Situación del tratamiento anticoagulante oral en pacientes con fibrilación auricular no valvular en España. Estudio REACT-AF / Status of oral anticoagulant treatment in patients with nonvalvular atrial fibrillation in Spain. REACT-AF Study

Antecedentes y objetivos: La terapia anticoagulante oral resulta compleja dadas las necesidades de control y el riesgo hemorrágico que conlleva. Este estudio pretende determinar la práctica clínica habitual del tratamiento para la prevención del ictus en pacientes con fibrilación auricular no valvular (FANV) en España. Pacientes y método: El Real Evidence of Anti Coagulation Treatment in AF es una cohorte multicéntrica, europea, multinacional, observacional, de seguimiento retrospectivo, de pacientes con FANV. En este estudio se incluye a los pacientes reclutados en España con al menos una visita en el periodo de inclusión (mayo 2010/abril 2012). Se evaluaron: a) la persistencia del tratamiento con anticoagulantes orales (tiempo hasta discontinuación); b) la tasa de persistencia (porcentaje de pacientes en tratamiento) a los 6, 12 y 24 meses, y 5 años; c) la adherencia terapéutica (tasa de posesión de medicación); d) la concordancia entre el tratamiento seguido y el recomendado según la Sociedad Europea de Cardiología; y e) la incidencia de ictus y eventos hemorrágicos. Resultados: Los pacientes tratados con anticoagulantes orales (n=7.526) presentaron un tiempo hasta discontinuación del tratamiento de 1,99 años (mediana) y una tasa de persistencia a 5 años del 26% (discontinuación ≥3 meses). La adherencia (tasa de posesión de medicación media) fue 0,54±0,36. La incidencia de ictus fue 0,3/100 personas-año y la de eventos hemorrágicos, 2,4/100 personas-año. El 58% de los pacientes con FANV (n=12.514) seguía las recomendaciones de la Sociedad Europea de Cardiología. Conclusión: El 42% de los pacientes con FANV no seguía las recomendaciones de la Sociedad Europea de Cardiología. Se detectó una baja persistencia y adherencia al tratamiento con anticoagulantes orales (AU)

Background and objectives: Oral anticoagulant therapy is complex due to the need for control and the hemorrhagic risk the therapy entails. This study aims to determine the standard clinical practice in the treatment for preventing stroke in patients with nonvalvular atrial fibrillation (NVAF) in Spain. Patients and method: The Real Evidence of Anti Coagulation Treatment in AF is a European, multicenter, multinational, observational, retrospectively monitored cohort of patients with NVAF. This study included patients recruited in Spain with at least one visit during the period of inclusion (May 2010/April 2012). The study evaluated the following: a) persistence of oral anticoagulant treatment (time to discontinuation); b) persistence rate (% of patients in treatment) at 6, 12 and 24 months and at 5 years; c) therapeutic compliance (medication possession ratio); d) the correlation between the treatment followed and that recommended by the European Society of Cardiology; and the incidence of stroke and hemorrhagic events. Results: The patients treated with oral anticoagulants (n=7,526) had a median time to discontinuation of treatment of 1.99 years and a persistence rate at 5 years of 26% (discontinuation ≥3 months). The compliance (mean MPR) was 0.54±0.36. The incidence of stroke was 0.3/100 person-years, and the incidence of hemorrhagic events was 2.4/100 person-years. Fifty-eight percent of the patients with NVAF (n=12,514) followed the recommendations of the European Society of Cardiology. Conclusion: Forty-two percent of the patients with NVAF did not follow the recommendations of the European Society of Cardiology. We detected low persistence and treatment compliance rates for oral anticoagulants (AU)

Status of oral anticoagulant treatment in patients with nonvalvular atrial fibrillation in Spain. REACT-AF Study. / Situación del tratamiento anticoagulante oral en pacientes con fibrilación auricular no valvular en España. Estudio REACT-AF.

