Tu1127 Health-Related Quality of Life in a Cohort of Children With Chronic Hepatitis B

38.6%, 43.6%, 11.4%, 7.1%, p=0.007), when compared with the placebo group. Conclusions: Improvement of esophageal acid clearance appears to be an important factor in the treatment of reflux disease. Acotiamide therefore may improve esophageal acid clearance in subjects with peristaltic abnormality by improving the patterns of primary peristalsis. Tu1127 Health-Related Quality of Life in a Cohort of Children With Chronic Hepatitis B Sarah J. Schwarzenberg, Yona K. Cloonan, Kathleen B. Schwarz, Karen F. Murray, Simon Ling, Noberto Rodriguez-baez, Philip Rosenthal, Jeffrey Teckman Background Health-related quality of life (HRQOL) is impaired in adults with HBV; we assessed HRQOL in children enrolled in the multicenter HBRN Pediatric Cohort Study. Methods The Child Health Questionnaire (CHQ), a validated generic pediatric HRQOL instrument measuring health in physical, psychological and social domains, was completed for HBsAg+ children ≥5y. CHQ-PF50 was completed by parents/caregivers with children 5-10y; children >10y completed CHQ-CF87. Categorical demographic and disease-related characteristics were described using frequency and percent. For each CHQ scale, median scaled score and interquartile range (25th-75th percentiles) were calculated. Results are presented separately by 1) sex, 2) HBV phenotype, and 3) whether children were living with biologic or adoptive parents. Results 197 of 224 children enrolled had CHQ collected; 36% were <10y, 33% were male, and 59% were adopted. Of 193 with phenotype data, 41% were immune tolerant, 22% immune active, 12% inactive carrier, 24% indeterminate. CHQ scales with the lowest median scores were: General Health Perceptions (PF50 70.8, CF87 66.0), Behavior (PF50 80.8, CF87 78.8), and Mental Health (PF50 80.0, CF87 80.5). The median score for PF50 Emotional Impact on Parent was 83.3. All other scales had a median score of at least 85.0. When evaluated separately by sex, phenotype and adoption status, similar patterns were observed across groups, with the four scales listed above having the lowest median scores. For gender, median score differential >15 points was seen for PF50 Emotional Impact on Parent (male 58.3, female 83.3) and PF50 Family Activities (male 81.3, female 100.0). Median psychosocial summary T-scores were lower in males (47.4) than females (54.7), with a differential of <1 for the physical summary. For phenotype, median score differential >20 points was seen for PF50 Emotional Impact on Parent (45.8 immune active, 83.3 immune tolerant) and CF87 Family Activity (70.8 indeterminate, 91.7 immune tolerant). Median psychosocial summary T-scores ranged from 46.1 (immune active) to 58.2 (inactive carrier), with a differential of <2 across phenotypes for the physical summary. For adoption status, median scores did not differ on any CHQ scales. Median T-score differential of <3 were observed for both the psychosocial and physical summary measures. Conclusions In a large cohort of HBsAg+ children, parents of young boys experience a greater impact on parental emotional health and family activity than parents of young girls. Greater viral activity impacts parent and family CHQ across all age groups. Children living with adoptive and biologic parents do not differ with respect to HRQOL. Tu1128 Outcomes in Pediatric Eosinophilic Esophagitis Treated With Cow's Milk Elimination Versus Fluticasone Patrice Kruszewski, John M. Russo, Elizabeth A. Erwin Eosinophilic esophagitis (EoE) is a chronic immune-mediated inflammatory condition of the esophagus that is associated with food allergens. EoE is defined by ≥15 esophageal eosinophils per high power field (eos/hpf) and clinical symptoms that include failure to thrive, dysphagia, vomiting and abdominal pain. Older patients can present with food impactions. Current therapy for EoE includes proton pump inhibitor (PPI) combined with topical corticosteroids and/or complicated dietary changes. Because a significant proportion of patients improve with elimination of cow's milk alone, our objective was to compare outcomes after elimination of this single food with current standard medical therapy. Esophageal histology and clinical symptom changes were compared in children newly diagnosed with EoE and treated with PPI and fluticasone (n= 17) or PPI and elimination of cow's milk (n=7) for 8 weeks. Quality of life (QOL) and symptoms were assessed using the validated PedsQL™ EoE. Complete histological response was defined as <5 eos/hpf on follow-up biopsy. Partial response was defined as having 5-14 eos/hpf on biopsy. Twenty nine children were enrolled in the study (age range 2-17 y; 65% male), 19 children chose the fluticasone therapy and 10 children chose to eliminate cow's milk from their diet. Five patients did not complete the study. Mean esophageal eosinophil count was 66/hpf for those receiving fluticasone therapy and 48/hpf for those subjects eliminating cow's milk (p=0.1). Initial mean EoE symptom module scores were 63 for the subjects in the fluticasone group and 59 for the subjects in the dietary group (p=0.4). There were no significant differences in baseline characteristics between the two groups. The mean decrease in esophageal eosinophil count in patients treated with fluticasone was 56/hpf compared with 30/hpf in patients treated with cow's milk elimination (p=0.2). Eleven subjects treated with fluticasone were classified as complete responders compared with one subject treated with diet (p=0.08). Additionally, in the fluticasone group there was one partial responder compared with three partial responders in the cow's milk elimination group. Mean EoE symptom module scores improved by 13 points in subjects treated with fluticasone as compared with 23 in subjects treated with diet (p=0.3). The dietary treatment group exhibited greater improvement in 4 of the 5 module scores: Symptoms II (i.e. dysphagia and feeding difficulty), treatment, worry and communication. In summary, cow's milk elimination showed a trend for greater improvement in QOL and symptoms compared with fluticasone therapy. Histologic responses were not significantly better with fluticasone treatment. Thus, a simpler dietary regimen of cow's milk elimination may be effective and better received for a subset of pediatric EoE patients who wish to avoid long-term medications.

