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Background Capsule endoscopy (SBCE) has developed a relevant role in patients with established Crohn's Disease (CD). However, evaluation of the impact in clinical management has been scarce. Aims To evaluate therapeutic impact of SBCE in an 11-year real-life cohort of known CD patients. Methods Retrospective single center study including all patients with established CD submitted to SBCE procedure from 01/01/2008 to 31/12/2019. Patency capsule was used in selected patients. Small bowel mucosal inflammation was quantified using Lewis score. Therapeutic impact was defined as a change in CD-related treatment recommended based on SBCE results. Patients were assigned to four groups regarding SBCE indication: staging, flare, post-op and remission. Results From the 432 SBCE performed 87.5% were conclusive. Active disease was present in 63.7 of patients; 41.6% mild inflammation and 21.9% moderate-to-severe activity. A change of management was guided by SBCE in 51.3% of procedures: 199 (46.1%) escalation and 23 (5.3%) de-escalation, with significant changes in all groups. Escalation increased with disease activity: 57.8% in mild and 89.5% in moderate-to-severe disease. De-escalation was conducted in 13.9% procedures with mucosal healing and 1.1% with mild disease. Conclusion SBCE is a useful tool for guiding therapeutic management in CD patients both for treatment escalation and de-escalation.

INTRODUCTION Knowing the natural history of ulcerative colitis (UC) is essential to understand the course of the disease, assess the impact of different treatment strategies and identify poor prognostic factors. One of the most significant matters in this regard is the need for surgery. OBJECTIVES To analyse the Colectomy Incidence Rate (CIR) from diagnosis to end of follow-up (31/12/2017) and identify predictive factors for colectomy. MATERIAL AND METHODS A retrospective study enrolling patients with a definitive diagnosis (DD) of UC or Unclassified Colitis (UnC) in the 2001-03 Navarra cohort. RESULTS We enrolled 174 patients with a DD of UC (E2 42.8%; E3 26.6%) and 5 patients with a DD of UnC: 44.1% women, median age 39.2 years (range 7-88) and median follow-up 15.7 years. A total of 8 patients underwent surgery (CIR 3 colectomies/103 patient-years: 3 at initial diagnosis (

Resumen Introduccion La capsula endoscopica de intestino delgado (CEID) es una tecnica diagnostica poco invasiva cuyo empleo en la enfermedad inflamatoria intestinal (EII) se ha extendido. Se ha desarrollado recientemente una capsula panenterica, PillCamCrohn's (PCC). Carecemos de informacion sobre la disponibilidad y el uso de la CEID y la PCC en nuestro medio. Metodos Realizamos una encuesta electronica y anonima entre los miembros del Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa y la Asociacion Espanola de Gastroenterologia consistente en 37 preguntas de respuesta multiple. Resultados Participaron 150 miembros, la mayoria con dedicacion especial a la EII (69,3%). El 72,8% trabajaban en centros con unidad de EII. El 79% tenian la CEID disponible en su hospital, y el 14% la derivaban a otro centro. El 22% tenian disponible la PCC, y el 9% la derivaban a otro centro. El 79,3% de encuestados con CEID disponible la utilizaban en un pequeno porcentaje de pacientes con EII y el 15,6% en la mayoria. Los escenarios mas frecuentes fueron la sospecha de enfermedad de Crohn (76,3%), la valoracion de actividad inflamatoria (54,7%) y la evaluacion de la extension de la enfermedad (54,7%). Mas de la mitad (59,7%) utilizaban preferentemente la capsula Patency® para valoracion de la permeabilidad intestinal. Casi todos los encuestados (99,3%) consideraban que se deberian implementar recursos formativos en esta tecnica. Conclusiones La CEID cuenta con una amplia disponibilidad en los hospitales espanoles para el manejo de la EII, si bien su uso es todavia limitado. Existe una oportunidad para aumentar la formacion en esta tecnica, y, con ella, su empleo.

