Dataset Information

Relationship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease.

ABSTRACT: OBJECTIVE:To increase response rates to therapy by increasing the dosage of proton pump inhibitor (PPI) therapy in patients with gastroesophageal reflux disease (GERD) whose symptoms are predominantly associated with acid reflux. METHODS:In this double-blind, randomized, proof-of-concept study, 369 patients with GERD and moderate heartburn lasting ?three days/week, a history of response to antacids/acid suppression therapy, and a positive esophageal acid perfusion test result were randomized to esomeprazole 20 or 40 mg once daily, or to 40 mg twice daily for four weeks. Heartburn symptom relief/resolution was subsequently evaluated. RESULTS:In this study population, no relationship was apparent between esomeprazole dosage and efficacy variables for sustained heartburn resolution (seven days without symptoms) at week 4 (48.0%, 44.0%, and 41.4% for esomeprazole 20 mg once daily, 40 mg once daily, and 40 mg twice daily, respectively). Nocturnal heartburn resolution with esomeprazole 40 mg twice daily showed a numeric improvement trend versus esomeprazole 20 and 40 mg once daily, but this was not statistically significant. CONCLUSIONS:Heartburn resolution rates at four weeks were similar for all esomeprazole dosages and comparable with rates reported previously, suggesting a plateau effect in terms of clinical response to acid suppression with PPI therapy in this population of selected GERD patients.

SUBMITTER: Orlando RC

PROVIDER: S-EPMC3108657 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Relationship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease.

Orlando Roy C RC Liu Sherry S Illueca Marta M

Clinical and experimental gastroenterology 20100906

<h4>Objective</h4>To increase response rates to therapy by increasing the dosage of proton pump inhibitor (PPI) therapy in patients with gastroesophageal reflux disease (GERD) whose symptoms are predominantly associated with acid reflux.<h4>Methods</h4>In this double-blind, randomized, proof-of-concept study, 369 patients with GERD and moderate heartburn lasting ≥three days/week, a history of response to antacids/acid suppression therapy, and a positive esophageal acid perfusion test result were ...[more]

PMID: 21694855

Similar Datasets

Project description:Most patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication. The aim of this study was to compare willingness to continue treatment with esomeprazole on-demand versus continuous maintenance therapy for symptom control in patients with non-erosive reflux disease (NERD) after 6 months.This multicenter, open-label, randomized, parallel-group study enrolled adults with NERD who were heartburn-free after 4 weeks' treatment with esomeprazole 20 mg daily. Patients received esomeprazole 20 mg daily continuously or on-demand for 6 months. The primary variable was discontinuation due to unsatisfactory treatment. On-demand treatment was considered non-inferior if the upper limit of the one-sided 95 % confidence interval (CI) for the difference between treatments was <10 %.Of 877 patients enrolled, 598 were randomized to maintenance treatment (continuous: n = 297; on-demand: n = 301). Discontinuation due to unsatisfactory treatment was 6.3 % for on-demand and 9.8 % for continuous treatment (difference -3.5 % [90 % CI: -7.1 %, 0.2 %]). In total, 82.1 and 86.2 % of patients taking on-demand and continuous therapy, respectively, were satisfied with the treatment of heartburn and regurgitation symptoms, a secondary variable (P = NS). Mean study drug consumption was 0.41 and 0.91 tablets/day, respectively. Overall, 5 % of the on-demand group developed reflux esophagitis versus none in the continuous group (P < 0.0001). The Gastrointestinal Symptom Rating Scale Reflux dimension was also improved for continuous versus on-demand treatment. Esomeprazole was well tolerated.In terms of willingness to continue treatment, on-demand treatment with esomeprazole 20 mg was non-inferior to continuous maintenance treatment and reduced medication usage in patients with NERD who had achieved symptom control with initial esomeprazole treatment.ClinicalTrials.gov identifier (NCT number): NCT02670642 ; Date of registration: December 2015.

