RESUMO
BACKGROUND AND AIMS: Data on the outcomes after switching from adalimumab (ADA) originator to ADA biosimilar are limited. The aim was to compare the treatment persistence, clinical efficacy, and safety outcomes in inflammatory bowel disease patients who maintained ADA originator vs. those who switched to ADA biosimilar. METHODS: Patients receiving ADA originator who were in clinical remission at standard dose of ADA originator were included. Patients who maintained ADA originator formed the non-switch cohort (NSC), and those who switched to different ADA biosimilars constituted the switch cohort (SC). Clinical remission was defined as a Harvey-Bradshaw index ≤4 in Crohn's disease and a partial Mayo score ≤2 in ulcerative colitis. To control possible confounding effects on treatment discontinuation, an inverse probability treatment weighted proportional hazard Cox regression was performed. RESULTS: Five hundred and twenty-four patients were included: 211 in the SC and 313 in the NSC. The median follow-up was 13 months in the SC and 24 months in the NSC (p < 0.001). The incidence rate of ADA discontinuation was 8% and 7% per patient-year in the SC and in the NSC, respectively (p > 0.05). In the multivariate analysis, switching from ADA originator to ADA biosimilar was not associated with therapy discontinuation. The incidence rate of relapse was 8% per patient-year in the SC and 6% per patient-year in the NSC (p > 0.05). Six percent of the patients had adverse events in the SC vs. 5% in the NSC (p > 0.05). CONCLUSION: Switching to ADA biosimilar did not impair patients' outcomes in comparison with maintaining on the originator.
Assuntos
Medicamentos Biossimilares , Doenças Inflamatórias Intestinais , Humanos , Infliximab/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Adalimumab/uso terapêutico , Fármacos Gastrointestinais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Substituição de Medicamentos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Resultado do TratamentoRESUMO
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 (<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. CONCLUSIONS: 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.
Assuntos
Colectomia/estatística & dados numéricos , Colite Ulcerativa/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Fatores Biológicos/uso terapêutico , Criança , Colite/diagnóstico , Colite/tratamento farmacológico , Colite/cirurgia , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/tratamento farmacológico , Emergências , Feminino , Humanos , Ileostomia/estatística & dados numéricos , Fatores Imunológicos/uso terapêutico , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Esteroides/uso terapêutico , Fatores de Tempo , Adulto JovemRESUMO
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.
Assuntos
Endoscopia por Cápsula/estatística & dados numéricos , Tomada de Decisão Clínica , Doença de Crohn/terapia , Gerenciamento Clínico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Índice de Gravidade de Doença , Adulto JovemRESUMO
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.
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Colite Ulcerativa , Doenças Inflamatórias Intestinais , Adalimumab/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/uso terapêutico , Recidiva , Indução de Remissão , Estudos Retrospectivos , Resultado do Tratamento , Inibidores do Fator de Necrose Tumoral , Fator de Necrose Tumoral alfaRESUMO
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 <10 ng/mL; odds ratio 0.23, 95% CI 0.05-0.87) and the concomitant use of thiopurines (odds ratio 0.18, 95% CI 0.04-0.81) were associated with lower clinical disease activity at 3 months. Of 62 patients with perianal disease, complete closure was observed in 8% (n = 5) of patients with perianal fistulas, with 34% (n = 21) showing partial response. Treatment was maintained for a median of 6 months (IQR, 2-16). After a median clinical follow-up of 24 months (IQR, 15-57), the rate of treatment-related adverse events was 34%, correlating with blood drug concentrations (P = 0.021). Finally, 120 patients (84%) discontinued tacrolimus, usually due to absence or loss of response. Three patients (2%) were subsequently diagnosed with cancer. The overall rate of surgery was 39%, with a 33% colectomy rate in UC. CONCLUSIONS: Tacrolimus shows a clinical benefit in both CD and UC after 3 months of treatment, but its long-term effectiveness and frequent adverse events remain relevant issues in clinical practice.
Assuntos
Doenças Inflamatórias Intestinais/tratamento farmacológico , Tacrolimo/uso terapêutico , Adulto , Colectomia/estatística & dados numéricos , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/epidemiologia , Colite Ulcerativa/cirurgia , Doença de Crohn/tratamento farmacológico , Doença de Crohn/epidemiologia , Doença de Crohn/cirurgia , Feminino , Humanos , Doenças Inflamatórias Intestinais/epidemiologia , Doenças Inflamatórias Intestinais/cirurgia , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Espanha/epidemiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
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 50 mg every 4 weeks (q4wk) was optimized before week 14 to 100 mg 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 80 kg were assigned to a golimumab maintenance dose of 50 mg q4wk. Twenty-four patients (15.9% [12.5% overall]), in whom scheduled doses of 50 mg q4wk were optimized to 100 mg 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 12 months (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.
Assuntos
Anticorpos Monoclonais/administração & dosagem , Colite Ulcerativa/tratamento farmacológico , Corticosteroides/uso terapêutico , Adulto , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Índice de Gravidade de Doença , Resultado do Tratamento , Adulto JovemRESUMO
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.
