Effectiveness of a combined strategy to improve therapeutic compliance and degree of control among patients with hypercholesterolaemia: a randomised clinical trial.

BACKGROUND: In subjects with hypercholesterolaemia, cholesterol values remain above guideline levels. One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence. The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients, consisting of a combined strategy that would include the delivery of printed information, treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner's practice. METHODS/DESIGN: A randomised, parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain's Autonomous Regions (Comunidades Autónomas), covering a total of 358 subjects aged 18 years or over with diagnosis of hypercholesterolaemia. Patients in the intervention group will be supplied with printed material with information on the disease and its management, mobile-telephone text messages with guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance, and self-report cards to check compliance with recommendations. Both groups -intervention and control- will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the measurements to be made, the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of 24 months. The secondary variables are as follows: adherence to recommendations on lifestyle and adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels; appearance of cardiovascular events; physical activity; food consumption; smoking habit; anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents; socio-demographic data; beliefs and expectations about preventive recommendations; and degree of satisfaction with the combined strategy. DISCUSSION: Should this intervention prove effective, a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia. It is a simple, relatively inexpensive intervention. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02314663.

Management of atherogenic dyslipidemia in the primary care setting in Spain.

AIM: To describe the management of atherogenic dyslipidemia (AD) in routine clinical practice in the Primary Care (PC) setting in Spain. METHODS: Observational, descriptive, cross-sectional study based on a structured questionnaire designed for this study and addressed to PC physicians. The questionnaire content was based on a literature review and was validated by 3 experts in AD. RESULTS: A total of 1029 PC physicians participated in the study. 96.99% indicated that AD is determinant for cardiovascular risk, even if LDL-C levels are appropriate. 88.43% evaluated residual cardiovascular risk in their clinical practice, however, only 27.89% of them evaluated it in secondary prevention. Regarding diagnosis, 82.22% reported that TC, TG, HDL-C and non-HDL-C are essential measures when evaluating AD. Almost all physicians reported that they can request fractionated cholesterol to assess HDL-C and LDL-C, however 3.69% could not. Physicians (95.63%) considered that the first step in AD treatment should be diet, regular exercise, smoking cessation and pharmaceutical treatment, if necessary. 19.1% agreed partially or completely that gemfibrozil is the most suitable fibrate to associate with statins. 74.83% completely agreed that fenofibrate is the most suitable fibrate to combine with statins. CONCLUSIONS: Physicians have access to general Spanish guidelines and recommendations associated with AD management, however, it is necessary to continue rising awareness about the importance of early detection and optimal control of AD to reduce patients' cardiovascular risk.

Efficacy of a Combined Strategy to Improve Low-density Lipoprotein Cholesterol Control Among Patients With Hypercholesterolemia: A Randomized Clinical Trial.

INTRODUCTION AND OBJECTIVES: Several interventions can improve low-density lipoprotein cholesterol (LDL-C) control. Our main objective was to evaluate the efficacy of a combined intervention to improve LDL-C control in patients with hypercholesterolemia. The study also assessed the efficacy of the intervention in improving adherence (pharmacological, diet, and exercise). METHODS: A multicenter, parallel group, randomized clinical trial (primary care) was conducted in 358 adults diagnosed with hypercholesterolemia, whether receiving prior drug therapy or not. We compared 178 participants who received the combined intervention (written material, self-completed registration cards, and messages to mobile telephones) with 178 controls. The main outcome variable was the proportion of participants with adequate LDL-C control (target levels of the European guidelines on dyslipidemia and cardiovascular risk) at 24 months. RESULTS: At 24 months, the mean reduction in LDL-C was significantly higher in the intervention group (23.8mg/dL [95%CI, 17.5-30.1]) than in the control group (14.6mg/dL [95%CI, 8.9-20.4]; P=.034). The mean LDL-C decrease was 13.1%±28.6%. At 1 year, the proportion of participants with adequate control was significantly higher in the intervention group than in the control group (43.7% vs 30.1%; P=.011; RR, 1.46). Adherence was significantly higher in the intervention group, both to drug therapy (77.2% vs 64.1%; P=.029) and exercise (64.9% vs 35.8; P<.001), but not to diet. CONCLUSIONS: The combined intervention significantly reduced LDL-C (by more than 13% at 2 years) and improved the degree of LDL-C control in patients with hypercholesterolemia at 1 year.

Eficacia de una estrategia combinada para mejorar el control del colesterol unido a lipoproteínas de baja densidad en pacientes con hipercolesterolemia. Ensayo clínico aleatorizado / Efficacy of a combined strategy to improve low-density lipoprotein cholesterol control among patients with hypercholesterolemia: a randomized clinical trial