Background The long-term outcome of patients after antitumour necrosis factor alpha (anti-TNF) discontinuation is not well known. Aims To assess the risk of relapse in the long-term after anti-TNF discontinuation. Methods This was an extension of the evolution after anti-TNF discontinuation in patients with inflammatory bowel disease (EVODIS) study (Crohn's disease or ulcerative colitis patients treated with anti-TNFs in whom these drugs were withdrawn after achieving clinical remission) based in the same cohort of patients whose outcome was updated. Clinical remission was defined as a Harvey-Bradshaw index ≤4 points in Crohn's disease, a partial Mayo score ≤2 in ulcerative colitis and the absence of fistula drainage despite gentle finger compression in perianal disease. Results This was an observational, retrospective, multicenter study. A total of 1055 patients were included. The median follow-up time was 34 months. The incidence rate of relapse was 12% per patient-year (95% confidence interval [CI] = 11-14). The cumulative incidence of relapse was 50% (95% CI = 47-53): 19% at one year, 31% at 2 years, 38% at 3 years, 44% at 4 years and 48% at 5 years of follow-up. Of the 60% patients retreated with the same anti-TNF after relapse, 73% regained remission. Of the 75 patients who did not respond, 48% achieved remission with other therapies. Of the 190 patients who started other therapies after relapse, 62% achieved remission with the new treatment. Conclusions A significant proportion of patients who discontinued the anti-TNF remained in remission. In case of relapse, retreatment with the same anti-TNF was usually effective. Approximately half of the patients who did not respond after retreatment achieved remission with other therapies.

Ustekinumab (UST) is a monoclonal antibody against IL-12/23 approved in Spain (2017) to treat moderate / severe Crohn's disease.To evaluate the effectiveness and safety in real clinical practice in patients treated with UST in our center.This is a prospective observational study including patients who started UST from 08/01/2017 to 02/28/2019 with follow-up up to that date. We analyze response and remission in weeks 16, 24 and 52, using "Crohn's Disease Activity Index" (response if 100 point decrease and remission if150) and Physician's Global Assessment.We included 61 patients with a median duration of Crohn's disease of 14,6 years (0-36). The 83,6% of patients without steroids and 73,8% without associated immunosuppressors. Previously all patients had received anti-TNF and 14,8%, in addition, vedolizumab. We observed a good correlation between Crohn's Disease Activity Index and Physician's Global Assessment (r = 0,89, p.001). In week 16 (n = 45) 75,6% response (57,8% remission), in week 24 (n = 35) 69,9% response (45,7% remission) and in week 52 (n = 12) 75% response (58.3% remission). There were no statistically significant differences in the response/remission rates at week 16 or 24 depending on the reason for the onset of UST or the number of previous biologics. In 2 patients it was withdrawn due to toxicity (arthralgia / myalgia).UST is an effective and safe treatment in real clinical practice with high rates of clinical remission at week 16, 24 and 52 regardless of the order of biological used and the reason for starting UST.

Resumen Introduccion Ustekinumab (UST) es un anticuerpo monoclonal frente a IL-12/23 aprobado en Espana (2017) para tratar el brote moderado/grave de enfermedad de Crohn. Objetivo Evaluar la efectividad y seguridad en practica clinica real en los pacientes tratados con UST en nuestro centro. Metodos Estudio prospectivo observacional unicentrico incluyendo los pacientes que iniciaron UST desde el 1/08/2017 hasta el 28/02/2019 con seguimiento hasta esa fecha. Analizamos respuesta y remision en semanas 16, 24 y 52, utilizando «Crohn's Disease Activity Index» (respuesta si descenso de 100 puntos y remision si Resultados Incluimos 61 pacientes con una mediana de duracion de enfermedad de Crohn de 14,6 anos (0-36). El 83,6% sin esteroides y el 73,8% sin inmunosupresores asociados. Previamente todos habian recibido anti-TNF y el 14,8%, ademas, vedolizumab. Observamos buena correlacion entre Crohn's Disease Activity Index y Valoracion Global del especialista (r = 0,89, p Conclusion UST es un farmaco eficaz y seguro en practica clinica real con altas tasas de remision clinica en semana 16, 24 y 52 independientemente del orden de biologico utilizado y del motivo de inicio de UST.