BACKGROUND AND OBJECTIVES: Oral anticoagulant therapy is complex due to the need for control and the hemorrhagic risk the therapy entails. This study aims to determine the standard clinical practice in the treatment for preventing stroke in patients with nonvalvular atrial fibrillation (NVAF) in Spain. PATIENTS AND METHOD: The Real Evidence of Anti Coagulation Treatment in AF is a European, multicenter, multinational, observational, retrospectively monitored cohort of patients with NVAF. This study included patients recruited in Spain with at least one visit during the period of inclusion (May 2010/April 2012). The study evaluated the following: a) persistence of oral anticoagulant treatment (time to discontinuation); b) persistence rate (% of patients in treatment) at 6, 12 and 24 months and at 5 years; c) therapeutic compliance (medication possession ratio); d) the correlation between the treatment followed and that recommended by the European Society of Cardiology; and the incidence of stroke and hemorrhagic events. RESULTS: The patients treated with oral anticoagulants (n=7,526) had a median time to discontinuation of treatment of 1.99 years and a persistence rate at 5 years of 26% (discontinuation ≥3 months). The compliance (mean MPR) was 0.54±0.36. The incidence of stroke was 0.3/100 person-years, and the incidence of hemorrhagic events was 2.4/100 person-years. Fifty-eight percent of the patients with NVAF (n=12,514) followed the recommendations of the European Society of Cardiology. CONCLUSION: Forty-two percent of the patients with NVAF did not follow the recommendations of the European Society of Cardiology. We detected low persistence and treatment compliance rates for oral anticoagulants.

Análisis coste-efectividad de apixaban frente a dabigatrán en la prevención de la tromboembolia venosa en pacientes intervenidos de artroplastia total de rodilla o de cadera / Cost-effectiveness analysis of apixaban compared to dabigatran in the prevention of venous thromboembolism in patients subjected to total knee or hip replacement

Objetivo. Análisis de coste-efectividad de apixaban frente a dabigatrán en la prevención de la tromboembolia venosa (TEV) en la artroplastia total de rodilla (ATR) o cadera (ATC). Métodos. Modelo con 2 periodos: posprevención de 90 días (corto plazo) y a 5 años (Markov). Se incluyeron las complicaciones de la TEV (trombosis venosa profunda distal y proximal, embolia pulmonar, sangrados y síndrome postrombótico). La eficacia comparada se obtuvo de un metaanálisis y los costes de fuentes españolas. Se aplicó una tasa de descuento del 3,5% anual para costes y beneficios. Resultados. Según el metaanálisis, el riesgo relativo (RR) de TEV o muerte, frente a enoxaparina, fue menor con apixaban que con dabigatrán en ATR (RR: 0,89; IC 95% 0,32-1,65 y RR: 1,35, IC 95% 0,19-3,39) y en ATC (RR: 0,35, IC 95% 0,05-2,51 y RR: 0,89, IC 95% 0,22-3,21, respectivamente). A corto plazo, con apixaban se obtendrían más años de vida (AVG) y más años de vida ajustados por calidad (AVAC) por paciente, tanto en ATR (0,2037; 0,1908) como en ATC (0,2417; 0,1921) que con dabigatrán (0,1818; 0,1901, y 0,2345; 0,1918, respectivamente). Habría menos costes por paciente con apixaban en ATR (-14 €) por lo que este sería el tratamiento dominante. En ATC se producirían costes adicionales (15 €) con un coste por AVG de 2.083 y de 50.000 € por AVAC ganado. A 5 años, apixaban fue más barato y más efectivo en ATR y en ATC. Conclusiones. Según el presente estudio, apixaban es un tratamiento coste-efectivo en comparación con dabigatrán en la prevención de la TEV (AU)

