Initial monotherapy with eslicarbazepine acetate for the management of adult patients with focal epilepsy in clinical practice: a meta-analysis of observational studies.

AIM OF THE STUDY: To assess the effectiveness, overall tolerability of eslicarbazepine acetate (ESL) as an initial or early monotherapy treatment of adult patients with focal epilepsy under real-world practice conditions. MATERIALS AND METHODS: We focused on real-world longitudinal studies that included or separately reported the results of at least one of the efficacy outcomes of interest. A DerSimonian-Laird random effects model was used with the presentation of the 95% confidence intervals of the estimate. RESULTS: 5 studies met our selection criteria and were included in the quantitative synthesis. All studies were observational and uncontrolled studies, and all but one were retrospective studies. The pooled proportion of patients who were seizure-free for the entire study period was 64.6% (95% CI, 45.7 to 79.8) at month 6 and 56.6% (95% CI, 50.2 to 62.8) at month 12. Pooled retention rates were 95.0% (95% CI, 90.3 to 97.5) at 6 months and 83.6% (95% CI, 73.9 to 90.1) at 12 months. The pooled proportion of patients who reported at least one adverse event was 27.2% (95% CI, 21.7 to 33.6), and the pooled proportion of patients who discontinued ESL due to adverse events was 8.9% (95% CI 6.2 to 12.6). CONCLUSIONS: Our results suggest that initial or early monotherapy with ESL is effective and well-tolerated for the management of adult patients with focal epilepsy in clinical practice, with results that are at least similar to those reported in the pivotal randomized clinical trial of ESL monotherapy. No new safety signals with ESL have been identified in this systematic review.

Control de factores de riesgo cardiovascular en pacientes diabéticos revascularizados: un subanálisis del estudio ICP- Bypass / Control of cardiovascular risk factors in revascularized patients with diabetes: A subanalysis of the ICP-bypass study

Introducción y objetivos Los diabéticos tipo 2 con enfermedad coronaria revascularizada son un grupo de muy alto riesgo cardiovascular poco estudiado. Este subanálisis del estudio ICP-Bypass analiza sus características clínicas y el control de factores de riesgo. Métodos Se seleccionó a los diabéticos tipo 2 procedentes de un estudio previo multicéntrico, observacional y transversal (ICP-Bypass) realizado en 2.293 pacientes > 18 años sometidos a cirugía coronaria o intervencionismo coronario percutáneo. Se recogieron y analizaron de manera comparativa variables demográficas y terapéuticas, así como los parámetros clínicos y analíticos. Resultados La edad media ± desviación estándar de los 771 diabéticos fue 67,7 ± 9,6 años (el 71,4% varones; tiempo medio desde la revascularización, 3,5 años). La mayoría (57,8%) recibía tratamiento con antidiabéticos orales solos y el 30,4% recibían insulina sola o combinada. La media de glucohemoglobina fue del 7,1% (en el 70%, < 7,5%). El 74,8% tenía diagnóstico de dislipemia. El colesterol unido a lipoproteínas de baja densidad medio fue 93,5 mg/dl (el 73%, > 70 mg/dl). Se administraban estatinas al 93,6 y el 18,7% recibía una estatina combinada con ezetimiba. Del 78,1% con diagnóstico de hipertensión, el 52% tenía presión arterial sistólica/diastólica < 130/80 mmHg y el 93%, < 140/90 mmHg. Conclusiones En el manejo del riesgo y la prevención cardiovascular de los pacientes diabéticos revascularizados en España se observa margen de mejora en el control de factores de riesgo, fundamentalmente la dislipemia. La existencia de pacientes con glucohemoglobina > 7,5% requeriría la evaluación individual de los objetivos de control glucémico (AU)