a

Administered as 22.3 mg esomeprazole magnesium trihydrate. bData for day 2 are cumulative rates for days 1 and 2. ESO, esomeprazole; GERD, gastroesophageal reflux disease; HB, heartburn.

Tu1126 Effects of Acotiamide on Esophageal Motility in Healthy Volunteers: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study Katsuhiko Iwakiri, Shintaro Hoshino, Norio Itokawa, Masanori Atsukawa, Nana Takenouchi, Noriyuki Kawami, Choitsu Sakamoto Background: Acotiamide is a new drug which exerts prokinetic activity by enhancing acetylcholine release and it has also been reported that acotiamide enhances gastric emptying. The effects of acotiamide on esophageal motility, however are not known. The aim of this study was to investigate the effects of acotiamide on esophageal motility in healthy volunteers. Methods: In 30 healthy volunteers, 100 mg of acotiamide or a placebo three times a day for 7 days were administered in a randomized, double-blind, placebo-controlled, crossover design, separated by a 28-day wash-out period. On the seventh day of treatment, basal LES pressure and primary peristalsis, in response to a 5-ml water bolus, were assessed using high-resolution manometry. Results: Basal LES pressure (28.2 mmHg (21.4-30.9), median (interquartile range)) in the acotiamide group was significantly (p=0.0011) higher than that of the placebo group (24.0 mmHg, 19.4-30.5) but there was no difference in the distal contractile integral (DCI) and the peristaltic pattern (intact peristalsis, weak peristalsis with small or large break, others (failed peristalsis or premature contraction, rapid contraction) between the groups. In 14 subjects with peristaltic abnormality, defined as intact peristalsis of less than 80%, there was no difference in the DCI between the groups but in the acotiamide group there was a significant improvement in the basal LES pressure (acotiamide: 23.7 mmHg, (21.4-28.9), placebo: 21.9, (16.8-24.4), p=0.0383), and the peristaltic pattern (acotiamide: intact peristalsis 52.1%, small defect 21.4%, large defect 19.3%, others 7.1%, placebo:

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AGA Abstracts

AGA Abstracts

disease (GERD)-related sleep disturbances. The results at study endpoint (4 weeks) have shown that esomeprazole was effective in relieving nighttime HB and improving sleep quality and work productivity.1,2 Given that the regimen is likely to be available over-the-counter (with up to 14-day-use labeling) in 2014, results from subjects receiving esomeprazole 20 mg or placebo during the first 14 days are reported. Methods: Adults with a history of frequent nighttime HB and GERD-related sleep disturbances were eligible for inclusion; those with other conditions possibly contributing to sleep disturbance were excluded. Following a 7-day run-in period, subjects with moderate-to-severe nighttime HB and associated sleep disturbance on ≥3 of 7 days were randomly assigned to double-blind, once-daily treatment with esomeprazole or placebo. The current report includes data from the first 14 days for subjects receiving esomeprazole 20 mg or placebo. The occurrence of GERD-related sleep disturbance and the frequency/severity of HB episodes were recorded by subjects in a daily self-assessment diary. Efficacy outcomes included complete resolution of GERD-related sleep disturbance (no sleep disturbance on 7 consecutive days) and relief (no more than 2 nights with sleep disturbance in 7 consecutive days) and HB resolution (no HB on 7 consecutive days during the preceding week). The proportion of subjects with relief/resolution at weeks 1 and 2 of treatment was compared using a chi-square test. Survival analysis was performed on the days to first resolution of sleep disturbance (defined as first day patient responded "no" to sleep disturbance question). Results: The efficacy analysis set for study 1 and 2 included 441 and 262 subjects, respectively. Baseline demographics and clinical characteristics were well balanced between the treatment groups. Results for both studies (Table) demonstrated that a significantly higher proportion of subjects treated with esomeprazole 20 mg had relief/resolution of GERD-related sleep disturbances and resolution of nighttime, daytime, and 24-h HB in weeks 1 and 2 of treatment. Conclusion: In this population of subjects with a history of frequent nighttime HB and GERD-related sleep disturbances, a 14-day regimen of esomeprazole 20 mg once daily was significantly more effective than placebo in resolving HB symptoms and associated sleep disturbances, with improvements in sleep occurring as early as the first 2 nights in the majority of subjects. Ref: 1. Johnson DA, et al. Am J Gastroenterol. 2005;100:1914-22. 2. Johnson D, et al. Aliment Pharmacol Ther. 2010;32:182-90. Efficacy Outcomes With 14-Day Treatment With Esomeprazole 20 mga or Placebo