Estudio ESCRYTO. Diabetes sin enfermedad cardiovascular y grado de control / ESCRYTO study. Diabetes without cardiovascular disease and level of control

ANTECEDENTES Y OBJETIVOS: La diabetes supone un importante factor de riesgo para el desarrollo de enfermedad cardiovascular, principal causa de muerte. El propósito de este estudio fue conocer el grado de control glucémico de los pacientes con diabetes tipo 2 sin enfermedad cardiovascular en España, según la determinación más reciente de hemoglobina glucosilada, así como el patrón de tratamiento antidiabético, la incidencia de episodios de hipoglucemia grave en los últimos 6 meses y el grado de control de los factores de riesgo cardiovascular, en función del género. PACIENTES Y MÉTODOS: Estudio epidemiológico nacional, multicéntrico y transversal. Participaron 800 médicos asociados a la redGDPS. RESULTADOS: Se incluyeron 1.059 pacientes, 57% varones. Edad media: 62,7 años en varones vs. 65,2 en mujeres (p < 0,001). Evolución de la diabetes: 9,4±7,5 años. HbA1c media: 7,0% en varones vs. 7,1% en mujeres (p = 0,039). Objetivo de control <7%: 47,2%. En tratamiento con metformina: 65%; inhibidores DPP-4: 62,4%; insulina basal: 14,2%. Incidencia de hipoglucemias graves en los últimos 6 meses: 1,9%. Las mujeres presentaron peor control glucémico, colesterol total, colesterol LDL, obesidad abdominal y filtrado glomerular. CONCLUSIONES: El control glucémico es peor en las mujeres incluso si ajustamos por edad y tiempo de evolución de la diabetes (p = 0,043) y por el número de hipoglucemiantes (p = 0,015). El grado de control es también peor en mujeres para la dislipidemia, obesidad abdominal y filtrado glomerular. Desde Atención Primaria es esencial una estrategia preventiva promocionando estilos de vida saludables y controlando todos los factores de riesgo vascular

BACKGROUND AND OBJECTIVES: Diabetes is a significant risk factor for the development of cardiovascular disease, which is the main cause of death. The purpose of this study was to determine the level of glycaemic control in patients with type 2 diabetes without cardiovascular disease in Spain. The data used includes the most recent determination of glycosylated haemoglobin, as well as the pattern of antidiabetic treatment, the incidence of episodes of severe hypoglycaemia in the last 6 months, and the level of control of cardiovascular risk factors, and gender. PATIENTS AND METHODS: A national, multicentre, and cross-sectional epidemiological study in which 800 doctors associated with the GDPS network participated. RESULTS: Of the total of 1,059 patients, 57% male, with a mean age of 62.7 years in men vs. 65.2 in women (P<.001). The mean onset of diabetes was 9.4±7.5 years. The mean HbA1C was 7.0% in men vs. 7.1% in women (P=.039), with the control objective of <7% being observed in 47.2%. There were 65% patients on treatment with metformin, and 62.4% on DPP-4 inhibitors, and basal insulin: 14.2%. Incidence of severe hypoglycemias in the last 6 months was 1.9%. The women had worse glycaemic control, total cholesterol, LDL cholesterol, abdominal obesity, and glomerular filtration levels. CONCLUSIONS: The glycaemic control is worse in women even if adjusted for age and time of onset of diabetes (P=.043), and for the number of hypoglycaemic agents (P=.015). The level of control is also worse in women for dyslipidaemia, abdominal obesity, and glomerular filtration. A preventive strategy promoted from Primary care on healthy lifestyles and controlling all vascular risk factors is essential

Control glucémico y de los factores de riesgo cardiovascular en los pacientes con diabetes tipo 2 con enfermedad cardiovascular en España, y su patrón de tratamiento, en función del género: estudio CODICE / Blood glucose control and cardiovascular risk factors in type 2 diabetic patients with cardiovascular disease in Spain, and its treatment pattern, according to gender: CODICE study

