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Management of gastroesophageal reflux disease and erosive esophagitis in pediatric patients: Focus on delayed-release esomeprazole
Elizabet V Guimar es, Paula VP Guerra, Francisco J Penna
Therapeutics and Clinical Risk Management , 2010, DOI: http://dx.doi.org/10.2147/TCRM.S14425
Abstract: nagement of gastroesophageal reflux disease and erosive esophagitis in pediatric patients: Focus on delayed-release esomeprazole Review (5825) Total Article Views Authors: Elizabet V Guimar es, Paula VP Guerra, Francisco J Penna Published Date October 2010 Volume 2010:6 Pages 531 - 537 DOI: http://dx.doi.org/10.2147/TCRM.S14425 Elizabet V Guimar es, Paula VP Guerra, Francisco J Penna Department of Pediatrics, Medical School, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil Objective: To review the literature on the treatment of gastroesophageal reflux disease (GERD) with emphasis on proton pump inhibitors (PPIs), particularly on delayed-release esomeprazole, and to identify properties and adverse effects of PPIs observed in the treatment of GERD in children and adolescents. Sources: Electronic search of PubMed/Medline and Cochrane Collaboration databases, and of abstracts on DDW, NASPGHAN, and ESPGHAN. We focused on controlled and randomized studies published since 2000 and identified reviews that presented a consensual position, and directives published within the last 10 years. Main results: PPIs are considered better antisecretory agents than H2-receptor antagonists. Although all PPIs are similar, they are not identical in their pharmacologic properties. For example, the acid-suppressive effect of esomeprazole, the S-isomer of omeprazole, persists for more than 16 hours after administration of the morning dose. Therefore, it can control acidity after night meals better than a single dose of omeprazole. Moreover, the onset of the suppressive effect of esomeprazole is faster. It achieves acid inhibition faster than other PPIs. Conclusion: Currently, the mainstream treatment for GERD in children is a PPI. Although PPIs are safe drugs, effective in healing erosive esophagitis, and in relieving symptoms, studies with esomeprazole have shown that this drug has as powerful an ability to inhibit acid secretion as omeprazole. It also seems that some pharmacologic properties of esomeprazole are actually better for the treatment of GERD.
Management of gastroesophageal reflux disease and erosive esophagitis in pediatric patients: Focus on delayed-release esomeprazole
Elizabet V Guimarães,Paula VP Guerra,Francisco J Penna
Therapeutics and Clinical Risk Management , 2010,
Abstract: Elizabet V Guimar es, Paula VP Guerra, Francisco J PennaDepartment of Pediatrics, Medical School, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilObjective: To review the literature on the treatment of gastroesophageal reflux disease (GERD) with emphasis on proton pump inhibitors (PPIs), particularly on delayed-release esomeprazole, and to identify properties and adverse effects of PPIs observed in the treatment of GERD in children and adolescents.Sources: Electronic search of PubMed/Medline and Cochrane Collaboration databases, and of abstracts on DDW, NASPGHAN, and ESPGHAN. We focused on controlled and randomized studies published since 2000 and identified reviews that presented a consensual position, and directives published within the last 10 years.Main results: PPIs are considered better antisecretory agents than H2-receptor antagonists. Although all PPIs are similar, they are not identical in their pharmacologic properties. For example, the acid-suppressive effect of esomeprazole, the S-isomer of omeprazole, persists for more than 16 hours after administration of the morning dose. Therefore, it can control acidity after night meals better than a single dose of omeprazole. Moreover, the onset of the suppressive effect of esomeprazole is faster. It achieves acid inhibition faster than other PPIs.Conclusion: Currently, the mainstream treatment for GERD in children is a PPI. Although PPIs are safe drugs, effective in healing erosive esophagitis, and in relieving symptoms, studies with esomeprazole have shown that this drug has as powerful an ability to inhibit acid secretion as omeprazole. It also seems that some pharmacologic properties of esomeprazole are actually better for the treatment of GERD.Keywords: gastroesophageal reflux, therapy, child, adolescent.
Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study
Thirumazhisai Gunasekaran, Vasundhara Tolia, Richard B Colletti, Benjamin D Gold, Barry Traxler, Marta Illueca, Joseph A Crawley
BMC Gastroenterology , 2009, DOI: 10.1186/1471-230x-9-84
Abstract: This international, 31-site, 8-week safety study randomized adolescents, aged 12 to 17 years inclusive, with GERD to receive esomeprazole 20 or 40 mg once daily. The Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), previously validated in adults, consists of 25 questions grouped into 5 domains: emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. The QOLRAD was administered at the baseline and week-8 (final) visits.Of the 149 patients randomized, 134 completed the QOLRAD at baseline and final visits and were eligible for analysis of their HRQOL data. Baseline QOLRAD scores indicated GERD had a negative effect on the HRQOL of these adolescents, especially in the domains of vitality and emotional distress, and problems with food/drink. At the final visit, mean scores for all 5 QOLRAD domains improved significantly (P < .0001); change of scores (ie, delta) for all domains met or exceeded the adult QOLRAD minimal clinically significant difference standard of 0.5 units.GERD had a negative effect on QOL in adolescents. After esomeprazole treatment, statistically and clinically significant improvements occurred in all domains of the QOLRAD for these adolescents.D9614C00098; ClinicalTrials.gov Identifier NCT00241501Gastroesophageal reflux disease (GERD) is recognized increasingly as a common condition in adolescents [1]. Recent surveys of high school students show that at least 21% had significant GERD symptoms occurring a minimum of 1 time per month [2-4]. A survey conducted in pediatric practices revealed that 5.2%, 5.0%, and 8.2% of children and adolescents aged 10 to 17 years reported experiencing heartburn, epigastric pain, and regurgitation, respectively, in the previous week [5]. Moreover, in the same time period, 27.9% of children aged 10 to 17 years experienced abdominal pain, which may be a symptom of GERD [5].Findings of numerous studies have shown the negative effect of GERD on health-related quali
Clinical and endoscopic evaluantion of gastroesophageal reflux disease in patients successfully treated with esomeprazole
Silva, Edson Pedro da;Nader, Farid;Quilici, Flavio A.;Eisig, Jaime Natan;Zaterka, Schlioma;Meneghelli, Ulysses;
Arquivos de Gastroenterologia , 2003, DOI: 10.1590/S0004-28032003000400012
Abstract: background: esomeprazole, an s-isomer of omeprazole, is the first proton pump inhibitor developed as an optical isomer, and it has shown high healing rates in erosive esophagitis. aim: to evaluate the efficacy and tolerability of esomeprazole in subjects with erosive esophagitis, according to the los angeles classification study design: an open, multi-center clinical study. material and methods: two hundred and eighteen subjects with reflux esophagitis confirmed by endoscopy were included in an open, multi-center study in brazil. all of them received esomeprazole 40 mg, once daily, for a 4-week period. subjects who had unhealed esophagitis by week 4 continued the treatment for another 4 weeks. the primary efficacy endpoint was the healing rates by weeks 4 and 8. the secondary endpoints were the number of patients with symptom resolution by week 4, the number of days to sustained symptom resolution, number of symptom-free days and nights and safety and tolerability of the drug. results: healing rates by weeks 4 and 8 were 82% (confidence interval: 77.4%-87.6%) and 96.1% (confidence interval: 93.5% - 98.8%), respectively. ninety-nine (99%) of the patients had heartburn resolution by week 2. the most common adverse events were headache (4%), diarrhea (2.6%) and epigastric pain (2.2%). conclusion: for the studied period, esomeprazole was shown to be a safe and well-tolerated drug, providing significant healing rates of mucosal breaks, regardless of la classification, in patients with erosive esophagitis. esomeprazole was also shown to be effective in quickly relieving symptoms.
Relationship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease
Roy C Orlando, Sherry Liu, Marta Illueca
Clinical and Experimental Gastroenterology , 2010, DOI: http://dx.doi.org/10.2147/CEG.S12333
Abstract: tionship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease Original Research (3393) Total Article Views Authors: Roy C Orlando, Sherry Liu, Marta Illueca Published Date September 2010 Volume 2010:3 Pages 117 - 125 DOI: http://dx.doi.org/10.2147/CEG.S12333 Roy C Orlando1, Sherry Liu2, Marta Illueca3 1Department of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA, 2Department of Statistics and Informatics, 3Department of Clinical Development, AstraZeneca LP, Wilmington, DE, USA 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.
