Dabigatran is a new oral anticoagulant that has been approved by the Food and Drug Administration for the treatment of patients with NVAF (non-valvular atrial fibrillation). The paper is to retrospectively evaluate ...Dabigatran is a new oral anticoagulant that has been approved by the Food and Drug Administration for the treatment of patients with NVAF (non-valvular atrial fibrillation). The paper is to retrospectively evaluate the safety of dabigatran in patients with NVAF. We performed a retrospective cohort analysis of our registries for patients using dabigatran. The clinical safety endpoints included major bleeding, stroke, death, and any other reported or documented adverse events. All other major and minor events were recorded and documented during the treatment period. Of the 80 patients included in the analysis, 26% of those receiving a dose of 150 mg experienced adverse events, including two cases of minor bleeding and one case of stroke, whereas 8% of those receiving a dose of 110 mg experienced adverse events, including one case of major gastric bleeding and one case of death. The most common adverse event was gastric distress. Moreover, we noted cases of minor urethral and optic nerve bleeding, major gastric bleeding, stroke, and death. Treatment with dabigatran is primarily successful in low-risk profile patients, without any major or minor events, whereas high-risk patients may require further evaluation before dabigatran treatment initiation and careful monitoring during the treatment period.展开更多
文摘Dabigatran is a new oral anticoagulant that has been approved by the Food and Drug Administration for the treatment of patients with NVAF (non-valvular atrial fibrillation). The paper is to retrospectively evaluate the safety of dabigatran in patients with NVAF. We performed a retrospective cohort analysis of our registries for patients using dabigatran. The clinical safety endpoints included major bleeding, stroke, death, and any other reported or documented adverse events. All other major and minor events were recorded and documented during the treatment period. Of the 80 patients included in the analysis, 26% of those receiving a dose of 150 mg experienced adverse events, including two cases of minor bleeding and one case of stroke, whereas 8% of those receiving a dose of 110 mg experienced adverse events, including one case of major gastric bleeding and one case of death. The most common adverse event was gastric distress. Moreover, we noted cases of minor urethral and optic nerve bleeding, major gastric bleeding, stroke, and death. Treatment with dabigatran is primarily successful in low-risk profile patients, without any major or minor events, whereas high-risk patients may require further evaluation before dabigatran treatment initiation and careful monitoring during the treatment period.