroesophageal reflux disease (GERD), particularly night-time symptoms.MethodsPatients (aged 18-50 years) with 3-month history of heartburn and/or acid regurgitation plus at least one other symptom in the last week were enrolled in a nationwide, prospective and observational study in Mexico. Patients received pantoprazole-Mg 40 mg once daily during 4 weeks. Symptoms were assessed through a physician-administered structured interview and the patient-completed ReQuest in Practice™ questionnaire. Night-time GERD was defined as arousal from sleep during the night due to GERD-associated symptoms.ResultsOut of 4,343 patients included at basal visit, 3,665 were considered for the effectiveness per protocol analysis. At baseline, patients had a median of 8 GERD related symptoms. Patients with night-time GERD symptoms (42.7%) were more likely to have extra-esophageal symptoms (P < 0.001) than other GERD patients. Pantoprazole-Mg 40 mg once daily for 4 weeks improved a broad range of GERD-associated symptoms from baseline (80% reduction on physicians assessments; 68-77% reduction on ReQuest in Practice™ dimensions), including both day- and night-time GERD symptoms; improvements were the greatest for extra-esophageal symptoms in patients with night-time symptoms. Pantoprazole-Mg was well tolerated.ConclusionsPantoprazole-Mg 40 mg significantly improved a broad range of esophageal and extra-esophageal GERD related symptoms including sleep disturbances, as well as well-being, in patients with daytime or night-time GERD, making it a good option for patients with GERD, especially when extra-esophageal and night-time symptoms are present.

BackgroundSymptoms suggestive of functional dyspepsia (FD) and irritable bowel syndrome (IBS) frequently overlap with those of gastroesophageal reflux disease. Despite the high prevalence of symptomatic overlap, the underlying etiology remains poorly defined. We assessed the correlation of symptomatic relief and health-related quality of life (HRQoL) with healing of reflux esophagitis to further derive insights into the underlying etiology.Methods626 patients with reflux esophagitis were enrolled into one of two treatment groups (classical healing concept or the complete remission concept) to investigate differences in treatment intensity. Patients were treated with pantoprazole until esophageal mucosal healing. Remission was followed for up to 6 months without treatment. Gastro-intestinal symptoms and HRQoL were analyzed using disease-specific, psychometrically validated patient-reported outcome instruments (ReQuest™, GERDyzer™).ResultsSymptomatic burden reflected by ReQuest™ substantially decreased from baseline to end of treatment by 83% and 88% in either treatment group, respectively. ReQuest™ scores significantly decreased in patients with or without heartburn and in those with symptoms suggestive of FD and IBS, indicating response of all symptom categories to treatment (p < 0.005). Therapy-associated relief of symptoms was paralleled by substantial gains in HRQoL, which continued to stabilize post-treatment.ConclusionsPantoprazole is effective in relieving upper and lower gastro-intestinal symptoms overlapping with erosive esophagitis, and provides sustained improvement in HRQoL post-treatment. Our results propose a link between both healing of erosive esophagitis and the slower remission of upper and lower gastro-intestinal symptoms. Since the improvement observed is likely to be multifactorial, the possibility for an immune-mediated etiology and identification of putative susceptibility factors by genome-wide association study may provide focus for future research.Trial registrationClinicalTrials.gov identifier: NCT00325676.