Resumen Introduccion CT-P13 es un farmaco biosimilar de infliximab (IFX), efectivo en pacientes con enfermedad inflamatoria intestinal (EII). La medicion de niveles de IFX y anticuerpos anti-IFX forma parte del tratamiento integral de dicha enfermedad. Objetivo Comparar la respuesta clinica en funcion de un abordaje estrictamente clinico (CLN) o proactivo (PRO) basado en la medicion de niveles en la semana 14, en la practica clinica. Metodos Estudio prospectivo en pacientes que inician CT-P13 por EII. En el grupo PRO se midieron sistematicamente los niveles de IFX y de anticuerpos postinduccion (semana 14) y se intensificaron aquellos con niveles infraterapeuticos ( Resultados Se incluyeron 77 pacientes (23 colitis ulcerosa y 54 enfermedad de Crohn). Ambos grupos, PRO (n = 41) y CLN (n = 36) presentaron una eficacia inicial y a largo plazo sin diferencias significativas. En la semana 14 hubo un 61% de remision clinica (RC) (58,5% PRO, 63,9% CLN) y un 80,5% de al menos respuesta parcial (RP) (80,5% PRO, 80,6% CLN). En la semana 54 hubo un 68,8% de RC (61% PRO, 77,8% CLN) y un 76,6% de al menos RP (73,2% PRO, 80,6% CLN). De los pacientes en RC en la semana 14 (24 PRO, 23 CLN), 13 del grupo PRO fueron intensificados por niveles infraterapeuticos. En este subgrupo no se observaron diferencias significativas en la perdida de respuesta secundaria (PRO 0%, CLN 8,7%). Conclusion Un manejo proactivo no mejoro las tasas de respuesta ni la remision en el primer ano. La intensificacion de pacientes en RC y niveles infraterapeuticos postinduccion no parece prevenir de forma significativa la perdida de respuesta secundaria en el primer ano.

Pyoderma gangrenosum is a difficult to manage ulceronecrotising dermatosis associated with inflamatory bowel disease. In this article, we report a pyoderma gangrenosum associated with severe ulcerative colitis refractory to different treatments that finally responded to tofacitinib with complete remission of both digestive symptoms and pyodermical lesions. This case is an indicator of the potential role of tofacitinib for the treatment of extraintestinal manifestations of inflamatory bowel disease.

Small bowel capsule endoscopy (SBCE) is a non-invasive diagnostic technique whose use in inflammatory bowel disease (IBD) has spread. A panenteric capsule, PillCam Crohn's (PCC), has recently been developed. We lack information on the availability and use of the CEID and PCC in our environment.We conducted an electronic and anonymous survey among the members of the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) [Spanish Working Group on Crohn's Disease and Ulcerative Colitis] and the Asociación Española de Gastroenterología (AEG) [Spanish Association of Gastroenterology], consisting of 37 multiple-choice questions.One hundred and fifty members participated, the majority dedicated to IBD (69.3%). 72.8% worked at centres with an IBD unit. 79% had SBCE available at their hospital, 14% referred patients to another centre; 22% had a PCC available, 9% referred patients to another centre. 79.3% of respondents with available SBCE used it in a small percentage of patients with IBD and 15.6% in the majority. The most frequent scenarios were suspicion of Crohn's disease (76.3%), assessment of inflammatory activity (54.7%) and assessment of the extent of the disease (54.7%). More than half (59.7%) preferentially used the Patency capsule to assess intestinal patency. Almost all respondents (99.3%) considered that training resources should be implemented in this technique.SBCE is widely available in Spanish hospitals for the management of IBD, although its use is still limited. There is an opportunity to increase training in this technique, and consequently its use.

Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

Knowing the natural history of ulcerative colitis (UC) is essential to understand the course of the disease, assess the impact of different treatment strategies and identify poor prognostic factors. One of the most significant matters in this regard is the need for surgery.To analyse the Colectomy Incidence Rate (CIR) from diagnosis to end of follow-up (31/12/2017) and identify predictive factors for colectomy.A retrospective study enrolling patients with a definitive diagnosis (DD) of UC or Unclassified Colitis (UnC) in the 2001-03 Navarra cohort.We enrolled 174 patients with a DD of UC (E2 42.8%; E3 26.6%) and 5 patients with a DD of UnC: 44.1% women, median age 39.2 years (range 7-88) and median follow-up 15.7 years. A total of 8 patients underwent surgery (CIR 3 colectomies/103 patient-years: 3 at initial diagnosis (1 month), 2 in the first 2 years, 2 at 5 years from diagnosis and 1 at 12 years from diagnosis. All had previously received steroids; 5 had received immunomodulators and 2 had received biologics. In 7 patients (87%), surgery was performed on an emergency basis. The indication was megacolon in 3 (37.5%), severe flare-up in 3 (37.5%) and medical treatment failure in 2 (25%). In 5 cases (62.5%), an ileoanal pouch was made, and in 3 cases, a definitive ileostomy was performed. In the univariate analysis, patients with loss of more than 5 kg at diagnosis and admission at diagnosis had a lower rate of colectomy-free survival.In our series, colectomy rates are lower than usually reported. Most colectomies were performed in the first 5 years following diagnosis and had an emergency indication.

Background Tacrolimus is a calcineurin inhibitor commonly used for prophylaxis of rejection in renal and liver transplantation. There are limited but favourable data regarding its possible use in patients with inflammatory bowel disease (IBD). Aims To evaluate the efficacy and safety of tacrolimus in patients with IBD in clinical practice. Methods We performed a retrospective, multicentre study in 22 centres in Spain. All adult patients who received oral tacrolimus for luminal or perianal IBD were included. Clinical response was assessed by Harvey-Bradshaw index and partial Mayo score after 3 months. Perianal disease was evaluated by fistula drainage assessment. Results One hundred and forty-three patients were included (mean age 38 years; 51% male; median disease duration 110 months). In ulcerative colitis (UC) (n = 58), the partial Mayo score decreased after 3 months from median 6 to 3 (P = 0.0001), whereas in Crohn's disease (CD) (n = 85), the Harvey-Bradshaw index decreased after 3 months from median 9 to 7 (P = 0.011). In CD patients, blood tacrolimus concentrations during induction (>10 ng/mL vs

Aim To assess the likelihood of detecting latent tuberculosis infection [LTBI] by the positive conversion of a serial tuberculin skin test [TST] at 1 year in inflammatory bowel disease [IBD] patients with negative baseline two-step TST. Methods In this multicentre prospective cohort study, we evaluated rate and predictors of conversion of TST at 1 year in patients with negative baseline TST. We also evaluated management of patients who had a positive TST at baseline or a conversion at 1 year. In all patients we assessed TB cases occurring during follow-up. Results Of the 192 IBD patients receiving anti-tumour necrosis factor [TNF] and 220 IBD controls not receiving anti-TNF, 35 [8.5%, 95% CI 5.7-11.3] had positive conversion (median TST induration 13 mm, interquartile range [IQR] 9-16). Ten anti-TNF cohort patients [5.2%, 95% CI 2.5-9.5] versus 25 controls [11.4%, 95% CI 7.5-16.3] had TST conversion [p = 0.029]. In multivariate analysis, conversion was associated with smoking habit (odds ratio [OR] 2.19, 95% CI 1.08-3.97; p = 0.028). Anti-TNF-treated patients had a lower conversion rate [OR 0.41, 95% CI 0.20-0.83; p = 0.013]. The likelihood of conversion correlates with fewer immunosuppressive therapies between baseline TST and TST at 1 year [p = 0.042]. One case of active TB [isoniazid-resistant strain] occurred in a patient with positive baseline TST receiving anti-TNF [0.05 events/100 patient-years]. Conclusions Serial TST at 1 year can detect LTBI in IBD patients receiving anti-TNF therapy with negative baseline TST. Serial TST seems to be advisable to reduce the risk of TB cases associated with inability to detect LTBI in pre-treatment screening.