Objective. Cost-effectiveness analysis of apixaban vs. dabigatran in preventing venous thromboembolism (VTE) in total knee (TKR) or hip (THR) replacement. Methods. Model with two periods: post-prophylaxis period of 90 days (short term) and 5 years (Markov). VTE complications (distal and proximal deep vein thrombosis, pulmonary embolism, bleeding and post-thrombotic syndrome) were included. The comparative efficacy was obtained from a meta-analysis, and the costs from Spanish sources. An annual discount rate of 3.5% for costs and benefits was applied. Results. According to the meta-analysis, the relative risk (RR) of VTE or death, compared with enoxaparin, was lower with apixaban than with dabigatran in TKR (RR 0.89, 95% CI 0.32 to 1.65 and RR 1.35, 95% CI, 0.19 to 3.39) and THR (RR 0.35, 95% CI, 0.05 to 2.51 and RR 0.89, 95% CI 0.22 to 3.21, respectively). In the short term, there were more life years (LYG) and more quality-adjusted life years (QALY) per patient in TKR (0.2037; 0.1908) and THR (0.2417; 0.1921) with apixaban than with dabigatran (0.1818; 0.1901 and 0.2345; 0.1918, respectively) were obtained. With apixaban lower costs per patient in TKR (-14 €) were generated, so it was the dominant treatment. Additional costs (15 €) could be incurred in THR, with a cost per LYG of 2,083 € and 50,000 € per QALY gained. In 5 years, apixaban was cheaper and more effective in both TKR and THR. Conclusions. According to this study, apixaban was shown to be a cost-effective treatment compared with dabigatran for VTE prevention (AU)

Utilización de recursos sanitarios y costes asociados al diagnóstico y tratamiento de cada episodio de trombosis venosa profunda y sangrado en pacientes intervenidos de cirugía ortopédica de cadera o rodilla / Use of health resources and costs associated with the diagnosis and treatment of each episode of deep vein thrombosis and bleeding in patients undergoing orthopaedic surgery for hip or knee

Objetivo. Conocer la utilización de recursos sanitarios y los costes asociados al diagnóstico y tratamiento de la trombosis y sangrado en pacientes intervenidos de artroplastia primaria total de cadera (ATC) o rodilla (ATR), durante 3 meses de seguimiento. Pacientes y método. Estudio observacional de carácter multicéntrico y retrospectivo, realizado a partir de los registros médicos de pacientes pertenecientes a 3 centros hospitalarios-públicos españoles (año 2010). Se consideraron aleatoriamente 3 grupos de pacientes: a) control (sin complicaciones hospitalarias); b) sangrado, y c) trombosis. Se incluyeron variables generales, de utilización de recursos y sus costes. Análisis estadístico: regresión logística y ANCOVA, p<0,05. Resultados. Se incluyeron pacientes ≥ 40 años y que hubieran recibido profilaxis anticoagulante. Se incluyó un total de 141 pacientes (control: 60; sangrado: 60; y trombosis: 21). La edad media fue de 68,7 (DE: 10,4) años y el 68,1% fueron mujeres. La ATR fue la técnica más frecuente (71,6%). El riesgo de sangrado se relacionó con la edad (OR=1,1) y el de trombosis con la EPOC (OR=1,8), p<0,05. El promedio de días de estancia de los grupos de trombosis, sangrado y control fue de 13,9; 11,5 y 7,4 días, respectivamente, p<0,001). Los costes totales fueron: 10.484,3 €; 8.766,4 €, y 6.496,1 €, respectivamente, p<0,05. Todos los resultados agrupados fueron comparables entre ellos según el hospital analizado y el tipo de artroplastia. Conclusiones. Los costes más elevados se producen en los pacientes que habían desarrollado una trombosis y sangrado, respectivamente. Los costes se relacionaron con la prolongación de los días de estancia y las infecciones intrahospitalarias (AU)

Objective. To determine the use of healthcare resources and costs associated with the diagnosis and treatment of thrombosis and bleeding patients who have undergone elective hip or knee replacement surgery, in routine clinical practice conditions. Patients and methods. This multicentre observational and retrospective study extracted data from the medical records of three Spanish public hospitals (2010). Patients ≥ 40 years who had received prophylaxis-anticoagulation were included. They were randomised into three groups: a) control (no hospital complications), b) bleeding, and c) thrombosis. General variables, use of resources and costs were analysed. Statistical analysis: logistic regression and ANCOVA for model correction, (P<.05) was included. Results. A total of 141 patients (control: 60; bleeding: 60; and thrombosis: 21), with a mean age 68.7 (SD: 10.4) years, and 68.1% females were identified. Hip arthroplasty was more frequent (71.6%). The bleeding risk was associated with age (OR=1.1) and thrombosis with COPD (OR=1.8); P<.05). The average length of stay for the thrombosis, bleeding and control groups was 13.9, 11.5 and 7.4 days, respectively; P<.001). The total costs for each group were €10,484.3; €8,766.4 and €6,496.1 respectively; P<.05. All grouped results were comparable between them according to the hospital analysed and the type of replacement. Conclusions. Costs were higher for thrombosis and bleeding patients, respectively. Costs were associated with length of stay and hospital-acquired infections (AU)

