RESUMO
Background: The purpose of inflammatory bowel disease (IBD) treatment is to achieve resolution of symptoms and remission of disease with a minimum of adverse events (AE). Aim: To report AE of different prescriptions used for the treatment of IBD. Material and Methods: Analysis of a registry of patients with IBD held at a private clinic from 1976 to 2013. All used medications, the occurrence and severity of AE were recorded. Results: The records of 346 patients aged 16 to 86 years, 74% with ulcerative colitis, were analyzed. The most commonly type of medications prescribed were 5-aminosalicylates (5-ASAs) in 329 patients (92%), followed by adrenal steroids in 218 (61%). Forty nine AE were recorded in the same number of patents (14%). These were more common in patients with Crohn disease (n = 19, 21%). An univariate analysis, demonstrated that extra-intestinal manifestations, hospitalizations secondary to IBD crisis, requirement of surgery and treatment with steroids, immunosuppressants or biologic agents were significantly associated with the presence of AE. AEs were more common with immunosuppressants, followed by 5-ASAs and steroids. Discontinuation of therapy was required in 79, 100 and 43% of patients taking these medications, respectively. Twenty percent of AEs were severe. Leukopenia and pancytopenia along with alopecia were the most common AEs attributable to azathioprine. Conclusions: The occurrence of AEs in patients with IBD is uncommon. Even inmunosuppressants or biologic agents have a low rate of AE and most of them mild.
Assuntos
Humanos , Pesquisa Biomédica/organização & administração , Dermatologia/organização & administração , Estudos Multicêntricos como Assunto , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Apoio à Pesquisa como Assunto/organização & administração , Antibacterianos/administração & dosagem , Pesquisa Biomédica/economia , Celulite (Flegmão)/prevenção & controle , Comportamento Cooperativo , Dermatologia/economia , Eczema/prevenção & controle , Reino Unido , Relações Interinstitucionais , Perna (Membro) , Estudos Multicêntricos como Assunto/economia , Objetivos Organizacionais , Avaliação de Programas e Projetos de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Pesquisadores/economia , Pesquisadores/organização & administração , Abrandamento da ÁguaRESUMO
Conducting economic evaluation alongside clinical trials is an efficient way of getting valid and reliable information with minimum assumptions made during data collection. However, design of a randomised control trial (RCT) takes away several of the real world situations, the variations in resource utilisation, their cost due to close supervision and monitoring of the study subjects. Suitable sensitivity analysis has to be done to make the economic data obtained more pragmatic and hence utilised by the policy makers.