Induced Sputum Substance P in Children with Difficult-to-Treat Bronchial Asthma and Gastroesophageal Reflux: Effect of Esomeprazole Therapy  [PDF]
Adel Salah Bediwy,Mohamed Gamal A. Elkholy,Mohammed Al-Biltagi,Hesham Galal Amer,Eman Farid
International Journal of Pediatrics , 2011, DOI: 10.1155/2011/967460
Abstract: Objectives. To assess the induced sputum substance P (ISSP) levels in children having difficult-to-treat asthma (DA) with and without gastroesophageal reflux (GER). We aimed also to evaluate the association of GER with childhood DA, relationship of GER severity with childhood asthma control test (C-ACT), FEV1, peak expiratory flow (PEF) variability, and ISSP. Finally, we tried to evaluate esomeprazole treatment effect on C-ACT and FEV1 in children with DA. Methods. Spirometry, C-ACT, upper gastrointestinal endoscopy, and ISSP measurement were done for children with DA compared to healthy controls. Results. ISSP was high in DA with higher levels in the group having associated GER. In the latter group, ISSP and C-ACT improved significantly after esomeprazole treatment while FEV1 and PEF variability did not improve. Reflux severity was positively correlated with ISSP and negatively correlated with FEV1. Conclusions. GER was found in 49% of our patients with childhood DA. Very high ISSP levels in children with DA may be used as a marker for presence of GERD. Esomeprazole therapy improved asthma symptoms but did not improve lung function.
Relationship between esomeprazole dose and timing to heartburn resolution in selected patients with gastroesophageal reflux disease  [cached]
Roy C Orlando,Sherry Liu,Marta Illueca
Clinical and Experimental Gastroenterology , 2010,
Abstract: Roy C Orlando1, Sherry Liu2, Marta Illueca31Department of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA, 2Department of Statistics and Informatics, 3Department of Clinical Development, AstraZeneca LP, Wilmington, DE, USAObjective: 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.Keywords: acid suppressive therapy, GERD, proton pump inhibitor
Induced Sputum Substance P in Children with Difficult-to-Treat Bronchial Asthma and Gastroesophageal Reflux: Effect of Esomeprazole Therapy  [PDF]
Adel Salah Bediwy,Mohamed Gamal A. Elkholy,Mohammed Al-Biltagi,Hesham Galal Amer,Eman Farid
International Journal of Pediatrics , 2011, DOI: 10.1155/2011/967460
Abstract: Objectives. To assess the induced sputum substance P (ISSP) levels in children having difficult-to-treat asthma (DA) with and without gastroesophageal reflux (GER). We aimed also to evaluate the association of GER with childhood DA, relationship of GER severity with childhood asthma control test (C-ACT), FEV1, peak expiratory flow (PEF) variability, and ISSP. Finally, we tried to evaluate esomeprazole treatment effect on C-ACT and FEV1 in children with DA. Methods. Spirometry, C-ACT, upper gastrointestinal endoscopy, and ISSP measurement were done for children with DA compared to healthy controls. Results. ISSP was high in DA with higher levels in the group having associated GER. In the latter group, ISSP and C-ACT improved significantly after esomeprazole treatment while FEV1 and PEF variability did not improve. Reflux severity was positively correlated with ISSP and negatively correlated with FEV1. Conclusions. GER was found in 49% of our patients with childhood DA. Very high ISSP levels in children with DA may be used as a marker for presence of GERD. Esomeprazole therapy improved asthma symptoms but did not improve lung function. 1. Introduction Asthma is a common chronic complex inflammatory airway disorder characterized by variable degrees of recurring symptoms of airflow obstruction and bronchial hyperresponsiveness [1]. Although the majority of asthma patients can obtain the targeted level of control, some patients will not achieve control even with the best therapy [2]. Patients who do not reach an acceptable level of control with the use of reliever medication plus two or more controllers can be considered to have difficult-to-treat asthma [3]. The association between asthma and gastrooesophageal reflux (GER) has been debated for decades when Sir William Osler first observed the association between worsening asthma and distended stomach in 1892 [4]. The prevalence of symptoms of GER among individuals with asthma is substantially higher than in normal population and similarly the prevalence of asthma in individuals with GER is also higher than in controls [5]. Gastroesophageal reflux (GER) may cause chronic respiratory disease by vagal response and tracheal aspiration of gastric contents [6]. Aspiration of gastric contents changes pulmonary resistance and causes reactive airway obstruction [7]. Gastrooesophageal reflux may contribute to airway inflammatory events, possibly by sensory nerve stimulation and the subsequent release of tachykinins into the airway [8]. The tachykinins as substance P (SP) and neurokinin A are the neuropeptides most