INTRODUCCIÓN Y OBJETIVOS: Con la implementación de la Estrategia de Promoción de la Salud y Prevención en España, el escenario reflejado en estudios previos de infracontrol de los factores de riesgo cardiovascular (FRCV) en pacientes con diabetes tipo 2 (DM2) y enfermedad cardiovascular (ECV) puede haberse modificado, por lo que nos planteamos conocer el grado de control glucémico y de otros FRCV en los pacientes con DM2 y ECV atendidos actualmente en nuestro medio, el patrón de tratamiento antidiabético y las diferencias en función del género. MATERIALES Y MÉTODOS: Estudio epidemiológico, observacional, transversal, de ámbito nacional en pacientes de ambos géneros diagnosticados de DM2 y ECV establecida. RESULTADOS: Se incluyeron 3.143 pacientes. Edad media: 69,0±10 años. La HbA1c media fue mayor en mujeres que en varones (7,4±1,1% vs. 7,3±1,2%; p < 0,05), así como el colesterol-LDL (101,5±38,1mg/dl vs. 91,1±37,5mg/dl; p < 0,001), la presión arterial sistólica (137,0mmHg vs. 135,6mmHg; p < 0,05) y el índice de masa corporal (30,7±5,4kg/m2 vs. 29,6±4,5kg/m2; p < 0,001). Los tratamientos más utilizados fueron la metformina (68,1%) y/o inhibidores-DPP4 (53,7%), sin diferencias entre géneros. CONCLUSIONES: El grado de control glucémico de los pacientes con DM2 y ECV en España es mejorable. El perfil de tratamiento no se ajusta a las recomendaciones de las guías de práctica clínica en general. Las diferencias en el control de los FRCV son peores en mujeres para lípidos y obesidad

INTRODUCTION AND OBJECTIVES: With the implementation of the Strategy of Health Promotion and Prevention in Spain, the scenario reflected in previous studies of low control of cardiovascular risk factors (CVRF) in patients with type 2 diabetes (DM2) and cardiovascular disease (CVD) can be modified. This study intends to determine the level of blood glucose control and other CVRF in patients with DM2 and CVD currently seen in clinics in Spain, as well as the pattern of antidiabetic treatment, and differences according to gender. MATERIALS AND METHODS: An epidemiological, observational, cross-sectional, nationwide study was conducted in patients of both genders diagnosed with DM2 and established CVD. RESULTS: The study included 3,143 patients with a mean age 69.0±10 years. The mean HbA1c was 7.4±1.1% in females vs 7.3±1.2% in males (P<.05) and systolic blood pressure was 137±15.0mmHg in females vs 135.6±14.7mmHg in males (P<.05). The mean LDL-cholesterol was 101.5±38.1mg/dl in females vs 91.1±37.5mg/dl in males; P<.001) and the mean body mass index (30.7±5.4kg/m2 in females vs 29.6±4.5kg/m2 in males; P<.001). The most used treatments were metformin (68.1%) and/or DPP4 inhibitors (53.7%), with no differences between genders. CONCLUSIONS: The level of blood glucose control of DM2 patients with CVD in Spain can be improved. The treatment profile does not conform to the recommendations of clinical practice guidelines in general. The differences in the control of CVRF are worse in women for lipids and obesity

[Blood glucose control and cardiovascular risk factors in type 2 diabetic patients with cardiovascular disease in Spain, and its treatment pattern, according to gender: CODICE study]. / Control glucémico y de los factores de riesgo cardiovascular en los pacientes con diabetes tipo 2 con enfermedad cardiovascular en España, y su patrón de tratamiento, en función del género: Estudio CODICE.

INTRODUCTION AND OBJECTIVES: With the implementation of the Strategy of Health Promotion and Prevention in Spain, the scenario reflected in previous studies of low control of cardiovascular risk factors (CVRF) in patients with type 2 diabetes (DM2) and cardiovascular disease (CVD) can be modified. This study intends to determine the level of blood glucose control and other CVRF in patients with DM2 and CVD currently seen in clinics in Spain, as well as the pattern of antidiabetic treatment, and differences according to gender. MATERIALS AND METHODS: An epidemiological, observational, cross-sectional, nationwide study was conducted in patients of both genders diagnosed with DM2 and established CVD. RESULTS: The study included 3,143 patients with a mean age 69.0±10 years. The mean HbA1c was 7.4±1.1% in females vs 7.3±1.2% in males (P<.05) and systolic blood pressure was 137±15.0mmHg in females vs 135.6±14.7mmHg in males (P<.05). The mean LDL-cholesterol was 101.5±38.1mg/dl in females vs 91.1±37.5mg/dl in males; P<.001) and the mean body mass index (30.7±5.4kg/m2 in females vs 29.6±4.5kg/m2 in males; P<.001). The most used treatments were metformin (68.1%) and/or DPP4 inhibitors (53.7%), with no differences between genders. CONCLUSIONS: The level of blood glucose control of DM2 patients with CVD in Spain can be improved. The treatment profile does not conform to the recommendations of clinical practice guidelines in general. The differences in the control of CVRF are worse in women for lipids and obesity.

