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.
Keywords:
Pharmacovigilance; Anticoagulants; Thrombin; Atrial fibrillation