The influence of demographic factors and health-related quality of life on treatment satisfaction in patients with gastroesophageal reflux disease treated with esomeprazole
Alessio Degl' Innocenti, Gordon H Guyatt, Ingela Wiklund, Diane Heels-Ansdell, David Armstrong, Carlo A Fallone, Lisa Tanser, Sander van Zanten, Samer El-Dika, Naoki Chiba, Alan N Barkun, Peggy Austin, Holger J Schünemann
Health and Quality of Life Outcomes , 2005, DOI: 10.1186/1477-7525-3-4
Abstract: Adult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables.Among the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment.Ethnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.The inclusion of patients' opinions in the assessment of interventions has gained greater prominence over the last decades. Regulator agencies now call for the inclusion of patient-reported outcomes (PRO) in clinical trials evaluating pharmaceuticals interventions [1-4]. PRO of interest include health-related quality of life (HRQL), symptom assessment, and more recently, treatment satisfaction, in gastroesophageal reflux disease (GERD).Whereas HRQL measures the patient's physical, psychological, and social level of function, treatment satisfaction assesses the patient's attitude towards the treatment, or the extent to which the patient is satisfied or not with the results of the treatment. Thus, treatment satisfaction focuses on the interaction of expectations and preferences for treatments and is defined as the individual's rating of important attributes of the process and outcomes of the treatment experience [5]. Coyne and co-workers [6] have summarized a number of patient important domai
Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study
Vasundhara Tolia, Nader N Youssef, Mark A Gilger, Barry Traxler, Marta Illueca
BMC Pediatrics , 2010, DOI: 10.1186/1471-2431-10-41
Abstract: Children aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux disease were randomized to esomeprazole 5 or 10 mg daily (< 20 kg) or 10 or 20 mg daily (≥ 20 kg) for 8 weeks. Patients with erosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.Of 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis without erosive esophagitis. Of the 45 patients who had erosive esophagitis and underwent follow-up endoscopy, 89% experienced erosion resolution. Dilation of intercellular space was reported in 24% of patients with histologic examination.Esomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in this pediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an important histologic marker of erosive esophagitis in children.D9614C00097; ClinicalTrials.gov identifier NCT00228527.Gastroesophageal reflux disease (GERD) increasingly is recognized in young children. A recent retrospective population-based cohort study in Rochester, MN, found that the incidence of GERD in children aged < 5 years was 0.9/1,000 person-years [1]. Data on the prevalence and severity of erosive esophagitis (EE) in young children are limited. The prevalence of endoscopy- and biopsy-proven EE in one study was 29% in 209 patients with GERD aged 18 months to 10 years who had no neurologic abnormalities or congenital esophageal anomalies [2]. A retrospective review of the Pediatric Endoscopy Database System-Clinical Outcomes Research Initiative (PEDS-CORI) demonstrated that, of 7,188 children aged ≤ 18 years who underwent endoscopy, 12.4% had EE [3].Although endoscopy is a valuable tool in the diagnosis of pediatric GERD and EE that provides macroscopic evidence of erosions, histology is important because abnormalities may be present without visible lesions on endoscopy. The North American Society for Pediatric Gastroente
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