Assuntos
Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/complicações , Tuberculose Latente/complicações , Tuberculose Latente/diagnóstico , Soroconversão , Testes Cutâneos , Adalimumab/uso terapêutico , Corticosteroides/uso terapêutico , Adulto , Anticorpos Monoclonais/uso terapêutico , Antituberculosos/uso terapêutico , Feminino , Humanos , Imunossupressores/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/uso terapêutico , Tuberculose Latente/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fumar , Fator de Necrose Tumoral alfa/antagonistas & inibidoresRESUMO
BACKGROUND: Adalimumab is the second tumour necrosis factor antagonist (anti-TNF) adopted for the treatment of ulcerative colitis. Clinical data from naïve patients are scarce. AIM: Examine the response to adalimumab in TNF-antagonist-naïve 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, pâ¯<â¯0.006). CONCLUSIONS: Adalimumab treatment of ulcerative colitis is effective; the results are better in clinical practice and in patients naïve to anti-TNF.
Assuntos
Adalimumab/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/efeitos adversos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Prospectivos , Análise de Regressão , Indução de Remissão , Índice de Gravidade de Doença , Espanha , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
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. Biologics-naïve 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 naïve 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.
Assuntos
Produtos Biológicos/efeitos adversos , Proteína C-Reativa/análise , Imunossupressores/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Tacrolimo/uso terapêutico , Adolescente , Adulto , Criança , Doença de Crohn/complicações , Doença de Crohn/tratamento farmacológico , Feminino , Humanos , Masculino , Estudos Retrospectivos , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: The "Adult Eosinophilic Esophagitis Quality of Life (EoE-QoL-A) Questionnaire" was developed in English as a valid, reliable, and disease-specific health-related QoL measure.This research aims to adapt and validate this questionnaire for Spanish-speaking patients. PATIENTS AND METHODS: A multicenter, observational, prospective study was conducted at 8 Spanish hospitals. The cultural adaptation of the original EoE-QoL-A questionnaire was undertaken through a standardized 3-phase procedure: 1. Translation; 2. Retrotranslation; and 3. Pilot study. Patients completed the Hospital Anxiety and Depression Scale (HADS), the Short Form (SF)-12, the Brief Illness Perception Questionnaire (BIPQ), and the adapted EoE-QoL-A, with a retest 3 months later.Statistical analysis included construct validity, internal consistency, criterion validity, and reproducibility. RESULTS: One hundred and seventy adult EoE patients (73.5 % male; aged 33.5 ± 11.4-y) were included in the study.With regard to internal validity, all Cronbach alpha values were > 0.75. A significant correlation between items assessed in the SF-12, BIPQ and EoE-QoL-A questionnaires (p < 0.001) was observed. Correlations with the HADS were stronger for anxiety than for depression levels. Anxiety related to disease diagnosis and choking were the most affected dimensions; less affected were the dimensions related to eating, social, and emotional development. Intraclass correlation coefficients between the test and retest assessments were acceptable for all questionnaires, with the highest values (0.73-0.84) calculated for the EoE-QoL-A Spanish version. CONCLUSION: The Spanish version of the EoE-QoL-A is a reliable, valid, and responsive questionnaire. Diagnosis and choking anxiety were the most affected dimensions in the health-related QoL in adult EoE patients.
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Esofagite Eosinofílica/complicações , Qualidade de Vida , Inquéritos e Questionários , Adulto , Feminino , Humanos , Idioma , Masculino , Estudos Prospectivos , Reprodutibilidade dos Testes , Traduções , Adulto JovemRESUMO
UNLABELLED: 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. OBJECTIVES: 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. PATIENTS AND METHODS: 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. RESULTS: 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 INR <4). CONCLUSIONS: 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.
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Acenocumarol/efeitos adversos , Pólipos Adenomatosos/complicações , Anticoagulantes/efeitos adversos , Úlcera Duodenal/complicações , Hemorragia Gastrointestinal/etiologia , Neoplasias Gastrointestinais/complicações , Úlcera Gástrica/complicações , Acenocumarol/uso terapêutico , Doença Aguda , Pólipos Adenomatosos/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Úlcera Duodenal/epidemiologia , Endoscopia Gastrointestinal , Varizes Esofágicas e Gástricas/complicações , Varizes Esofágicas e Gástricas/epidemiologia , Esofagite/complicações , Esofagite/epidemiologia , Feminino , Gastroenterite/complicações , Gastroenterite/epidemiologia , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Neoplasias Gastrointestinais/epidemiologia , Hemorroidas/complicações , Hemorroidas/epidemiologia , Humanos , Incidência , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Úlcera Gástrica/epidemiologiaRESUMO
BACKGROUND: Eosinophilic oesophagitis has emerged as a common cause of oesophageal symptoms. AIMS: To document practice variation in care provided to eosinophilic oesophagitis patients in Spain and to assess adherence to available guidelines. METHODS: A prospective survey-based registry including data from all patients receiving care from gastroenterologists and allergists throughout Spain was developed. RESULTS: 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 (p < 0.01). 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 (p < 0.05). 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 (p < 0.001). 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 (p < 0.001). CONCLUSIONS: Availability of facilities and the physician's experience constituted the most important factors in explaining differences in patient management.
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Esofagite Eosinofílica/diagnóstico , Fidelidade a Diretrizes/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Sistema de Registros , Adolescente , Corticosteroides/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Alergia e Imunologia/normas , Biópsia , Criança , Pré-Escolar , Dietoterapia , Dilatação , Esofagite Eosinofílica/terapia , Monitoramento do pH Esofágico , Esofagoscopia , Feminino , Gastroenterologia/normas , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Inibidores da Bomba de Prótons/uso terapêutico , Espanha , Adulto JovemRESUMO
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.