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

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.

Quality of life with rivaroxaban in patients with non-valvular atrial fibrilation by therapeutic compliance.

OBJECTIVE: To assess the quality of life (QOL) with rivaroxaban in patients with non-valvular atrial fibrilation (NVAF) related to therapeutic compliance. METHODS: Prospective, longitudinal, multicenter study was 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 electronic monitoring systems. QOL was measured by a specific questionnaire. We calculated the percentage of compliance means, the percentage of daily compliers and the score of QOL. RESULTS: Three hundred and seventy patients finished the study (mean age 75.19 SD: 7.5 years). Daily compliance was 83.5% (CI 78.53-88.57%) (n = 309) and 80% (CI 74.65-85.35%) at 6 and 12 months, respectively. Average QOL rating was 112.85 (SD 29.31) in non-compliant and 111.80 (SD 29.31) in the compliant group (p = Not significant), and after 12 months of 124.67 (SD 30.78) and 83.47 (SD 26.44), respectively (p < 0.0001), with a decrease in the score compliers (p < 0.01) and an increase in non-compliant group (p < 0.05). A higher number of drugs consumed, as well as the number of diseases/conditions suffered, the older age of the patients and having been previously treated with VKA were associated with a higher overall score (worse QOL). CONCLUSIONS: QOL in NVAF patients treated with rivaroxaban improved significantly over the study group at the expense of compliers. A worse QOL was associated with pluripathology, polymedication, older patients and previous treatment with VKA.

Therapeutic compliance with rivaroxaban in preventing stroke in patients with non-valvular atrial fibrillation: CUMRIVAFA study.

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.

Eficacia de un programa de automedida domiciliaria de la presión arterial como estrategia para disminuir la inercia terapéutica / Prevention of therapeutic inertia in the treatment of arterial hypertension by using a program of home blood pressure monitoring

Objetivo: Evaluar si un programa de automedida domiciliaria de presión arterial (AMPA) es eficaz para obtener una menor inercia terapéutica (IT) en el tratamiento de la HTA. Diseño: Estudio clínico controlado, aleatorizado y multicéntrico. Emplazamiento: 35 centros de salud de España. Participantes: Se incluyeron 232 hipertensos. Intervención: Se formaron 2 grupos con 116 individuos: 1, grupo de control (GC): recibieron la intervención habitual; 2, grupo de intervención: se inscribieron en un programa de AMPA. Mediciones principales: La IT se midió mediante el cociente: (Número de pacientes sin modificación del tratamiento farmacológico en cada visita / Número de pacientes con cifras medias de PA ≥ 140 mmHg y/o ≥ 90 mmHg en población general o ≥ 130 y/o 80 mmHg en diabéticos) y multiplicado por 100. Se calculó la IT por visitas, las PA medias y grado de control de la HTA. Resultados: Concluyeron 209 individuos (edad media 69,28±11,6 años) (p=NS por grupos) (GI 107 individuos y GC 102).La IT fue 35,64% de las visitas de la muestra (IC=29,85-41,43%) y en el 71,63% (IC=63,9-79,36%) en hipertensos no controlados. La IT fue del 22,42% (IC=24,2-37%) en el GI y 50% (IC=37,75-62,25) en el GC (p < 0,05) en visita 2, y del 25,23% (IC=14,84-35,62) y 46,07% (IC=33,85-58,29) en visita final para GI y GC respectivamente (p<0,05). Conclusiones: La IT ha sido muy relevante. El programa de AMPA es eficaz para obtener una menor IT(AU)

Objective: To evaluate the efficacy of a program of home blood pressure monitoring (HBPM) on therapeutic Inertia (TI) in mild-to-moderate hypertension (AHT). Design: Controlled, randomised clinical trial. Setting: Forty six clinics in 35 primary care centres. Spain. Participants: A total of 232 patients with uncontrolled hypertension were included. Intervention: Two groups with 116 patients were formed: 1) Control group (CG): standard health intervention; 2) Intervention group (IG): patients who were included in the HBPM program. Main measurements: TI was calculated by the ratio: Number of patients whose pharmacological treatment was not changed in each visit/Number of patients with an average BP 140mmHg and/or 90mmHg in the general population or 130 and/or 90 mmHg in diabetics. The mean BPs and the percentage of controlled patients were calculated. The mean number of people that required an intervention in order to avoid TI was calculated (NI). Results: A total of 209 patients completed the study, with TI in 35.64% (95% CI=29.85%-41.43%) of the sample, and in 71.63% (95% CI=63.9-79.36%) of the uncontrolled hypertensive patients. The TI was 22.42% (95% CI=24.2-37%) in the IG and 50% (95% CI=37.75-62.25) in the CG (p<.05) in visit 2, and 25.23% (95% CI=14.84-35.62) and 46.07% (95% CI=33.85-58.29) in the final visit for IG and CG, respectively (P<.05). The NI was 4.3. Conclusions: TI was very significant among the uncontrolled hypertensive patients. The studied interventions are effective for improving TI(AU)

[Prevention of therapeutic inertia in the treatment of arterial hypertension by using a program of home blood pressure monitoring]. / Eficacia de un programa de automedida domiciliaria de la presión arterial como estrategia para disminuir la inercia terapéutica.

OBJECTIVE: To evaluate the efficacy of a program of home blood pressure monitoring (HBPM) on therapeutic Inertia (TI) in mild-to-moderate hypertension (AHT). DESIGN: Controlled, randomised clinical trial. SETTING: Forty six clinics in 35 primary care centres. Spain. PARTICIPANTS: A total of 232 patients with uncontrolled hypertension were included. INTERVENTION: Two groups with 116 patients were formed: 1) Control group (CG): standard health intervention; 2) Intervention group (IG): patients who were included in the HBPM program. MAIN MEASUREMENTS: TI was calculated by the ratio: Number of patients whose pharmacological treatment was not changed in each visit/Number of patients with an average BP 140mmHg and/or 90mmHg in the general population or 130 and/or 90 mmHg in diabetics. The mean BPs and the percentage of controlled patients were calculated. The mean number of people that required an intervention in order to avoid TI was calculated (NI). RESULTS: A total of 209 patients completed the study, with TI in 35.64% (95% CI=29.85%-41.43%) of the sample, and in 71.63% (95% CI=63.9-79.36%) of the uncontrolled hypertensive patients. The TI was 22.42% (95% CI=24.2-37%) in the IG and 50% (95% CI=37.75-62.25) in the CG (p<.05) in visit 2, and 25.23% (95% CI=14.84-35.62) and 46.07% (95% CI=33.85-58.29) in the final visit for IG and CG, respectively (P<.05). The NI was 4.3. CONCLUSIONS: TI was very significant among the uncontrolled hypertensive patients. The studied interventions are effective for improving TI.