Introduction CT-P13 is a biosimilar drug of infliximab (IFX), effective in patients with inflammatory bowel disease (IBD). The monitoring of levels of IFX and anti-IFX antibodies is now considered part of the integral management. Objective To compare the clinical response according to a strictly clinical (CLN) or proactive (PRO) approach based on the monitoring of levels in week 14, in clinical practice. Methods We conducted a prospective study in IBD patients starting CT-P13. In the PRO group, levels of IFX and post-induction antibodies were systematically measured (week 14) and those with infraterapeutic levels ( Results We included 77 patients (23 ulcerative colitis and 54 Crohn's disease). Both PRO (n = 41) and CLN (n = 36) groups showed initial and long-term efficacy without significant differences. At week 14, 61% clinical remission (CR) (58.5% PRO, 63.9% CLN) and 80.5% at least partial response (PR) (80.5% PRO, 80.6% CLN). In week 54, 68.8% CR (61% PRO, 77.8% CLN) and 76.6% at least PR (73.2% PRO, 80.6% CLN). Of the patients in CR in week 14 (24 PRO, 23 CLN), 13 of the PRO group were intensified due to infra-therapeutic levels. In this subgroup no significant differences were observed in secondary loss of response (PRO 0%, CLN 8.7%). Conclusion Proactive management does not improve response or remission rates in the first year. The intensification of clinical remission patients with post-induction infratherapeutic levels does not seem to significantly prevent secondary loss of response in the first year.

Aim: To evaluate outcomes of early dose optimization of golimumab in ulcerative colitis (UC) patients with inadequate response to golimumab induction treatment.Methods: This observational, multicenter, cohort study included patients with moderate-to-severe active UC and with inadequate response to subcutaneous golimumab induction doses, in whom weight-based golimumab maintenance dose (European labeling) of 50mg every 4weeks (q4wk) was optimized before week 14 to 100mg q4wk. At week 14, we assessed clinical response and remission using the partial Mayo score. In the long term we evaluate the cumulative probabilities of golimumab failure-free survival and colectomy-free survival.Results: A total of 209 patients who received golimumab induction doses were eligible. Of these, 151 patients (72.2%) weighing less than 80kg were assigned to a golimumab maintenance dose of 50mg q4wk. Twenty-four patients (15.9% [12.5% overall]), in whom scheduled doses of 50mg q4wk were optimized to 100mg q4wk before week 14, compose the study population. At week 14, 16 patients (66.7%, 95% CI 45.7-87.6) had clinical response, of these 12 were corticosteroid free. Four patients (16.7%) achieved corticosteroid-free remission. After a median follow-up of 12months (IQR 10-22), 13 patients (54.2%) maintained clinical benefit. Thirteen of 16 patients (81.2%) with clinical response at week 14 maintained clinical benefit at last follow-up. All patients avoided colectomy. In none of the patients was golimumab dose de-escalated. There were no adverse events leading to golimumab withdrawal.Conclusion: Early optimization of golimumab dose induces clinical response at week 14 in two thirds of UC patients and leads to long-term clinical benefit in over half of patients.