Project description:ImportanceCohort studies, mainly based on questionnaires and interviews, have reported high rates of reflux recurrence after antireflux surgery, which may have contributed to a decline in its use. Reflux recurrence after laparoscopic antireflux surgery has not been assessed in a long-term population-based study of unselected patients.ObjectivesTo determine the risk of reflux recurrence after laparoscopic antireflux surgery and to identify risk factors for recurrence.Design and settingNationwide population-based retrospective cohort study in Sweden between January 1, 2005, and December 31, 2014, based on all Swedish health care and including 2655 patients who underwent laparoscopic antireflux surgery according to the Swedish Patient Registry. Their records were linked to the Swedish Causes of Death Registry and Prescribed Drug Registry.ExposuresPrimary laparoscopic antireflux surgery due to gastroesophageal reflux disease in adults (>18 years).Main outcomes and measuresThe outcome was recurrence of reflux, defined as use of antireflux medication (proton pump inhibitors or histamine2 receptor antagonists for >6 months) or secondary antireflux surgery. Multivariable Cox regression was used to assess risk factors for reflux recurrence.ResultsAmong all 2655 patients who underwent antireflux surgery (median age, 51.0 years; interquartile range, 40.0-61.0 years; 1354 men [51.0%]) and were followed up for a median of 5.6 years, 470 patients (17.7%) had reflux recurrence; 393 (83.6%) received long-term antireflux medication and 77 (16.4%) underwent secondary antireflux surgery. Risk factors for reflux recurrence included female sex (hazard ratio [HR], 1.57 [95% CI, 1.29-1.90]; 286 of 1301 women [22.0%] and 184 of 1354 men [13.6%] had recurrence of reflux), older age (HR, 1.41 [95% CI, 1.10-1.81] for age ≥61 years compared with ≤45 years; recurrence among 156 of 715 patients and 133 of 989 patients, respectively), and comorbidity (HR, 1.36 [95% CI, 1.13-1.65] for Charlson comorbidity index score ≥1 compared with 0; recurrence among 180 of 804 patients and 290 of 1851 patients, respectively). Hospital volume of antireflux surgery was not associated with risk of reflux recurrence (HR, 1.09 [95% CI, 0.77-1.53] for hospital volume ≤24 surgeries compared with ≥76 surgeries; recurrence among 38 of 266 patients [14.3%] and 271 of 1526 patients [17.8%], respectively).Conclusions and relevanceAmong patients who underwent primary laparoscopic antireflux surgery, 17.7% experienced recurrent gastroesophageal reflux requiring long-term medication use or secondary antireflux surgery. Risk factors for recurrence were older age, female sex, and comorbidity. Laparoscopic antireflux surgery was associated with a relatively high rate of recurrent gastroesophageal reflux disease requiring treatment, diminishing some of the benefits of the operation.

Project description:ObjectivesThe role of Helicobacter pylori (H pylori) in gastroesophageal reflux disease (GERD) remains controversial, particularly in children, because there are limited published data. Adult studies suggested that H pylori infection may protect against GERD by causing atrophic gastritis, which leads to reduced gastric acid secretion. The objective of our study was to determine the role of H pylori infection in the development of GERD in a pediatric population.Patients and methodsA retrospective analysis of 420 patients (M:F = 214:206) who underwent esophagogastroduodenoscopy (EGD) with biopsies between January 2000 and April 2006 was conducted. Patient demographics, clinical indications for EGD and the prevalence of reflux esophagitis (RE), the biomarker for GERD, in 2 groups, H pylori positive and H pylori negative, were reviewed. The prevalence of RE in the H pylori-positive and H pylori-negative groups was further analyzed on the basis of sex and age (<1 year, 1-10 years, >10 years). The mean age of the study population was 8.2 years (range 0-20 years). The clinical indications for EGD were as follows: recurrent abdominal pain (n = 186, 44%), malabsorption (n = 80, 19%), persistent vomiting (n = 80, 19%), suspected eosinophilic gastrointestinal disorders (n = 63, 15%), and others such as upper gastrointestinal bleeding or inflammatory bowel disease surveillance (n = 11, 3%). Statistical analysis was performed by using chi test, Fisher exact test, and multivariate logistical regression analysis.ResultsAmong the 420 patients, 16 patients (3.8%) were positive for H pylori and 167 patients (39.8%) were found to have RE. Thirteen patients with H pylori were found to have histologic evidence of RE. The prevalence of RE in the H pylori-positive population was 81.3% compared with 38.1% in the H pylori-negative population (P < or = 0.05). There were no patients with H pylori in the youngest age group. In the second age group (1-10 years), 100% of the H pylori-positive patients had RE, whereas 44.6% of the H pylori-negative patients had RE (P < or = 0.05). Both male and female patients with H pylori had a higher prevalence of RE, 77.8% and 85.7%, respectively. On a multivariate logistical regression, for the overall study cohort, H pylori-positive patients had an odds ratio of 5.79 of developing RE compared with H pylori-negative patients (P < or = 0.05).ConclusionsOur study results indicate that there is a significantly higher prevalence of RE in an H pylori-infected cohort independent of age or sex. The findings suggest that H pylori infection in children is positively associated with RE.

Dataset Information

Relationship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease.

Publications

Relationship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets