Gender differences in antithrombotic treatment in patients with atrial fibrillation from Spain versus the rest of Western Europe. GLORIA-AF Program

Background and objective:Thromboembolic risk is higher in women than men with non-valvular atrial fibrillation (NVAF). Published data indicate variability in antithrombotic use by gender and region. We analyzed gender-specific antithrombotic treatment patterns in Spain and rest of Western Europe (rWE) in patients with NVAF.Methods:GLORIA-AF (Phase III) is a global, prospective, observational study which enrolled newly diagnosed NVAF patients with CHA2DS2-VAScs≥1 (2014–2016). Analyses were performed comparing antithrombotic treatments by gender in Spain and rWE.Results:This analysis included 1163 and 7972 patients from Spain and rWE, respectively. Stroke risk was higher in women than men in both Spain and rWE. While in rWE, bleeding risk and antithrombotic treatment pattern were similar between genders, in Spain bleeding risk in women was lower and more females compared to men received OACs (95.0% versus 92.4%, d=−0.1078, respectively). Fewer Spanish patients received direct oral anticoagulants (DOACs) (women 32.1%, men 25.3%) than vitamin-K-antagonists (VKAs) (women 63.0%, men 67.1%) vs. rWE patients. In Spain women received more DOACs compared to men (56.0% versus 44.0%).Conclusions:OAC rates were higher in Spain as compared to rWE. More women received OACs in Spain, while in rWE no difference by gender was observed. DOACs in rWE are the most prescribed OAC while in Spain, due to prescription barriers, its use remains low for both genders and VKAs are preferred. Spanish women received more DOACs compared to men. (NCT01468701). (AU)

Antecedentes y objetivo:El riesgo tromboembólico es mayor en mujeres que en varones con fibrilación auricular no valvular (FANV). Existen diferencias en el uso de anticoagulantes (ACO) según sexo y zona geográfica. Se estudiaron los patrones de anticoagulación por sexo en España y el resto de Europa Occidental (rEO) en pacientes con FANV.Métodos:GLORIA-AF es un estudio observacional prospectivo (fase III) que incluyó a pacientes con diagnóstico reciente de FANV y CHA2DS2-VASc>1 (2014-2016). Se analizó la prescripción de anticoagulantes por sexo en España y el rEO.Resultados:Se incluyó a 1.163 pacientes de España y 7.972 del rEO. El riesgo de ictus fue superior en mujeres tanto en España como en el rEO. El riesgo de hemorragia y el tratamiento antitrombótico fueron similares en ambos sexos en el rEO; en España, el riesgo de hemorragia fue menor en mujeres y estas recibieron más ACO que los varones (95,0% vs. 92,4%, d=–0,1078). En España, menos pacientes recibieron ACO directos (ACOD) (mujeres 32,1%, varones 25,3%) vs. antagonistas de la vitamina K (AVK) (mujeres 63,0%, varones 67,1%), y las mujeres recibieron más ACOD que los varones (56,0% vs. 44,0%).Conclusiones:En España se emplearon más ACO que en el rEO y más mujeres fueron tratadas con ACO, mientras que en el rEO no hubo diferencias por sexo. En el rEO, los ACOD se emplearon más. En España, los ACOD se emplean menos por restricciones de prescripción y se emplean más los AVK. Las mujeres españolas reciben más ACOD que los varones. (NCT01468701). (AU)

Gender differences in antithrombotic treatment in patients with atrial fibrillation from Spain versus the rest of Western Europe. GLORIA-AF Program.

BACKGROUND AND OBJECTIVE: Thromboembolic risk is higher in women than men with non-valvular atrial fibrillation (NVAF). Published data indicate variability in antithrombotic use by gender and region. We analyzed gender-specific antithrombotic treatment patterns in Spain and rest of Western Europe (rWE) in patients with NVAF. METHODS: GLORIA-AF (Phase III) is a global, prospective, observational study which enrolled newly diagnosed NVAF patients with CHA2DS2-VAScs≥1 (2014-2016). Analyses were performed comparing antithrombotic treatments by gender in Spain and rWE. RESULTS: This analysis included 1163 and 7972 patients from Spain and rWE, respectively. Stroke risk was higher in women than men in both Spain and rWE. While in rWE, bleeding risk and antithrombotic treatment pattern were similar between genders, in Spain bleeding risk in women was lower and more females compared to men received OACs (95.0% versus 92.4%, d=-0.1078, respectively). Fewer Spanish patients received direct oral anticoagulants (DOACs) (women 32.1%, men 25.3%) than vitamin-K-antagonists (VKAs) (women 63.0%, men 67.1%) vs. rWE patients. In Spain women received more DOACs compared to men (56.0% versus 44.0%). CONCLUSIONS: OAC rates were higher in Spain as compared to rWE. More women received OACs in Spain, while in rWE no difference by gender was observed. DOACs in rWE are the most prescribed OAC while in Spain, due to prescription barriers, its use remains low for both genders and VKAs are preferred. Spanish women received more DOACs compared to men. (NCT01468701).

[Study of patients with gout: clinical features in the last 2 years of monitoring]. / Estudio de pacientes con gota: características clínicas en los últimos 2 años de seguimiento.

OBJECTIVE: to analyze the clinical characteristics of gout patients with < 3 attacks and ≥ 3 acute attacks per year. METHODS: retrospective observational study carried out at 6-primary care (AP) and 2 hospitals. We included patient's ≥ 18 years during the years 2003-2007 inclusive. The study groups were: patients with 1-2 and ≥ 3 attacks/acute recurrences.The main variables: demographic, metabolic syndrome (MS), clinical features and treatment. STATISTICAL ANALYSIS: logistic regression model, p < 0.05. RESULTS: 3,130 patients were included. The mean age was 55.8 years and 81.1% were male:31.6% have ≥ 3 attacks per year. The prevalence of MS was 28.8% (CI: 27.2-30.4%) in patients with 1-2 attacks. Subjects with ≥ 3 acute attacks were associated with: MS (OR: 6.2; CI: 4.6-8.3; 65.8 vs. 11.8%), obesity (OR: 2.1; CI: 1.7-2.5;63.5 vs. 33.8%) and hypertension (OR: 1.6; CI: 1.3-1.9; 58.3 vs. 36.9%), p < 0.001; 58.4% continued to take allopurinol(50.3 vs. 62.2%; p < 0.001). CONCLUSIONS: patients with ≥ 3 attacks per year have a more severe disease with acute poly-articular, tophi and higher number of co-morbidities. It is important to control uric acid to reduce the recurrence of attacks in these patients.

Comunicación de los resultados de la investigación observacional: análisis mediante la guía Strobe / The reporting of observational studies: analysis using the STROBE statement

Fundamento: En la publicación de la investigación biomédica se detectan deficiencias que han llevado a la aparición de guías cuyo seguimiento mejora la calidad de la comunicación. El objetivo del estudio es analizar el cumplimiento de los criterios de la Iniciativa Strobe para la publicación de estudios observacionales. Métodos: Análisis descriptivo transversal de los estudios observacionales de las áreas Cardiovascular y Metabolismo (CVM) publicados en 6 revistas españolas a lo largo de 2009 mediante la aplicación de los 34 puntos de la Iniciativa STROBE. Se describieron las frecuencias de las variables cualitativas y los estimadores muestrales y de dispersión de las variables cuantitativas. El análisis comparativo entre revistas se realizó mediante el test ANOVA (p<0,05). Resultados: En 2009 se publicaron 74 estudios observacionales en las revistas evaluadas. Los más frecuentes fueron estudios de cohortes 45 (60,8%) y transversales 28 (37,8%). En cuanto al objetivo principal, la mayoría fueron sobre patología 55 (74,3%), seguidos de fármacos e intervenciones no farmacológicas 15 (20,3%) y diagnóstico 4 (5,4%). La media de criterios cumplidos fue de 20 sobre 34 (DE±3,7), con un máximo de 24 (DE±2) en Gaceta Sanitaria y un mínimo de 19 (DE±2,8) en Hipertensión. Conclusiones: Solo algo más de la mitad de los artículos cumplían las recomendaciones de la Iniciativa STROBE. Los apartados de Resultados y Métodos fueron los que mostraron más carencias(AU)

Background: Deficiences detected in biomedical studies publication have led to develop different Guidelines to improve communication’s quality. The objective of the study is to assess the communication of observational studies of Cardiovascular and Metabolism therapeutic area (CVM) published in 6 Spanish journals in 2009 using the STROBE statement. Methods: Cross-sectional analysis of articles related to CVMtherapeutic area, published during 2009 in 6 Spanish journals applying the 34 items of the STROBE statement. Descriptive analysis of the results for qualitative variables was performed using a frequency analysis. Quantitative variables were analyzed by sample estimates and dispersion. A comparative analysis of journals was performed using ANOVA with a statistical significance of p<0.05. Results: Throughout 2009, 74 CVM observational studies were published in the evaluated journals. The most frequent design were cohorts 45 (60.8%) and cross-sectional 28 (37.8%). The study main objective was on pathology 55 (74.3%), followed by drug and non-pharmacological interventions 15 (20.3%) and diagnosis 4 (5.4%). Themean of complied items was 20 on 34 (DE±3.7), with a maximum of 24 (DE±2) in Gaceta Sanitaria and a minimum of 19 (DE±2.8) in Hipertensión. Conclusions: Evaluated papers comply with slightly more than a half items (58%) of the STROBE recommendations. The Methods and Results sections showed more deficiencies(AU)

Influencia del cumplimiento asociado a la incidencia de eventos cardiovasculares y los costes en combinaciones a dosis fijas en el tratamiento de la hipertensión arterial / Influence of compliance on the incidence of cardiovascular events and health costs when using single-pill fixed-dose combinations for the treatment of hypertension

Fundamento y objetivo: Determinar la incidencia de eventos cardiovasculares (ECV) y costes sanitarios en función del cumplimiento, persistencia y control de la presión arterial, comparando pacientes consumidores de dosis-fijas (DF) frente a dosis-libres (DL) en el tratamiento de la hipertensión arterial (HTA).Pacientes y método: Diseño observacional-multicéntrico. Se incluyeron pacientes>30 años que iniciaron tratamiento farmacológico (año 2006). Se establecieron dos grupos de estudio: DF (inhibidores de la enzima convertidora de angiotensina/diuréticos [IECA/DIU]; antagonistas de los receptores de angiotensina de tipo II [ARA II]/DIU) y DL (IECA+DIU; ARA II+DIU, por separado). Se recogieron variables sociodemográficas, comorbilidad, parámetros bioquímicos, cumplimiento y persistencia (según criterios ESH-ESC). Se determinó la incidencia acumulada de ECV y un modelo de costes totales (diferenciando sanitarios/directos y no-sanitarios/indirectos). El seguimiento de los pacientes se realizó durante dos años. Se realizó un análisis estadístico que incluyó regresión-logística, riesgos proporcionales y ANCOVA. Resultados: Se reclutaron 1.605 pacientes, 1.112 (69,3%) en DF y 493 (30,7%) en DL (p<0,001). La edad media (DE) fue de 69,4 (12,2) años y un 55,5% eran mujeres. Las DF mostraron un mejor cumplimiento (77,6 frente a 71,9; p<0,001) y persistencia del tratamiento (62,1%, intervalo de confianza del 95% [IC 95%] 56,3-67,9%, frente al 49,7%, IC 95% 38,5-60,9%; p<0,001). El control óptimo de la presión arterial en DF fue superior (48,9% frente a 46,7%; p<0,001). La incidencia acumulada de accidente vasculocerebral en DL fue de 4,6% frente a 2,4% (p=0,041). El coste total fue menor (1.650,7 € frente a 1.674,8 €; p<0,001) en atención especializada (316,1 € frente a 382,9 €; p<0,001), ocasionando menos ingresos hospitalarios y pérdidas de productividad laboral (44,5 € frente a 88,4 €; p<0,001) (AU)

Background and objective: To determine the incidence of cardiovascular events (CVE) and health care costs in relation to compliance, persistence and level of blood pressure control when comparing patients treated with single-pill combinations (SPC) or free combinations (FC) for the treatment of hypertension. Patients and methods Observational, multicenter study that included patients>30 years old, from six primary care teams and two hospitals, who started pharmacological treatment for hypertension during 2006. Two study groups were established: SPC (ACEIs/diuretics; ARBs/diuretics) and FC (ACEIs+DIU; ARB+DIU, separately). Main variables studied were sociodemographic data, comorbidity, Charlson-index, compliance, persistence and achievement of therapeutic goals (ESH-ESC criteria). The cumulative incidence of CVE and a total-cost model were determined (differentiating: health/direct; non-health/indirect). Patients were followed for two years. Statistical analysis included logistic regression, Cox proportional hazards model and analysis of covariance. Statistical signification: p<0.05. Results: 1,605 patients were recruited, 1,112 (69.3%) receiving SPC and 493 (30.7%) receiving FC, p<0.001; mean age: 69.4 (12.2) years; women: 55.5%. FC treatments were associated with ischaemic heart disease (OR=1.4; 95% CI: 1.1-2.0) and organ failure (OR=1.5; 95% CI: 1.2-2.1), p<0.031. Patients on SPC showed better therapeutic compliance (77.6% vs 71.9%; p<0.001) and longer persistence of treatment (62.1% on-treatment at 24-months [95% CI: 56.3-67.9] vs 49.7% [95% CI: 38.5-60.9]; p<0.001). Optimal control of blood pressure was higher in SPC (48.9% [95% CI: 43.0-54.8] vs 46.7% [95% CI: 35.6-57.8]; p<0.001). Cumulative incidence of cerebrovascular accidents in FC was 4.6% vs 2.4% in SPC; p=0.041. The total health care costs were lower in SPC (1,650.7 € vs 1,674.8 €; p<0.001), including lower specialized care costs (316.1 € vs 382.9 €; p<0.001), fewer hospital admission (AU)

[Influence of compliance on the incidence of cardiovascular events and health costs when using single-pill fixed-dose combinations for the treatment of hypertension]. / Influencia del cumplimiento asociado a la incidencia de eventos cardiovasculares y los costes en combinaciones a dosis fijas en el tratamiento de la hipertensión arterial.

BACKGROUND AND OBJECTIVE: To determine the incidence of cardiovascular events (CVE) and health care costs in relation to compliance, persistence and level of blood pressure control when comparing patients treated with single-pill combinations (SPC) or free combinations (FC) for the treatment of hypertension. PATIENTS AND METHODS: Observational, multicenter study that included patients>30 years old, from six primary care teams and two hospitals, who started pharmacological treatment for hypertension during 2006. Two study groups were established: SPC (ACEIs/diuretics; ARBs/diuretics) and FC (ACEIs+DIU; ARB+DIU, separately). Main variables studied were sociodemographic data, comorbidity, Charlson-index, compliance, persistence and achievement of therapeutic goals (ESH-ESC criteria). The cumulative incidence of CVE and a total-cost model were determined (differentiating: health/direct; non-health/indirect). Patients were followed for two years. Statistical analysis included logistic regression, Cox proportional hazards model and analysis of covariance. Statistical signification: p<0.05. RESULTS: 1,605 patients were recruited, 1,112 (69.3%) receiving SPC and 493 (30.7%) receiving FC, p<0.001; mean age: 69.4 (12.2) years; women: 55.5%. FC treatments were associated with ischaemic heart disease (OR=1.4; 95% CI: 1.1-2.0) and organ failure (OR=1.5; 95% CI: 1.2-2.1), p<0.031. Patients on SPC showed better therapeutic compliance (77.6% vs 71.9%; p<0.001) and longer persistence of treatment (62.1% on-treatment at 24-months [95% CI: 56.3-67.9] vs 49.7% [95% CI: 38.5-60.9]; p<0.001). Optimal control of blood pressure was higher in SPC (48.9% [95% CI: 43.0-54.8] vs 46.7% [95% CI: 35.6-57.8]; p<0.001). Cumulative incidence of cerebrovascular accidents in FC was 4.6% vs 2.4% in SPC; p=0.041. The total health care costs were lower in SPC (1,650.7 € vs 1,674.8 €; p<0.001), including lower specialized care costs (316.1 € vs 382.9 €; p<0.001), fewer hospital admissions and less loss of labour productivity (44.5 € vs 88.4 €; p<0.001). CONCLUSIONS: Better compliance and persistence with antihypertensive fixed-dose combinations improves therapeutic control, leading to a significant reduction of cerebrovascular accidents and total health care costs.

[The reporting of observational studies: analysis using the STROBE statement]. / Comunicación de los resultados de la investigación observacional: análisis mediante la guía STROBE.

BACKGROUND: Deficiencies detected in biomedical studies publication different Guidelines to improve. The objective of the study is to assess the communication of observational studies of Cardiovascular and Metabolism therapeutic area (CVM) published in 6 Spanish journals in 2009 using the STROBE statement. METHODS: Cross-sectional analysis of articles related to CVM therapeutic area, published during 2009 in 6 Spanish journals applying the 34 items of the STROBE statement. Descriptive analysis of the results for qualitative variables was performed using a frequency analysis. Quantitative variables were analyzed by sample estimates and dispersion. A comparative analysis of journals was performed using ANOVA with a statistical significance of p<0.05. RESULTS: Throughout 2009, 74 CVM observational studies were published in the evaluated journals. The most frequent design were cohorts 45 (60.8%) and cross-sectional 28 (37.8%). The study main objective was on pathology 55 (74.3%), followed by drug and non-pharmacological interventions 15 (20.3%) and diagnosis 4 (5.4%). The mean of complied items was 20 on 34 (DE±3.7), with a maximum of 24 (DE±2) in Gaceta Sanitaria and a minimum of 19 (DE±2.8) in Hipertensión. CONCLUSIONS: Evaluated papers comply with slightly more than a half items (58%) of the STROBE recommendations. The Methods and Results sections showed more deficiencies.