[Use of health resources and costs associated with the diagnosis and treatment of each episode of deep vein thrombosis and bleeding in patients undergoing orthopaedic surgery for hip or knee]. / Utilización de recursos sanitarios y costes asociados al diagnóstico y tratamiento de cada episodio de trombosis venosa profunda y sangrado en pacientes intervenidos de cirugía ortopédica de cadera o rodilla.

OBJECTIVE: To determine the use of healthcare resources and costs associated with the diagnosis and treatment of thrombosis and bleeding patients who have undergone elective hip or knee replacement surgery, in routine clinical practice conditions. PATIENTS AND METHODS: This multicentre observational and retrospective study extracted data from the medical records of three Spanish public hospitals (2010). Patients ≥ 40 years who had received prophylaxis-anticoagulation were included. They were randomised into three groups: a) control (no hospital complications), b) bleeding, and c) thrombosis. General variables, use of resources and costs were analysed. STATISTICAL ANALYSIS: logistic regression and ANCOVA for model correction, (P<.05) was included. RESULTS: A total of 141 patients (control: 60; bleeding: 60; and thrombosis: 21), with a mean age 68.7 (SD: 10.4) years, and 68.1% females were identified. Hip arthroplasty was more frequent (71.6%). The bleeding risk was associated with age (OR=1.1) and thrombosis with COPD (OR=1.8); P<.05). The average length of stay for the thrombosis, bleeding and control groups was 13.9, 11.5 and 7.4 days, respectively; P<.001). The total costs for each group were €10,484.3; €8,766.4 and €6,496.1 respectively; P<.05. All grouped results were comparable between them according to the hospital analysed and the type of replacement. CONCLUSIONS: Costs were higher for thrombosis and bleeding patients, respectively. Costs were associated with length of stay and hospital-acquired infections.

[Cost-effectiveness analysis of apixaban compared to dabigatran in the prevention of venous thromboembolism in patients subjected to total knee or hip replacement]. / Análisis coste-efectividad de apixaban frente a dabigatrán en la prevención de la tromboembolia venosa en pacientes intervenidos de artroplastia total de rodilla o de cadera.

OBJECTIVE: Cost-effectiveness analysis of apixaban vs. dabigatran in preventing venous thromboembolism (VTE) in total knee (TKR) or hip (THR) replacement. METHODS: Model with two periods: post-prophylaxis period of 90 days (short term) and 5 years (Markov). VTE complications (distal and proximal deep vein thrombosis, pulmonary embolism, bleeding and post-thrombotic syndrome) were included. The comparative efficacy was obtained from a meta-analysis, and the costs from Spanish sources. An annual discount rate of 3.5% for costs and benefits was applied. RESULTS: According to the meta-analysis, the relative risk (RR) of VTE or death, compared with enoxaparin, was lower with apixaban than with dabigatran in TKR (RR 0.89, 95% CI 0.32 to 1.65 and RR 1.35, 95% CI, 0.19 to 3.39) and THR (RR 0.35, 95% CI, 0.05 to 2.51 and RR 0.89, 95% CI 0.22 to 3.21, respectively). In the short term, there were more life years (LYG) and more quality-adjusted life years (QALY) per patient in TKR (0.2037; 0.1908) and THR (0.2417; 0.1921) with apixaban than with dabigatran (0.1818; 0.1901 and 0.2345; 0.1918, respectively) were obtained. With apixaban lower costs per patient in TKR (-14 €) were generated, so it was the dominant treatment. Additional costs (15 €) could be incurred in THR, with a cost per LYG of 2,083 € and 50,000 € per QALY gained. In 5 years, apixaban was cheaper and more effective in both TKR and THR. CONCLUSIONS: According to this study, apixaban was shown to be a cost-effective treatment compared with dabigatran for VTE prevention.