Introduction and objectives Patients with type 2 diabetes and revascularized coronary disease are a group with very high cardiovascular risk that has been rarely studied. This ICP-Bypass substudy analyzes the clinical characteristics and risk factor control of these patients. Methods The analysis selected patients with type 2 diabetes who had participated in an earlier multicenter, observational, cross-sectional study (ICP-Bypass) conducted in 2293 patients > 18 years of age who had undergone coronary surgery or percutaneous coronary intervention. Demographic and therapeutic variables, as well as clinical and analytical parameters, were collected and comparatively analyzed. Results The mean age (standard deviation) of the 771 diabetic patients included in the analysis was 67.7 (9.6) years (71.4% men; mean time since revascularization, 3.5 years). Most (57.8%) were receiving treatment with oral hypoglycemics alone, whereas 30.4% were receiving insulin alone or in combination. The mean glycohemoglobin figure was 7.1% (in 70%, < 7.5%); 74.8% had been diagnosed with dyslipidemia. Mean low-density lipoprotein cholesterol was 93.5 mg/dL (in 73%, > 70 mg/dL). Among these patients, 93.6% were receiving statins and 18.7% a statin combined with ezetimib. A total of 78.1% had been diagnosed with hypertension; systolic/diastolic blood pressure was < 130/80 mmHg in 52% and < 140/90 mmHg in 93%.ConclusionsCardiovascular risk and prevention may be improved in revascularized diabetic patients in Spain through further control of risk factors, particularly dyslipidemia. Patients with glycohemoglobin > 7.5% should be individually assessed in terms of glycemic targets (AU)

Control of cardiovascular risk factors in revascularized patients with diabetes: a subanalysis of the ICP-Bypass study.

INTRODUCTION AND OBJECTIVES: Patients with type 2 diabetes and revascularized coronary disease are a group with very high cardiovascular risk that has been rarely studied. This ICP-Bypass substudy analyzes the clinical characteristics and risk factor control of these patients. METHODS: The analysis selected patients with type 2 diabetes who had participated in an earlier multicenter, observational, cross-sectional study (ICP-Bypass) conducted in 2293 patients > 18 years of age who had undergone coronary surgery or percutaneous coronary intervention. Demographic and therapeutic variables, as well as clinical and analytical parameters, were collected and comparatively analyzed. RESULTS: The mean age (standard deviation) of the 771 diabetic patients included in the analysis was 67.7 (9.6) years (71.4% men; mean time since revascularization, 3.5 years). Most (57.8%) were receiving treatment with oral hypoglycemics alone, whereas 30.4% were receiving insulin alone or in combination. The mean glycohemoglobin figure was 7.1% (in 70%,<7.5%); 74.8% had been diagnosed with dyslipidemia. Mean low-density lipoprotein cholesterol was 93.5 mg/dL (in 73%, > 70 mg/dL). Among these patients, 93.6% were receiving statins and 18.7% a statin combined with ezetimib. A total of 78.1% had been diagnosed with hypertension; systolic/diastolic blood pressure was < 130/80 mmHg in 52% and < 140/90 mmHg in 93%. CONCLUSIONS: Cardiovascular risk and prevention may be improved in revascularized diabetic patients in Spain through further control of risk factors, particularly dyslipidemia. Patients with glycohemoglobin > 7.5% should be individually assessed in terms of glycemic targets.

[Cross-sectional epidemiological study of clinical profiles and glycemic control in diabetic patients in primary care in Spain (the EPIDIAP study)]. / Estudio epidemiológico del perfil clínico y control glucémico del paciente diabético atendido en centros de atención primaria en España (estudio EPIDIAP).

OBJECTIVE: To assess the degree of glycemic control and its associated factors in patients with diabetes mellitus (DM) attended by primary care teams in Spain. MATERIAL AND METHODS: A cross-sectional multicenter study was carried out using a structured questionnaire in diabetic patients consecutively attended from January to August 2007. Three groups were assessed: patients with type 1 diabetes mellitus (DM) and those with insulin-treated or non-insulin-treated type 2 DM. The diagnosis of DM was established according to the American Diabetes Association (ADA) criteria. Good glycemic control was defined as a glycated hemoglobin (HbA1c) value

Estudio epidemiológico del perfil clínico y control glucémico del paciente diabético atendido en centros de atención primaria en España (estudio EPIDIAP) / Cross-Sectional epidemiological study of clinical profiles and glycemic control in diabetic patients in primary care in Spain (the epidiap study)

Objetivo: Estimar el grado de control glucémico y los factores relacionados en pacientes con diabetes mellitus (DM) atendidos por equipos de atención primaria de todo el territorio español. Material y métodos: Diseño transversal multicéntrico, realizado a partir de un cuestionario estructurado aplicado a sujetos diabéticos atendidos consecutivamente durante el periodo enero-agosto de 2007. Se analizaron 3 grupos: diabetes mellitus tipo 1 (DM1), DM2 no tratados con insulina y DM2 en tratamiento con insulina. El diagnóstico de DM se realizó según criterios de la American Diabetes Association (ADA). El grado de control satisfactorio se estableció en glucohemoglobina (HbA1c) = 7%. Se recogieron variables sociodemográficas y clínicas, antecedentes personales y complicaciones clínicas. Los factores asociados al control se estudiaron mediante análisis de regresión logística múltiple. Resultados: Se reclutó a 679 pacientes, clasificados en DM1 (11,5%), DM2 con insulina (26,2%) y DM2 no tratados con insulina (62,3%). La media de edad fue 65,2 ± 13,7 años; el 52,4% eran mujeres; el 35,6% tenía obesidad; el 86%, dislipemia, y el 78,9%, hipertensión. El 53,1% (intervalo de confianza, 49,3-56,9) tuvo un control satisfactorio (por grupos: el 31,5, el 32,7 y el 65,4% respectivamente; p < 0,001). Como factores predictivos del control insatisfactorio se hallaron: edad (odds ratio [OR] = 0,984), el tiempo de evolución (OR = 1,033) y el tratamiento con insulina (OR = 4,054) (p < 0,001). El 5,8% de los sujetos cumplían todos los objetivos recomendados por la ADA. Conclusiones: El control glucémico de los pacientes es mejorable. Sólo 1 de cada 2 pacientes con DM atendidos en atención primaria presenta un control glucémico adecuado. El porcentaje de pacientes con un control glucémico satisfactorio en el grupo de pacientes en tratamiento con insulina (tipo 1 y 2) fue la mitad que el de los pacientes no tratados con insulina (AU)

Objective: To assess the degree of glycemic control and its associated factors in patients with diabetes mellitus (DM) attended by primary care teams in Spain. Material and methods: A cross-sectional multicenter study was carried out using a structured questionnaire in diabetic patients consecutively attended from January to August 2007. Three groups were assessed: patients with type 1 diabetes mellitus (DM) and those with insulin-treated or non-insulin-treated type 2 DM. The diagnosis of DM was established according to the American Diabetes Association (ADA) criteria. Good glycemic control was defined as a glycated hemoglobin (HbA1c) value = 7%. Sociodemographic characteristics, medical history, and clinical complications were collected. Factors associated with glycemic control were analyzed by means of multiple logistic regression analysis. Results: A total of 679 patients were included, classified into type 1 DM (11.5%), insulin-treated type 2 DM (26.2%) and non-insulin-treated type 2 DM (62.3%). The mean age was 65.2 ± 13.7 years, 52.4% were women, 35.6% were obese, 86.0%, were dyslipidemic and 78.9% had hypertension. A total of 53.1% (CI: 49.356.9) showed good glycemic control (distribution among groups: 31.5%, 32.7% and 65.4%, respectively; p < 0.001). Predictive factors for unsatisfactory control were age (odds ratio [OR] = 0.984), time from diagnosis (OR = 1.033) and insulin treatment (OR = 4.054) (p < 0.001). Only 5.8% of the individuals achieved all the objectives recommended by the American Diabetes Association. Conclusions: Glycemic control in diabetic patients can be improved. Only one in two patients with diabetes attended in primary care is properly controlled. The percentage of patients with satisfactory control in the insulin-treated group (types 1 and 2) was half that in the non-insulin-treated group (AU)