[ESCRYTO study. Diabetes without cardiovascular disease and level of control]. / Estudio ESCRYTO. Diabetes sin enfermedad cardiovascular y grado de control.

BACKGROUND AND OBJECTIVES: Diabetes is a significant risk factor for the development of cardiovascular disease, which is the main cause of death. The purpose of this study was to determine the level of glycaemic control in patients with type 2 diabetes without cardiovascular disease in Spain. The data used includes the most recent determination of glycosylated haemoglobin, as well as the pattern of antidiabetic treatment, the incidence of episodes of severe hypoglycaemia in the last 6 months, and the level of control of cardiovascular risk factors, and gender. PATIENTS AND METHODS: A national, multicentre, and cross-sectional epidemiological study in which 800 doctors associated with the GDPS network participated. RESULTS: Of the total of 1,059 patients, 57% male, with a mean age of 62.7 years in men vs. 65.2 in women (P<.001). The mean onset of diabetes was 9.4±7.5 years. The mean HbA1C was 7.0% in men vs. 7.1% in women (P=.039), with the control objective of <7% being observed in 47.2%. There were 65% patients on treatment with metformin, and 62.4% on DPP-4 inhibitors, and basal insulin: 14.2%. Incidence of severe hypoglycemias in the last 6 months was 1.9%. The women had worse glycaemic control, total cholesterol, LDL cholesterol, abdominal obesity, and glomerular filtration levels. CONCLUSIONS: The glycaemic control is worse in women even if adjusted for age and time of onset of diabetes (P=.043), and for the number of hypoglycaemic agents (P=.015). The level of control is also worse in women for dyslipidaemia, abdominal obesity, and glomerular filtration. A preventive strategy promoted from Primary care on healthy lifestyles and controlling all vascular risk factors is essential.

Control glucémico de los pacientes ancianos con diabetes mellitus tipo 2 en España (2015) y su relación con la capacidad funcional y la comorbilidad. Estudio Escadiane / Glycaemic control of elderly patients with type 2 diabetes mellitus in Spain (2015) and its relationship with functional capacity and comorbidity. The Escadiane study

Objetivos. Conocer el estado del control glucémico de los pacientes ancianos con diabetes mellitus tipo 2 en España y su relación con la capacidad funcional y la comorbilidad. Métodos. Estudio transversal, observacional, multicéntrico, de ámbito nacional, en pacientes con diabetes mellitus≥65 años. Se estudiaron variables sociodemográficas, antropométricas, factores de riesgo cardiovascular, datos de exploración clínica y analíticos, comorbilidad asociada y tratamientos utilizados. Se analizó la capacidad funcional mediante el índice de Barthel y la comorbilidad con el de Charlson. Resultados. Se incluyeron 939 pacientes. La edad media fue 76,4±6,7 años. La hemoglobina glucosilada (HbA1c) media fue 7,0±1,2% y la glucemia basal media 137±39,6mg/dl. El nivel de HbA1c presentó diferencias estadísticamente significativas según el grado de discapacidad. En los pacientes con dependencia total, grave, moderada, leve o independientes las concentraciones de HbA1c media fueron de 7,0%, 7,9%, 7,4% y 7,0% (p<0,028) respectivamente. Los niveles de HbA1c fueron de 7,3%, 7,1% y 6,9% en los pacientes con comorbilidad muy alta, alta y media, respectivamente (p<0,001). Conclusiones. Los valores medios de HbA1c en los pacientes ancianos con diabetes tipo 2 analizados en España son inferiores a los recomendados por las principales guías de práctica clínica. Son más elevados en los pacientes que presentan mayor grado de discapacidad funcional y un nivel más alto de comorbilidad (AU)

Objectives. To understand the state of glycaemic control of elderly patients with type 2 diabetes mellitus in Spain and its relationship with functional capacity and comorbidity. Methods. Cross-sectional, observational, multicentre national study on patients with diabetes mellitus aged 65 years or older. The study analysed demographic and anthropometric variables, cardiovascular risk factors, clinical and laboratory data, associated comorbidity and treatments. We analysed the functional capacity using the Barthel index and the comorbidity with Charlson index. Results. The study included 939 patients with a mean age of 76.4±6.7 years. The mean glycated haemoglobin (HbA1c) level was 7.0%±1.2%, and the mean basal blood glucose level was 137±39.6mg/dL. The HbA1c level showed statistically significant differences depending on the degree of disability. In the patients who were totally, severely, moderately or slightly dependent or who were independent, the mean HbA1c levels were 7.0%, 7.9%, 7.4% and 7.0%, respectively (P<.028). HbA1c levels were 7.3%, 7.1% and 6.9% in the patients with very high, high and medium comorbidity, respectively (P<.001). Conclusions. Mean HbA1c levels in elderly patients with type 2 diabetes analysed in Spain are below those recommended by the main clinical practice guidelines. The levels are higher in patients who have more functional disability and a higher level of comorbidity (AU)

Glycaemic control of elderly patients with type 2 diabetes mellitus in Spain (2015) and its relationship with functional capacity and comorbidity. The Escadiane study. / Control glucémico de los pacientes ancianos con diabetes mellitus tipo 2 en España (2015) y su relación con la capacidad funcional y la comorbilidad. Estudio Escadiane.

OBJECTIVES: To understand the state of glycaemic control of elderly patients with type 2 diabetes mellitus in Spain and its relationship with functional capacity and comorbidity. METHODS: Cross-sectional, observational, multicentre national study on patients with diabetes mellitus aged 65 years or older. The study analysed demographic and anthropometric variables, cardiovascular risk factors, clinical and laboratory data, associated comorbidity and treatments. We analysed the functional capacity using the Barthel index and the comorbidity with Charlson index. RESULTS: The study included 939 patients with a mean age of 76.4±6.7 years. The mean glycated haemoglobin (HbA1c) level was 7.0%±1.2%, and the mean basal blood glucose level was 137±39.6mg/dL. The HbA1c level showed statistically significant differences depending on the degree of disability. In the patients who were totally, severely, moderately or slightly dependent or who were independent, the mean HbA1c levels were 7.0%, 7.9%, 7.4% and 7.0%, respectively (P<.028). HbA1c levels were 7.3%, 7.1% and 6.9% in the patients with very high, high and medium comorbidity, respectively (P<.001). CONCLUSIONS: Mean HbA1c levels in elderly patients with type 2 diabetes analysed in Spain are below those recommended by the main clinical practice guidelines. The levels are higher in patients who have more functional disability and a higher level of comorbidity.

Quality of life and fear for hypoglycaemia in patients with type 2 diabetes mellitus. / Calidad de vida y grado de preocupación por las hipoglucemias en pacientes con diabetes mellitus tipo 2.

OBJECTIVES: Hypoglycaemia can negatively impact many aspects of type 2 diabetes mellitus (T2DM) management. The aim was to determine the impact of hypoglycaemia and the fear for hypoglycemic episodes on HRQoL in T2DM patients in Spain, as well as healthcare professionals' attitudes and knowledge of these issues. PATIENTS AND METHODS: An observational, cross-sectional study, with consecutive recruitment of T2DM patients in 661 healthcare centers, between September 2010 and May 2011. Sociodemographic and clinical variables were recorded. HRQoL (ADDQoL questionnaire) and fear for hypoglycaemia (HFS-II) were evaluated. Two groups were compared: with and without reported hypoglycaemia in the previous 6 months. Physicians responded 4 questions (visual analogue scales). RESULTS: 4.054 patients participated, of which 3,812 were selected [mean age (SD)=64 (11) years; male=54%; 10 (7) years for diagnostic of T2DM]. Patients with hypoglycaemia (45%) expressed higher fear for hypoglycemia [31.32 (15.71) vs. 18.85 (16.03); p<0.0001] and the overall impact of T2DM on their HRQoL was more negative [-2.48 (1.61) vs. -1.64 (1.36); p<0.001]. Respondent physicians occasionally used HRQoL questionnaires, knew about hypoglycaemia risk, explored fear for hypoglycaemia and modified treatments accordingly. CONCLUSIONS: T2DM patients with hypoglycaemia show an increase of fear for them, negatively affecting T2DM patients HRQoL. However physicians know the risk of hypoglycaemia, they explore the fear for hypoglycemic episodes occasionally.

[Cost-effectiveness analysis of fixed dose antihypertensive drugs]. / Análisis coste-eficacia de los antihipertensivos en dosis fijas.

