International, Prospective, Observational, Multicenter Registry on the Management of Acute Diarrhea in Children (REMAD)

International, Prospective, Observational, Multicenter Registry on the Management of Acute Diarrhea in Children (REMAD)

receiving ASA or placebo, and observational studies of patients taking low-dose ASA. Studies were excluded if any of the following applied: ASA dose >...

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receiving ASA or placebo, and observational studies of patients taking low-dose ASA. Studies were excluded if any of the following applied: ASA dose >325 mg/day, ASA dose not reported, or all participants given concomitant gastroprotective therapy or Helicobacter pylori eradication therapy. Results. Searches identified 3013 studies, 15 of which were eligible for inclusion. The most commonly reported risk factor for UGIB in low-dose ASA users was a history of peptic ulcer disease (see Figure), which was reported in six studies (n = 3353). Five of the six studies reported relative risks (RRs) or odds ratios (ORs) of 3.1-6.5 when assessing this relationship, while the sixth reported a much higher OR of 15.2 (95% confidence interval [CI]: 3.8-60.1). Other factors significantly and consistently associated with the risk of UGIB in users of low-dose ASA were: current H. pylori infection (1 study; OR: 4.69; 95% CI: 2.02-10.91), concomitant calcium channel blocker use (1 study; OR: 2.53; 95% CI: 1.255.14), concomitant clopidogrel use (1 study; RR: 1.90; 95% CI: 1.12-3.22), increasing ASA dose (1 study; RR: 1.8; 95% CI: 1.5-6.5), and a history of dyspepsia (1 study; RR: 1.77; 95% CI: 1.20-2.61). Three studies found that proton pump inhibitor (PPI) use was associated with a significant reduction in the risk of UGIB in users of low-dose ASA (OR: 0.02, OR: 0.086 and RR: 0.56). Conclusions. Relatively few studies have examined potential risk factors for UGIB in users of low-dose ASA. The studies that have been performed show that the risk of UGIB is increased in low-dose ASA users who have a history of peptic ulcer disease, H. pylori infection or dyspepsia, or who are also taking calcium channel blockers or clopidogrel. Increasing ASA dose is also associated with an increased risk of UGIB. In contrast, patients taking PPIs alongside their low-dose ASA have a reduced risk of UGIB.

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infection who have prior ulcer bleeding, the long-term risk of recurrent ulcer bleeding with ASA use is not significantly different from that of average-risk ASA users. Drug exposure (patient-years) and primary outcome (Ulcer bleeding) in the two cohorts according to drugs combinations

IRR, incidence rate ratio; CI, confidence interval. 1053 Aspirin CV/GI Risk Calculator, a Tool to Help Physicians to Decide Prescription in Clinical Practice Angel Lanas, Mónica Polo-Tomás, Ruben Casado-Arroyo Background: The cardiovascular (CV) benefits of low-dose aspirin (LDA) are offset by its association with upper gastrointestinal complications (UGIC), which is variable and depends on the presence of risk factors. In some patients the GI risk of LDA may overcome the CV benefits; co-therapy with PPI has been recommended for at-risk patients to reduce UGIC. However, the assessment of both GI and CV risks and the benefits of LDA for any individual patient may be difficult in clinical practice. Aim: To develop a tool to estimate the CV and GI risks for any individual patient and to facilitate the clinical decision process. Methods: Based on the most updated publications we have constructed risk ratios estimations and incidence of CV and UGIC events according to the presence of different risk factors. For CV risks we have used Framingham's 10 year-risk estimations (Wilson, D'Agostino, Levy et al. Circulation 1998) and assumed a 15-20% CV risk reduction with ASA depending on basal risk. Clopidogrel on top of LDA reduced that risk a further 8%. For UGIC we assumed a baseline incidence of 1 case per 1000-persons-year and considered the following risk factors (age, male sex, complicated ulcer history, uncomplicated ulcer history, dyspepsia and concomitant use of NSAID use, warfarin/dicumarinics or clopidogrel). LDA increased UGIC risk by a factor of 2 and estimated a 60% GI risk reduction with PPI co-therapy and another 60% with H. pylori eradication in patients with peptic ulcer history. Access to this CV/GI risk calculator is available at http://servidor1.azormultimedia.es/calculadora/index.php Results: Table 1 contains 4 examples of a 70 years old male with different GI and CV risks where the number of UGIC events associated with LDA use overcome the CV benefits, as well as the effects of PPI co-therapy or HP eradication. Many other cases can be tested online. Conclusions: There are many clinical conditions where the number of UGIC induced by LDA exceeds the number of CV events prevented. An ASA CV/GI risk calculator for use in clinical practice should help and guide physicians to choose the most appropriate prescriptions. CV/GI events saved/ induced by LDA and co-therapy in 10 years time

Figure. Number of studies reporting various risk factors for upper gastrointestinal bleeding in users of low-dose acetylsalicylic acid. 1055 International, Prospective, Observational, Multicenter Registry on the Management of Acute Diarrhea in Children (REMAD) Francisco Guarner, Margarita Murrieta-Aguttes, Georgette Daoud, Hugo Laignelet, Alejandra Consuelo

* per 1000 patients-year

Acute diarrhea is a leading cause of morbidity and mortality in children. Prompt and appropriate management prevents complications and reduces health risks. The level of knowledge, use, and availability of therapies to successfully manage acute diarrhea in normal practice is not well known. To this aim, a prospective observational study was carried out in 5 countries: Colombia (22 sites), Guatemala (15 sites), Mexico (22 sites), Venezuela (17 sites), and Egypt (24 sites). Target population: infants/children (6 mo to 6 y of age) presenting with community acquired acute diarrhea at onset. Chronic disease (IBD/IBS), underlying severe malnutrition and immuno-deficiency were excluded. The study consisted of 2 visits, entry and longitudinal visit at 15±1 d. Data retrieval: demography, medical history, physical examination, available laboratory tests, therapeutic measures, incidence of complications, and diarrhea status at end of study (main outcome measure). Results: 1439 children were included (Colombia 258, Guatemala 309, Mexico 300, Venezuela 266, and Egypt 306) during a 12-month enrollment period and 1388 completed the study. At entry, 53.4%

1054 Risk Factors for Upper Gastrointestinal Bleeding in Patients Using Low-Dose Acetylsalicylic Acid: A Systematic Literature Analysis Ernst J. Kuipers, Catherine Hill Introduction. Low-dose acetylsalicylic acid (ASA) is recommended for secondary prevention of cardiovascular events. However, its use is also associated with an increased risk of upper gastrointestinal bleeding (UGIB). This study aimed to assess systematically the risk factors for UGIB in users of low-dose ASA. Methods. A systematic review of PubMed was performed (to August 2010) to identify randomized controlled trials reporting UGIB in individuals

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cases and were associated with adverse events in 16/49 (32%) cases: 8 (17%) premature deliveries (<37 GW) of children born alive, 3 (6%) deaths (2 deaths in utero, 1 extreme prematurity), 1 HELLP syndrome, 2 gestational cholestasis, 1 maternal infection, 1 colectomy for severe UC. In the group of complicated pregnancies, 5/16 (31%) patients were in relapse at the time of conception vs. 27% among the normal pregnancies group. Among the 46 infants alive, 7 (15%) presented 10 neonatal complications, namely 6 (13%) foetal hypotrophy (birth weight <2500g), 3 respiratory distress syndromes and 1 foetal infection. Median birth weight was 3.1kg (1.9-3.78) and median birth size was 49cm (43-52). CONCLUSION These interim results suggest that one third of pregnancies exposed to anti-TNF agents are complicated. These data do not seem to differ from those reported in the IBD population, suggesting an absence of excess risk linked to anti-TNF therapy. Based on the number of patients currently collected, the results for at least 125 births under anti-TNF will be available by May 2011. 1058 Clinical Presentation of Acute Diverticulitis: Most Patients Do Not Fulfill the Classic Triad of Pain, Fever, and Leukocytosis Victoria Sheen, Nikhil Agarwal, Poyrung Poysophon, Bradley J. Snyder, Marc Kaneshiro, Mary A. Atia, Janet Yang, Roger E. Bolus, Brennan M. Spiegel Background: Although acute diverticulitis is highly prevalent, there is surprisingly little published about how patients initially present with this condition. Textbooks and guidelines emphasize the classic diverticulitis “triad” of abdominal pain, fever, and leukocytosis. However, the true prevalence of this triad has not been described, nor have the combinations of its individual components. It is possible that many patients do not present with the full triad, and that diagnosis requires a lower threshold. If true, this would pose a diagnostic challenge in both ambulatory and inpatient settings. We sought to elucidate the clinical parameters that characterize confirmed attacks of acute diverticulitis. Methods: We performed a retrospective analysis of detailed medical records to measure clinical characteristics of patients presenting to a University-based VA medical center from 1996-2010 with CTconfirmed diverticulitis. We gathered data on patient demographics, body mass index (BMI), symptom duration, presence of abdominal pain, location of diverticulitis on CT scan, presence of fever (temp >38 C), presence of leukocytosis (WBC>11K), and left shift (%PMN>85) at the time of initial presentation. We calculated descriptive statistics for the population, compared profiles between inpatients and outpatients using bivariate statistics, and created a Venn diagram to demonstrate the overlap of pain, fever, and leukocytosis (triad), along with the expanded triad including a left shift. Results: There were 173 patients in the analysis (mean age=57.8; 93% male; mean BMI=29.1). 60% were managed as inpatients; others were managed in the clinic or emergency room without hospitalization. 91% had left-sided (sigmoid or descending) diverticulitis on CT. Abdominal pain was present in 99% on initial presentation, of which 82% was left lower quadrant. The initial mean temp was 36.8 C, and the mean WBC count was 12.5K. The triad of concurrent abdominal pain, fever, and leukocytosis was evident in only 4% on initial presentation; when also requiring a left shift, no patients met the expanded triad (Figure). There were no statistically significant differences in the clinical parameters between inpatients and outpatients. Conclusions: Contrary to traditional teaching, very few patients with CT-confirmed acute diverticulitis fulfill the classic triad of abdominal pain, fever, and leukocytosis (4% in this series), and no patients met the expanded triad also requiring a left-shift. Although individual components of the triad are common, their convergence should not be required to suspect diverticulitis - lower clinical thresholds must be employed. This has implications not only for clinical practice, but also for clinical trials that must define inclusion criteria for diverticulitis (i.e. FDA currently emphasizes presence of the triad, independent of CT findings).

1056 Prevalence of Abdominal Pain and Functional Gastrointestinal Disorders in Community Children Silvana Bonilla, Ashish Chogle, Miguel Saps Functional gastrointestinal disorders are common in children. Abdominal pain is the most common gastrointestinal symptom in children. The severity of abdominal pain drives medical consultations and quality of life in adult patients with IBS. Thirty-eighth percent of 8 to 15 year old school children report abdominal pain weekly with 24% of those children reporting persistence of abdominal pain for more than 8 weeks. Despite the high prevalence of abdominal pain, only 2% of school children seek medical attention for abdominal pain. The various factors influencing consultation for abdominal pain in children are not completely understood. Lack of parental knowledge on their child's symptoms may constitute one of the factors affecting the low ratio of consultation in children reporting abdominal pain. AimsTo determine the prevalence of abdominal pain and functional gastrointestinal disorders in healthy community children by parental report. Methods-Data of 4 different studies that used the same methodology to assess gastrointestinal symptoms in children with celiac disease, cow's milk allergy, pyloric stenosis and Henoch-Schönlein purpura and their healthy siblings were reviewed for parents' answers to: 1- a phone questionnaire on the presence of gastrointestinal symptoms and; 2- Pediatric Gastrointestinal Symptoms Rome III version questionnaire (QPGS-RIII). Inclusion criteria included healthy children 4-18 years of age and the presence of a sibling who was previously diagnosed with celiac disease, cow's milk allergy, pyloric stenosis or Henoch-Schönlein purpura. Exclusion criteria: Non-verbal children and non-English speaking. Results- We obtained data on 191 healthy children, mean age (7.4 years, range 3-24, 111 boys). Parents reported presence of AP in the last 8 weeks in 16 (8.3%) children (age range 4-18 years, 8 girls). There was no significant difference in abdominal pain prevalence between boys and girls (p=0.72). Seven children met the QPGS-RIII diagnostic criteria for a functional gastrointestinal disorder: 6 Functional Abdominal Pain, 1 IBS, and 9 were not classifiable by Rome III criteria. ConclusionsAbdominal pain was common in community children. Functional Abdominal Pain was the most common functional gastrointestinal disorder among healthy community children. Prevalence of abdominal pain by parental report is lower than the previously published prevalence of abdominal pain reported by the children. Lack of awareness of children's symptoms may play a role in the low ratio of consultation for abdominal pain in symptomatic children. Future prospective studies should confirm our findings and investigate the factors influencing the medical consultation decision including parental awareness of children's symptoms. 1057 Anti-TNF Therapy and Pregnancy in Inflammatory Bowel Disease: A Prospective Cohort Study From the GETAID Mariam Seirafi, Xavier Treton, Benedicte De Vroey, Jacques Cosnes, Xavier Roblin, Matthieu Allez, Philippe Marteau, Martine De Vos, Mathurin Flamant, David Laharie, Guillaume Savoye, Laurent Peyrin Biroulet, Brixi-Benmansour Hedia, Nicolas Mathieu, Yoram Bouhnik AIM Few studies have been conducted on the risks of exposure to anti-TNFs before or during pregnancy, therefore current recommendations are based on limited evidence. The aim of this study was to assess the impact of treatments with anti-TNFs on foetal development and pregnancy outcome. PATIENTS AND METHODS Pregnancies occurring during antiTNF treatment or less than 3 months after withdrawal of it in patients with IBD followed in GETAID centres, were recorded from January 2009 and are planned to be recorded until December 2010. Dosage and duration of exposure to anti-TNFs and associated treatments were recorded. Disease activity as well as maternal-foetal, obstetrical and neonatal complications were ascertained. RESULTS Until November 2010, 127 pregnancies were recorded in 120 patients, of whom 85 (65CD, 18UC, 2 IC) were fully documented in 81 patients (median age 28 years). Among them, 6/85 (7%) miscarriages occurred, 49/85 (58%) pregnancies were carried to term and resulted in 47 live births, 30/85 (35%) pregnancies are ongoing. At conception, 23/85 (27%) patients were in relapse and 62/85 (73%) in clinical remission. Thirteen/62 (21%) patients in remission at the time of conception experienced flares during pregnancy. The anti-TNFs used were infliximab, adalimumab and certolizumab in 63% (54/ 85), 34% (29/85) and 2% (2/85). Immunosuppressants were given in association in 16% (14/85) of cases (AZA=11, 6-MP=3). The median duration of anti-TNF treatment at the time of conception was 357 days. Of the 49 completed pregnancies, anti-TNFs were preventively interrupted in 31/49 (63%) patients at the end of 6th gestational month and pursued until delivery in 14/49 (29%) patients. Completed pregnancies were uneventful in 33/49 (67%)