Background Adalimumab is the second tumour necrosis factor antagonist (anti-TNF) adopted for the treatment of ulcerative colitis. Clinical data from naive patients are scarce. Aim Examine the response to adalimumab in TNF-antagonist-naive patients. Methods This multicentre, observational, prospective study was conducted using a cohort of consecutive patients with ulcerative colitis. Clinical remission, mucosal healing and deep remission were examined employing the Mayo Score and Mayo Endoscopic Score. Clinical response was assessed using the Partial Mayo Score. Results Of 53 individuals included in this study, 49.1% of patients were in clinical remission at week 8 and 60.3%, at week 52. Clinical response was observed in 84.9% and 69.8%, respectively. Mucosal healing was found in 62.3% and 67.9% of the patients, and 43.4% and 58.4% showed deep remission at week 8 and 52, respectively. After a year, 71.7% of the patients continued the adalimumab treatment. Adverse effects were observed in 28.3% of patients. Multivariate analysis showed that the long-term factor predictive of response at week 52 was the response in week 8 (expressed as Mayo Score; OR 0.66; 95% IC 0.1–0.67, p Conclusions Adalimumab treatment of ulcerative colitis is effective; the results are better in clinical practice and in patients naive to anti-TNF.

Resumen En los ultimos anos ha aumentado el numero de pacientes anticoagulados y en consecuencia las complicaciones hemorragicas derivadas de este tratamiento. Analizamos las hemorragias digestivas (HD) por ser las mas frecuentes entre las hemorragias mayores y planteamos que estos sujetos deben presentar lesiones responsables de la HD independientemente de la intensidad de la anticoagulacion, si bien aquellos excesivamente anticoagulados presentaran hemorragias mas graves. Objetivos Estudiar las caracteristicas de los pacientes anticoagulados con HD y la relacion entre el grado de anticoagulacion con el hallazgo de lesiones responsables y la gravedad de la hemorragia. Pacientes y metodos Estudiamos prospectivamente 96 pacientes con HD, anticoagulados con acenocumarol, ingresados consecutivamente entre el 1 de enero de 2003 y el 30 de septiembre de 2005. Se excluyeron aquellos con hepatopatia severa y 9 por faltar datos. Resultados La incidencia de HD fue de 19,6 casos/100.000 habitantes-ano. El 90% de los pacientes presentaron lesiones responsables (85% de las HDA y 50% de las HDB) o potencialmente responsables del sangrado y el 30% requirio tratamiento endoscopico de dichas lesiones sin observarse diferencias en funcion del grado de anticoagulacion. Tampoco se encontraron diferencias en el tipo de lesiones, si bien los pacientes excesivamente anticoagulados presentaron hemorragias mas graves (un 23% de aquellos con un IRN ≥ 4 tuvieron hemorragias con compromiso vital frente a un 4% de los pacientes con un INR Conclusiones Observamos una incidencia 20 HD graves en anticoagulados/100.000 habitantes-ano, sin diferencias ni en el tipo, ni en la frecuencia de lesiones responsables en funcion del grado de anticoagulacion. Los pacientes excesivamente anticoagulados presentan HD mas graves.

Resumen Se ha senalado que las medidas de prevencion en pacientes tratados con antiinflamatorios no esteroideos (AINE) estan infrautilizadas. El objetivo de este estudio es analizar las diferencias entre indicacion y prescripcion real de gastroproteccion con inhibidores de bomba de protones en pacientes con factores de riesgo para complicaciones gastrointestinales en tratamiento con AINE. Metodos Estudio observacional, transversal y multicentrico. Recogida retrospectiva de datos a partir de historias clinicas y cumplimentacion de un cuestionario sobre factores de riesgo e indicacion de gastroproteccion. Resultados Un total de 432 facultativos recogieron datos de 2.160 pacientes tratados con AINE. Un 90,4% de pacientes recibian prescripcion de gastroproteccion con inhibidores de bomba de protones. El tratamiento con AINE a largo plazo frente a corto plazo ( odds ratio =2,37; intervalo de confianza del 95%: 1,779–3,171). La media de factores de riesgo por paciente fue de 2±0,16 (rango: 0–7), se observo una asociacion significativa entre numero de factores de riesgo y porcentaje de pacientes en gastroproteccion. Aun asi, la proporcion de pacientes con factores de riesgo sin gastroproteccion fue del 3% para historia previa de enfermedad ulcerosa o hemorragia digestiva por AINE y del 7–10% para los demas factores. Se observaron diferencias entre indicacion y gastroproteccion prescrita entre las diferentes especialidades, los especialistas de radioterapia son los que presentaron menor grado de gastroproteccion. Conclusiones Estos resultados reflejan que en la practica clinica diaria las diferencias entre indicacion y prescripcion real de gastroproteccion en pacientes con factores de riesgo tratados con AINE son pequenas en nuestro pais.

