Strategies for improving dabigatran adherence for stroke prevention in patients with non-valvular atrial fibrillation: education and drug intake reminders (FACILITA study)

Abstract

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.

Keywords:

• Therapeutic compliance
• Dabigatran
• Oral anticoagulants
• Non-valvular atrial fibrillation
• Preventing stroke

Transparency

Declaration of funding

This study has been sponsored through a research grant from Boehringer Ingelheim Spain S.A.

Declaration of financial/other interests

The authors have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work. A CMRO peer reviewer also declares that they received consulting fees from Boehringer Ingelheim. All other peer reviewers on this manuscript have no other relevant financial relationships to disclose.

Previous presentations

This study will be presented as an oral communication at the XIX National Meeting of The Spanish Society of Hypertension to be held in Zaragoza, Spain (March 2018).

Acknowledgments

The authors would like to thank the investigators of the FACILITA study for their work, as well as the members of the Compliance and Inertia Working Group of the Spanish Society of Hypertension.