Please use this identifier to cite or link to this item: https://app.uff.br/riuff/handle/1/8025
Title: Farmacovigilância ativa e estudo do dabigatrana, um novo anticoagulante oral, em hospital público brasileiro especializado em cardiologia
Authors: Martins, Luise de Barros
metadata.dc.contributor.advisor: Scaramello, Christianne Brêtas Vieira
metadata.dc.contributor.members: Scaramello, Christianne Brêtas Vieira
Marins, Rita de Cássia Elias Estrela
Elias, Sabrina Calil
Brito, Fernanda Carla Ferreira de
Martins, Wolney de Andrade
Issue Date: 2016
Abstract: Introducao: Durante sua fase de comercializacao, efeitos ineditos de novos medicamentos podem ser descobertos. O dabigratana e um potente inibidor direto e reversivel de trombina, aprovado pela Agencia Nacional de Vigilancia Sanitaria em 2008. Objetivos: Avaliar seguranca, efetividade, perfil de eventos adversos e adesao terapeutica ao dabigatrana (110mg e 150mg) prescrito para pacientes com fibrilacao atrial nao valvar do Instituto Nacional de Cardiologia. Metodos: Pacientes em uso de dabigatrana 110mg e 150mg foram submetidos a entrevistas ao longo do primeiro ano de tratamento, tendo sido avaliados a prescricao em funcao da dose, da idade, do genero e dos fatores de risco, bem como a prevalencia de eventos adversos e o perfil dos pacientes envolvidos. Resultados: Entre o inicio e o final do estudo houve reducao do numero de pacientes em uso do anticoagulante (10% na dose de 110mg e 30% na dose de 150mg), sem variacao nas proporcoes dos individuos quanto ao genero (homens ƒ° 65%), faixa etaria (idade inferior a 75 anos ƒ° 80%), historico de anticoagulacao previa (ƒ° 85%) e escores de risco para eventos tromboembolicos (CHA2DS2-VASc . 2 ƒ° 80%) e hemorragicos (HASBLED < 3 ƒ° 50% dose 110mg e ƒ° 85% dose 150mg). O evento adverso mais comum foi a dispepsia (. 10%), independente do genero, porem com menos frequencia na faixa etaria superior a 75 anos (ƒ° 20% dos casos). A dispepsia relacionada ao dabigatrana foi associada principalmente a sua combinacao com betabloqueadores adrenergicos (ƒ° 70%), porem minoritariamente com hipoglicemiantes orais (ƒ° 20%), antiplaquetarios (ƒ° 10%), inibidores da bomba de protons (ƒ° 30%) e antagonistas de receptores H2 (ƒ° 3%). A adesao terapeutica foi de ƒ° 60%, independentemente dos eventos adversos relatados. Nao foram observados casos de evento tromboembolico tampouco sangramento maior. Conclusao: O dabigatrana mostrou-se seguro e efetivo nas condicoes avaliadas
metadata.dc.description.abstractother: Introduction: During its commercialization phase, unpublished effects of new medicaments can be discovered. Dabigatran is a potent inhibitor and reversible direct thrombin, approved by Brazilian National Health Surveillance Agency in 2008. Objectives: To assess safety, effectiveness adverse event profile and adherence to dabigatran (110mg and 150mg) prescribed for patients with non-valvular atrial fibrillation of the National Institute of Cardiology. Methods: Patients taking dabigatran 110mg and 150mg were subjected to interviews during the first year of treatment, evaluating the prescription depending on the dose, age, gender, risk factors, the prevalence of adverse events and the profile of the patients involved. Results: Between the beginning and end of the study there was a reduction in the number of subjects in anticoagulant use (10% at the dose of 110mg and 30% at the dose of 150mg), no change in the proportions of individuals with regard to gender (men ƒ° 65%), age group (age < 75 years ƒ° 80%), anticoagulation prior history (ƒ° 85%) and risk scores for thromboembolic events (CHA2DS2-VASc . 2 ƒ° 80%) and bleeding (HASBLED < 3 ƒ° 50% dose 110mg and ƒ° 85% dose 150mg). The most common adverse events were dyspepsia (. 10%), regardless of gender, but less frequently in the upper age to 75 years (ƒ° 20% of cases). Dyspepsia related to dabigatran was mainly associated with its combination with adrenergic beta-blockers (ƒ° 70%), but a minority with oral hypoglycemic (ƒ° 20%), antiplatelet agents (ƒ° 10%), proton pump inhibitors (ƒ° 30%) and antagonists H2 (ƒ° 3%). Therapeutic adherence was ƒ° 60% regardless of the reported adverse events. There were no cases of thromboembolic event and major bleeding. Conclusions: Dabigatran was shown to be safe and effective in the evaluated conditions
URI: https://app.uff.br/riuff/handle/1/8025
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