Summary The VKORC1 c.−1639G>A and CYP2C9 c.430C>T and c.1075A>C polymorphisms have been associated with increased sensitivity to oral anticoagulants. However, their role in gastrointestinal bleeding is unknown. We studied the risk of gastrointestinal bleeding associated with these polymorphisms, and how this risk was influenced by the anticoagulant dose and the use of common drugs. Eighty-nine patients with gastrointestinal bleeding during acenocoumarol therapy and 177 patients free of bleeding during acenocoumarol therapy were studied. None of the three polymorphisms constituted a serious gastrointestinal bleeding risk factor. However, patients bearing at least one of these polymorphisms were at high risk, when they simultaneously met one of the following conditions: a weekly dose of acenocoumarol higher than 15 mg [adjusted Odds Ratio (OR) (95% confidence interval (CI) = 4·19 (1·59–11·04)]; amiodarone use [adjusted OR (95% CI) = 9·97 (1·75–56·89)]; or aspirin use [adjusted OR (95% CI) = 8·97 (1·66–48·34)]. The consumption of statins was associated with a lower risk of gastrointestinal bleeding [adjusted OR = 0·50 (0·26–0·99)]. The risk of gastrointestinal bleeding during acenocoumarol therapy in carriers of any of the studied polymorphisms is severely increased with exposure to weekly doses of acenocoumarol higher than 15 mg or the use of amiodarone or aspirin.

Acute generalized exanthematous pustulosis (AGEP) comprises a group of eruptions characterized by several small sterile pustules over an erythematous-edematous skin. These eruptions are usually drug induced and show some characteristics that suggest an immunologic background. Treatment is based on withdrawal of the drug causing the eruption. Prognosis is generally good and the skin lesions usually resolve in a few days with characteristic postpustular pin-point desquamation. We report three cases of AGEP induced by omeprazole, a drug with a good safety profile. Some adverse cutaneous reactions have been described as secondary effects. However, to our knowledge, no cases of omeprazole-induced AGEP have previously been reported. AGEP related to other proton pump inhibitors is exceptional.

Giardia lamblia is a ubiquitous intestinal protozoan. Transmission, which is fecal-oral, occurs after cyst ingestion, excystation and enterocyte adhesion. Symptoms include diarrhea, abdominal pain and other less frequent manifestations such as nausea, anorexia and weight loss. Enzyme immunoassay and direct fluorescent-antibody assay for antigen detection in stool samples, and small intestine biopsy provide the best diagnostic sensitivity. When an infection is suspected, duodenal biopsy should be carried out, even though endoscopic appearance may be normal. The most effective drugs in the treatment of this infection are metronidazole and tinidazole. We report a case of G. lamblia infection. The patient reported a clinical history of 4 months' duration with general malaise and diarrhea for the previous month. This form of presentation is rarely found in adults with this parasitosis. The diagnosis was based on the results of duodenal biopsy. The patient showed satisfactory response to treatment with metronidazole.