Overlap Among Pain, Fever, Leukocytosis, and Left Shift in 173 Patients Presenting with CT-Confirmed Acute Diverticulitis (Triad=Pain+Fever+Leukocytosis; Expanded Triad= Triad+Left Shift). 1059 Cost-Effectiveness Analysis of Azathioprine vs. Infliximab vs. Combination Therapy for Crohn's Disease Andrew R. Reinink, Martin Gregory, Steven Kymes, Themistocles Dassopoulos Background and Aims: Immunomodulators, most commonly azathioprine in the United States, have been mainstay therapy for Crohn's disease. The anti-TNF biologics are more potent, but drug costs are an order of magnitude higher. Earlier cost-effectiveness analyses were limited by the lack of data from randomized trials comparing the different treatment strategies. Using data from the recently completed SONIC trial, which compared azathioprine monotherapy, infliximab monotherapy and azathioprine-infliximab combination therapy,

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presented vomits, 38.1% dehydration, and 10.6% blood in stools, without significant difference among countries. In 77.3%, laboratory tests were performed. Etiology was 51.1% viral, 22.7% bacterial, 12.9% parasitological, 1.5% antibiotic-induced or 16.1% other/unknown. Bacterial etiology was higher in Egypt (33.1%), and parasitological cause in Venezuela (23.7%). In American countries, oral rehydration (86.9%), probiotics (80.6%), antipyretics (33.5%), antibiotics (19.5%), antiemetics (16.1%) and antidiarrheals (6.5%) were prescribed at entry. In Egypt, therapeutic pattern differed markedly: oral rehydration (54.2%), probiotics (22.5%), antipyretics (61.8%), antibiotics (39.5%), antiemetics (56.2%) and antidiarrheals (60.5%). Remission of diarrhea was confirmed at longitudinal visit in 92.3% of children, without clear difference among countries (range 89.9% to 96.7%). Prescription of antibiotics at entry was significantly associated with persistence of diarrhea (Odds Ratio 1.64, CI 1.092.49; p=0.018) and incidence of clinical complications (OR 1.60, CI 1.13-2.26; p=0.007) at longitudinal visit, whereas prescription of probiotics was associated with reduced risk of diarrhea persistence (OR 0.56, CI 0.38 to 0.83; p=0.003) and clinical complications (OR 0.64, CI 0.46 to 0.88; p=0.006). Overall, 90% of physicians claimed using recommended guidelines. Conclusions: Therapeutic strategies for acute diarrhea in children differed among countries, but there were no significant differences in achieving remission. Use of antibiotics as initial treatment in this population suffering mainly from viral diarrhea was significantly associated with poor outcome whereas use of probiotics was associated with improved outcome.