In patients with nonvalvular atrial fibrillation (NVAF), adherence to direct-acting oral anticoagulant therapy (DOACs) is not significantly improved with the use of a pharmacist-led educational interventional program that involves motivational interviewing and evaluation with electronic monitoring. These findings were published in the journal Clinical Therapeutics.
Recognizing that nonadherence to DOACs can worsen prognosis in patients with NVAF, researchers conducted a prospective, randomized, controlled, interventional study at outpatient cardiology clinics located in general hospitals and pharmacies in Japan to assess the use of these 2 different approaches. The SMAAP-AF (Survey on Medication Adherence to Anticoagulant Drugs and Investigation of Improvement of Medication Adherence by an Educational Program in NVAF) study was conducted in 2 periods, Stage 1 (a 12-week observational period) and Stage 2 (a 12-week, single-blind, randomized, parallel-group intervention period).
In Stage 1, participants were provided with standard medication counseling by a pharmacist at the time of drug dispensation. An electronic monitoring device was provided in advance by the pharmacy or pharmacy department of the surveyed facility. In Stage 2, individuals allocated to the educational interventional program group participated in the motivational interviewing program, whereas those assigned to the standard medication counseling group continued to receive standard medication counseling from pharmacists.
Patients with NVAF who were receiving treatment with the once-daily DOAC edoxaban or the twice-daily DOAC apixaban were randomly assigned to 1 of 2 groups: an educational interventional program that involved motivational interviews regarding adherence to DOACs or standard medication counseling.
The primary study endpoint was change in the medication adherence rate, which was calculated as the number of days that the participants appropriately took the drug, as evaluated by an electronic monitoring device, divided by the total number of days that the drug was prescribed, from a 12-week observation period to a 12-week intervention period. Secondary endpoints included tolerability outcomes, such as major bleeding, stroke/systemic embolism, other serious adverse events (AEs), and AEs associated with discontinuation of the study intervention. The effect of the educational interventional program on the primary endpoint was analyzed in subgroups that were stratified according to gender and type of DOAC treatment received.
A total of 268 patients completed the observation period and were randomly assigned to receive either the educational program (n=134) or standard medication counseling (n=134). Among these participants, 77% had an indication for treatment with a DOAC as primary prevention.
Results of the study showed that those in both the educational interventional program and the standard medication counseling groups exhibited high rates of adherence in the observational period (92.9% vs 94.5%, respectively). Adherence rates were increased from Stage 1 to Stage 2 in both groups, but the difference between the 2 groups was not significant.
Although multiple regression analyses demonstrated no significant differences in medication adherence between the 2 groups, adherence to apixaban was significantly improved among men (change, from 94.5% to 99.8%; P =.012) but not among women (change, from 89.4% to 91.3%) in the educational interventional program. Overall, 2 patients died of causes unrelated to the treatment. No major bleeding events or cases of stroke/systemic embolism were reported.
A major limitation of the study is the fact that the selection of DOACs is not randomized. Selection bias may result partially from physician and patient preferences, concurrent medications, and associated comorbidities. Further, the number of medication counseling sessions in each participant is not standardized. As the study is a short-term assessment conducted in a small number of individuals, the impact of adherence on the clinical outcome cannot be evaluated.
“…adherence to DOACs, as assessed with electronic monitoring, was not significantly improved with a pharmacist-led educational interventional program involving motivational interviewing compared to standard medication counseling,” the study authors wrote.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Shiga T, Kimura T, Fukushima N, et al. Effects of a pharmacist-led educational interventional program on electronic monitoring-assessed adherence to direct oral anticoagulants: a randomized, controlled trial in patients with nonvalvular atrial fibrillation. Clin Ther. Published online October 13, 2022. doi:10.1016/j.clinthera.2022.09.011