RESUMEN
Objective To assess the efficacy of a mixed intervention, educational, and reminder calendar of the intake, as a strategy to improve therapeutic adherence with dabigatran in patients with non-valvular atrial fibrillation (NVAF). Methods This was a prospective, longitudinal, multi-center study, carried out in 110 specialized healthcare centers in Spain. Seven hundred and twenty-six patients treated with dabigatran prescribed for stroke prevention were included. A cluster randomization was performed based on two groups: (1) Control Group (CG) as usual clinical practice, and (2) Intervention Group (IG) with a mixed strategy: (a) Healthcare education, and (b) Use of a reminder calendar for taking the anticoagulant medication. Three visits took place: baseline and follow-up at 6 and 12 months. Compliance was measured by using electronic monitors (MEMS). Average adherence percentage (%; Average AP) and daily compliance (%; Daily AP) was calculated. A patient was considered adherent when AP was 80-100%. Results Six hundred and twenty-five patients completed the study (315 in the IG and 310 in the CG). Daily AP was 91.97% at 6 months and 91.05% after 12 months in the IG and 82.26% and 82.63% in the CG. Average adherence was 90.79% and 89.20% in the IG and 64.51% and 63.22% in the CG at 6 and 12 months, respectively. Significant differences were observed in the Daily AP and Average AP, with higher percentages in the IG. In the non-adherents group, the number of concomitant drugs, baseline, and 6 months SBP values, 6 and 12 months DBP values, and weight, total cholesterol, and LDL cholesterol were significantly higher. The number needed to treat (NNT) was 3.84 patients to prevent one non-adherence. Conclusions A mixed intervention, consisting of patient education and a simple calendar reminder of drug intake, is an effective strategy to improve dabigatran therapeutic adherence in patients with NVAF. The percentage of adherence with dabigatran was high.
Asunto(s)
Antitrombinas/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Dabigatrán/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Educación del Paciente como Asunto/métodos , Accidente Cerebrovascular , Humanos , Estudios Longitudinales , Estudios Prospectivos , Sistemas Recordatorios , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/prevención & controlRESUMEN
OBJECTIVE: To assess compliance with treatment with rivaroxaban in patients with non-valvular atrial fibrillation. METHODS: Prospective, longitudinal, multicenter study, developed in 160 Spanish primary or specialized care centers. We included 412 patients treated with rivaroxaban, prescribed for stroke prevention. Three visits were conducted: baseline, 6 and 12 months. Compliance was measured by using electronic monitors (MEMSs) that use a digital record in the form of a microchip in the lid of the drug container that automatically controls its opening and registers the time and date of the opening. We calculated the average compliance percentage (CP), global and daily compliance. We considered compliance to be when CP was 80-100%. RESULTS: Three hundred and seventy patients ended the study (mean age 75.19, SD: 7.5 years). Global compliance was 84.1% (CI = 79.21-88.99%) and 80.3% (CI = 74.98-85.62%) after 6 and 12 months respectively. Daily compliance was 83.5% (CI = 78.53-88.57%) and 80% (CI = 74.65-85.35%) at 6 and 12 months. Significant differences in the CP between 6 and 12 months were observed. Global CP was 90.77% after 6 months and 89.65% at the end of the study. Daily CP was 90.14% and 87.66% at 6 and 12 months. There were significant CP differences between 6 and 12 months. Non-compliance was associated with a higher number of concomitant diseases, number of drugs taken and weight. CONCLUSIONS: The percentage of compliance with rivaroxaban was high. A profile of variables that need to be modified in current medical practice, associated with non-compliance, was detected.