OBJECTIVE: The aim of this study is to compare the efficiency of different fixed-dose combinations of renin-angiotensin-aldosterone system (RAAS) blockers and calcium channel blockers, to use it as a guide to assist the rational prescribing in antihypertensive therapy. METHODS: The efficacy of each drug was obtained from intervention studies randomized, double-blind, made with these combinations and a utility-cost modeling from the model proposed and used by NICE. The perspective of our analysis is the National Health System and the time horizon is long enough to achieve therapeutic goals. MAIN OUTCOME MEASURES: Cost per mmHg reduction in BP, percentage of reduction necessary to achieve the therapeutic goals for hypertension control and cost, and finally quantity and quality of life gained with these treatments in patients with hypertension, diabetes. RESULTS: We studied three fixed-dose combinations: amlodipine/olmesartán, amlodipine/valsartan and manidipine/delapril. The cost per mmHg systolic BP ranged from 24.93 to 12.34 €/mmHg, and diastolic BP ranged from 34.24 to 18.76 €/mmHg, depending on the drug used. For an initial value of 165mmHg systolic BP the most efficient treatment to achieve the therapeutic goal of hypertension control (<140mmHg) is manidipine/delapril with a cost of 67.76 €. The use of these drugs to control diabetic and hypertensive patients resulted in all cases being cost-effective (more effective and lower cost compared to "no treatment"). Manidipine/delapril showed the best relation cost-utility (1,970 €/QALY (quality-adjusted life year)) followed by amlodipine/olmesartan and amlodipine/valsartan (2,087 and 2,237 €/QALY, respectively).

Análisis coste-eficacia de los antihipertensivos en dosis fijas / Cost-effectiveness analysis of fixed dose antihypertensive drugs

Objetivo. Comparar la eficiencia de las combinaciones en dosis fijas del bloqueo del SRAA con antagonistas del calcio, para que sirva como guía de ayuda a la prescripción racional del tratamiento antihipertensivo. Metodología. La eficacia de cada uno de los medicamentos ha sido obtenida de los estudios de intervención aleatorizados, doble ciego, realizados con estas combinaciones y una modelización de coste utilidad a partir del modelo propuesto por el NICE. La perspectiva de nuestro análisis es la del Sistema Nacional de Salud y el horizonte temporal ha sido un tiempo suficiente para alcanzar objetivos terapéuticos. Mediciones principales Coste por mmHg de descenso de la PA; porcentaje de descenso necesario para alcanzar los objetivos terapéuticos de control de la HTA y su coste y, finalmente, cantidad y calidad de vida ganada con estos tratamientos en pacientes hipertensos-diabéticos. Resultados. Se estudiaron 3 combinaciones fijas: amlodipino/olmesartán, amlodipino/valsartán y manidipino/delapril. Respecto a la PAS el coste por mmHg de PA reducido osciló entre 24,93 y 12,34€/mmHg, y para la PAD los costes fueron de 34,24 y 18,76 €/mmHg, dependiendo del fármaco empleado. Para una cifra inicial de PAS de 165 mmHg hay 3 opciones terapéuticas que pueden alcanzar la cifra de objetivo terapéutico (< 140 mmHg), siendo la más eficiente manidipino/delapril con 67,76 €. Estos fármacos fueron coste-efectivos respecto al no tratamiento en el control de pacientes hipertensos diabéticos. El medicamento que mostró mejor relación coste-utilidad fue manidipino/delapril (1.970 €/AVAC) seguido de amlodipino/olmesartán y amlodipino/valsartán (2.087 y 2.237 €/AVAC) (AU)

Objective. The aim of this study is to compare the efficiency of different fixed-dose combinations of renin-angiotensin-aldosterone system (RAAS) blockers and calcium channel blockers, to use it as a guide to assist the rational prescribing in antihypertensive therapy. Methods. The efficacy of each drug was obtained from intervention studies randomized, double-blind, made with these combinations and a utility-cost modeling from the model proposed and used by NICE. The perspective of our analysis is the National Health System and the time horizon is long enough to achieve therapeutic goals. Main outcome measures. Cost per mmHg reduction in BP, percentage of reduction necessary to achieve the therapeutic goals for hypertension control and cost, and finally quantity and quality of life gained with these treatments in patients with hypertension, diabetes. Results. We studied three fixed-dose combinations: amlodipine/olmesartán, amlodipine/valsartan and manidipine/delapril. The cost per mmHg systolic BP ranged from 24.93 to 12.34 €/mmHg, and diastolic BP ranged from 34.24 to 18.76 €/mmHg, depending on the drug used. For an initial value of 165 mmHg systolic BP the most efficient treatment to achieve the therapeutic goal of hypertension control (< 140 mmHg) is manidipine/delapril with a cost of 67.76 €. The use of these drugs to control diabetic and hypertensive patients resulted in all cases being cost-effective (more effective and lower cost compared to "no treatment"). Manidipine/delapril showed the best relation cost-utility (1,970 €/QALY (quality-adjusted life year)) followed by amlodipine/olmesartan and amlodipine/valsartan (2,087 and 2,237 €/QALY, respectively) (AU)