In the last few years, the number of anticoagulated patients has significantly increased and, as a consequence, so have hemorrhagic complications due to this therapy. We analyzed gastrointestinal (GI) bleeding because it is the most frequent type of major bleeding in these patients, and we hypothesized that they would have lesions responsible for GI bleeding regardless of the intensity of anticoagulation, although excessively anticoagulated patients would have more serious hemorrhages.To study the characteristics of anticoagulated patients with GI bleeding and the relationship between the degree of anticoagulation and a finding of causative lesions and bleeding severity.We prospectively studied 96 patients, all anticoagulated with acenocoumarol and consecutively admitted to hospital between 01/01/2003 and 09/30/2005 because of acute GI bleeding. We excluded patients with severe liver disease, as well as nine patients with incomplete details.The incidence of GI bleeding requiring hospitalization was 19.6 cases/100,000 inhabitants-year. In 90% of patients, we found a causative (85% of upper GI bleeding and 50% of lower GI bleeding) or potentially causative lesion, and 30% of them required endoscopic treatment, without differences depending on the intensity of anticoagulation. No relationship was found between the type of lesions observed and the degree of anticoagulation in these patients. Patients who received more intense anticoagulation therapy had more severe hemorrhages (23% of patients with an INR ≥4 had a life-threatening bleed versus only 4% of patients with INR4).We found an incidence of 20 severe GI bleeding episodes in anticoagulated patients per 100,000 inhabitants-year, with no difference in localization or in the frequency of causative lesions depending on the intensity of anticoagulation. Patients receiving more intense anticoagulation had more severe GI bleeding episodes.

Eosinophilic oesophagitis has emerged as a common cause of oesophageal symptoms.To document practice variation in care provided to eosinophilic oesophagitis patients in Spain and to assess adherence to available guidelines.A prospective survey-based registry including data from all patients receiving care from gastroenterologists and allergists throughout Spain was developed.Data from 705 patients (82% adults, male:female ratio 4.1:1) were collected from 26 Spanish hospitals. 42.7% received care in teaching hospitals. Adults presented dysphagia and food impaction more frequently; vomiting and weight loss predominated in children (p0.01). A mean diagnostic delay of 54.7 and 28.04 months was documented for adults and children, respectively. Normal endoscopic exams were reported in 27.6% and directly related to the experience in managing the disease (p0.05). Paediatric patients, non-teaching hospitals and greater experience in managing eosinophilic oesophagitis were associated with increased frequency in eosinophil count reports and with taking gastric and duodenal biopsies (p0.001). Initial therapy consisted of topical steroids (61.7% of patients), proton pump inhibitors (52.4%), dietary modifications (51.26%) and endoscopic dilation (7.2%). Referrals to allergy units occurred more frequently in teaching hospitals (p = 0.003) where food restrictions generally followed allergy test results (p0.001).Availability of facilities and the physician's experience constituted the most important factors in explaining differences in patient management.

Background and aims: Inflammatory bowel disease is a chronic disorder of the gastrointestinal tract. Tacrolimus is a calcineurin inhibitor used in the prophylaxis of rejection after a solid organ transplant. There is some evidence for its use in inflammatory bowel disease, although there is a lack of information about the patients who will benefit the most with this drug and the prognostic factors for a favorable response. Material and methods: We performed a multicentric retrospective study evaluating all the patients who have received tacrolimus in the last 10 years as a treatment for IBD in our area. Results: A total of 20 patients, 12 with Crohn’s disease and 8 with ulcerative colitis, were included in four hospitals. The two most common indications were steroid-dependency and fistulizing Crohn’s disease. The median time receiving tacrolimus was 11 months. In 12 patients the treatment was stopped. The main reasons for drug withdrawal were absence or loss of response. The median clinical follow-up was 35.5 months. Overall, a 25% achieved clinical remission and 40% were in partial response. Biologic-naive patients demonstrated a significantly better remission rate as compared with those that were not (80 vs. 7%). Patients who achieved remission were more likely to have a significant reduction in C-reactive protein values 1 month after starting the drug. Seven patients required surgery during the follow- up period. Conclusions: Patients naive to biologics showed a significantly better response to tacrolimus. A reduction in C-reactive protein one month after starting this drug was associated with clinical remission.