Análisis de costes del tratamiento de la diabetes mellitus tipo 2 con insulina glargina o detemir / Costs analysis of type 2 diabetes mellitus treatment with insulin glargine or detemir

Introducción: Diversos estudios publicados han revelado que algunos pacientesque inician el tratamiento con insulina detemir, cuya administraciónrecomendada es de una vez al día, requieren finalmente una administracióndos veces al día para optimizar el control de la glucosa sanguínea. Los resultadosclínicos se han evaluado en esta población seleccionada mediante unensayo clínico aleatorizado. Objetivo: Comparar los costes de dos tratamientoscon insulina (glargina y detemir) en la diabetes mellitus tipo 2 en pacientesno controlados con antidiabéticos orales. Métodos: Análisis de compensaciónde costes sanitarios, modelizado desde la perspectiva del Sistema Nacional deSalud español (considerando únicamente los costes directos sanitarios). Sesimuló la utilización de los recursos asociados al tratamiento de la diabetestipo 2 con glargina y detemir, respecto a las dosis de insulina administradas, lautilización de tiras reactivas para el autoanálisis de la glucemia y el consumode agujas desechables. Las dosis de glargina y detemir se obtuvieron de unensayo clínico que comparó ambas insulinas durante 24 semanas. La utilizaciónde tiras reactivas y de agujas desechables se estimó de acuerdo con lapráctica clínica en España. Los costes unitarios se tomaron de fuentes y basesde datos españolas. Resultados: En los pacientes tratados con glargina seadministró una menor dosis diaria de insulina que con detemir y, por tanto, seprodujo un menor coste diario del tratamiento insulínico, así como un menorconsumo de tiras reactivas y agujas. En consecuencia, la utilización de glarginaen lugar de detemir se asociaría a un ahorro anual de 765,03 € por pacientecon diabetes tipo 2, lo que supone un ahorro de un 43,3% con glarginafrente a detemir. En el análisis de sensibilidad, el ahorro anual por pacientetratado con glargina osciló entre 646,05 y 810,55 €(AU)

Conclusiones: Deacuerdo con el presente modelo, en la población estudiada la insulina glarginaes un tratamiento de la diabetes tipo 2 más coste-efectiva que la insulina detemiry se asocia a unos menores costes anuales de tratamiento(AU)

Introduction: Large published data suggested that some patients initiatingwith the recommended once daily insulin detemir administration require twicedaily dosing to optimise blood glucose control. Therefore the clinical outcomein this selected population was tested in a randomized controlled trial. Objective:To compare the costs of two treatments of type 2 diabetes mellitus, insulinglargine and insulin detemir, in patients with type 2 diabetes not controlledwith oral antidiabetic agents. Methods: Costs-offset analysis was modelledfrom the Spanish National Health System perspective, taking into account thehealth direct costs. A simulation of resources use related with glargine and detemirin type 2 diabetes treatment was performed, taking into account insulinadministered doses, utilization of test strips for glycemia control and disposableneedles used. The glargine and detemir doses were obtained from one clinicaltrial comparing both insulins for 24 weeks. The test strips and disposableneed les use were estimated from the Spanish clinical practice. Unit costs weretaken from Spanish sources and databases. Results: Lower daily doses were administeredwith glargine than with detemir. Therefore, the use of glargine insteaddetemir would result in a lower daily cost of insulin treatment, and alower use of test strips and disposable needles. As a consequence, the glargineuse would result in an annual saving of 765.03 € for a patient with type 2diabetes, 43.3% savings with glargine versus detemir. According to the sensitivityanalysis, the annual saving for a patient treated with glargine was between646.05 and 810.55 €. Conclusions: According to this model, in the abovementioned population, glargine insulin is a more cost-effective treatment thandetemir insulin, with lower annual treatment costs(AU)