Study of Dabigatran Use in a Brazilian Public Hospital Specialized in Cardiology

Abstract Background: During its commercialization phase, unprecedented effects of new medicaments can be discovered. Dabigatran is an anticoagulant approved by Brazilian National Health Surveillance Agency in 2008. Objectives: To assess safety, effectiveness adverse event profile and adherence to dabigatran (110 mg and 150 mg) prescribed for patients with non-valvular atrial fibrillation. Methods: Patients taking dabigatran were subjected to interviews during the first year of treatment, evaluating the prescription depending on the dose, age, gender and risk factors as well as the prevalence of adverse events and the profile of the patients involved. Results: Between the beginning and the end of the study there was a reduction in the number of subjects using this anticoagulant (10% for the dose of 110 mg and 30% for the dose of 150 mg), without changes in the proportions of individuals regarding to gender (men ≅65%), age (age <75 anos ≅80%), anticoagulation previous history (≅85%) and risk scores for thromboembolic (CHA2DS2≥VASc = 2 ≅80%) and bleeding (HASBLED <3 ≅50% dose 110 mg and ≅85% dose 150 mg) events. The most common adverse event was dyspepsia (≥10%), regardless of gender, but less frequently in patients over 75 years of age (≅20% of cases). Dyspepsia related to dabigatran was mainly associated to its combination with beta-blockers (≅70%), but minoritarily with oral hypoglycemic (≅20%), antiplatelet agents (≅10%), proton pump inhibitors (≅30%) and antagonists H2 (≅3%). Therapeutic adherence was ≅60% regardless of the described adverse events. There were no cases of thromboembolic event and major bleeding. Conclusions: Dabigatran has shown to be safe and effective in the evaluated conditions.

背景：在新药商业化阶段，可能会发现此前未被报道的全新临床效应。达比加群（dabigatran）是2008年获巴西国家卫生监督局批准的抗凝药物。研究目的：评估用于非瓣膜性心房颤动患者的达比加群（110mg与150mg两种剂量）的安全性、有效性、不良事件谱及其用药依从性。研究方法：对服用达比加群的患者在治疗首年开展访谈，评估不同剂量、年龄、性别、风险因素下的处方情况，同时统计不良事件患病率与受试患者的临床特征。研究结果：研究全程中，使用该抗凝药物的受试者数量有所减少（110mg剂量组减少10%，150mg剂量组减少30%）；受试者的性别比例（男性约占65%）、年龄分布（75岁以下者约占80%）、既往抗凝治疗史（约占85%）、血栓栓塞风险评分（CHA₂DS₂-VASc≥2分者约占80%）与出血风险评分（HAS-BLED评分<3分者：110mg剂量组约占50%，150mg剂量组约占85%）的构成比均无显著变化。无论性别，最常见的不良事件为消化不良（发生率≥10%），但75岁以上患者的该不良事件发生率更低，该人群中消化不良病例约占不良事件总病例的20%。达比加群相关消化不良主要与联合使用β受体阻滞剂有关（约占70%），其次为口服降糖药（约占20%）、抗血小板药物（约占10%）、质子泵抑制剂（约占30%）与H2受体拮抗剂（约占3%）。无论是否出现不良事件，患者的治疗依从性均约为60%。本研究未出现血栓栓塞事件与大出血病例。研究结论：在所评估的临床场景中，达比加群展现出良好的安全性与有效性。