Introducción y objetivos: Intervenciones diferentes pueden mejorar el control del colesterol unido a lipoproteínas de baja densidad (cLDL). El objetivo principal era evaluar la eficacia de una intervención combinada para mejorar el control del cLDL de pacientes con hipercolesterolemia. También se evaluó su eficacia para mejorar el cumplimiento (farmacológico, dieta y ejercicio). Métodos: Ensayo clínico aleatorizado, de grupos paralelos y multicéntrico (atención primaria) que incluyó a 358 adultos diagnosticados de hipercolesterolemia con tratamiento previo farmacológico o no. Se comparó a 178 sujetos que recibieron intervención combinada (material escrito, tarjetas autocumplimentadas y mensajes al móvil) frente a 178 controles. La variable principal de resultado fue la proporción de sujetos con adecuado control del cLDL (valores recomendados en las guías europeas de dislipemias y riesgo cardiovascular) a los 24 meses. Resultados: El grupo de intervención mostró una reducción media del cLDL significativamente superior a los 24 meses respecto al control, 23,8 mg/dl (IC95%, 17,5-30,1) y 14,6 mg/dl (IC95%, 8,9-20,4), respectivamente (p = 0,034). El promedio de la reducción del cLDL fue del 13,1 ± 28,6%. La proporción de sujetos con adecuado control al año fue significativamente superior en el grupo de intervención (43,7 frente a 30,1%; p = 0,011; RR = 1,46). En el grupo de intervención, el cumplimiento farmacológico fue significativamente superior (77,2 frente a 64,1%; p = 0,029) y de la práctica de ejercicio (64,9 frente a 35,8%; p < 0,001), aunque no de la dieta. Conclusiones: La intervención combinada consigue una reducción significativa de las cifras de cLDL (superior al 13% al cabo de 2 años) y mejora el grado de control de pacientes con hipercolesterolemia al año (AU)

Introduction and objectives: Several interventions can improve low-density lipoprotein cholesterol (LDL-C) control. Our main objective was to evaluate the efficacy of a combined intervention to improve LDL-C control in patients with hypercholesterolemia. The study also assessed the efficacy of the intervention in improving adherence (pharmacological, diet, and exercise). Methods: A multicenter, parallel group, randomized clinical trial (primary care) was conducted in 358 adults diagnosed with hypercholesterolemia, whether receiving prior drug therapy or not. We compared 178 participants who received the combined intervention (written material, self-completed registration cards, and messages to mobile telephones) with 178 controls. The main outcome variable was the proportion of participants with adequate LDL-C control (target levels of the European guidelines on dyslipidemia and cardiovascular risk) at 24 months. Results: At 24 months, the mean reduction in LDL-C was significantly higher in the intervention group (23.8 mg/dL [95%CI, 17.5-30.1]) than in the control group (14.6 mg/dL [95%CI, 8.9-20.4]; P = .034). The mean LDL-C decrease was 13.1% ± 28.6%. At 1 year, the proportion of participants with adequate control was significantly higher in the intervention group than in the control group (43.7% vs 30.1%; P = .011; RR, 1.46). Adherence was significantly higher in the intervention group, both to drug therapy (77.2% vs 64.1%; P = .029) and exercise (64.9% vs 35.8; P < .001), but not to diet. Conclusions: The combined intervention significantly reduced LDL-C (by more than 13% at 2 years) and improved the degree of LDL-C control in patients with hypercholesterolemia at 1 year (AU)

Management of atherogenic dyslipidemia in the primary care setting in Spain / Manejo de la dislipemia aterogénica en el ámbito de Atención Primaria en España

Aim: To describe the management of atherogenic dyslipidemia (AD) in routine clinical practice in the Primary Care (PC) setting in Spain. Methods: Observational, descriptive, cross-sectional study based on a structured questionnaire designed for this study and addressed to PC physicians. The questionnaire content was based on a literature review and was validated by 3 experts in AD. Results: A total of 1029 PC physicians participated in the study. 96.99% indicated that AD is determinant for cardiovascular risk, even if LDL-C levels are appropriate. 88.43% evaluated residual cardiovascular risk in their clinical practice, however, only 27.89% of them evaluated it in secondary prevention. Regarding diagnosis, 82.22% reported that TC, TG, HDL-C and non-HDL-C are essential measures when evaluating AD. Almost all physicians reported that they can request fractionated cholesterol to assess HDL-C and LDL-C, however 3.69% could not. Physicians (95.63%) considered that the first step in AD treatment should be diet, regular exercise, smoking cessation and pharmaceutical treatment, if necessary. 19.1% agreed partially or completely that gemfibrozil is the most suitable fibrate to associate with statins. 74.83% completely agreed that fenofibrate is the most suitable fibrate to combine with statins. Conclusions: Physicians have access to general Spanish guidelines and recommendations associated with AD management, however, it is necessary to continue rising awareness about the importance of early detection and optimal control of AD to reduce patients' cardiovascular risk

Objetivo: Describir el manejo de la dislipemia aterogénica (DA) en la práctica clínica, en el ámbito de la atención primaria (AP) en España. Métodos: Estudio observacional, descriptivo y transversal, por medio de un cuestionario ad-hoc estructurado, dirigido a médicos de AP. El contenido del cuestionario se basó en una revisión de la literatura y fue validado por 3 expertos en DA. Resultados: Participaron en el estudio 1.029 médicos de AP. El 96,99% coincidió en que la DA constituye un factor determinante del riesgo cardiovascular aunque los niveles de cLDL sean adecuados. Un 88,43% indicó que evaluaba el riesgo residual cardiovascular en su práctica clínica habitual, aunque un 27,89% lo evaluaba solo en prevención secundaria. Un 82,22% consideró que para la valoración de un paciente con DA es imprescindible conocer el colesterol total, los triglicéridos, el cHDL, el cLDL y el no-cHDL. La mayoría indicó que podía solicitar fraccionamiento del colesterol total para valorar el cHDL y el cLDL, de forma rutinaria sin restricciones, pero el 3,69% indicó que no. Un 95,63% consideró que el primer paso en el tratamiento implica un control de la dieta, ejercicio físico, abandono del tabaco y si se precisa, tratamiento farmacológico. Un 19,1% estaba parcial o completamente de acuerdo en que el gemfibrozilo es el fibrato más adecuado para asociar con estatinas. El 74,83% estaba completamente de acuerdo en que el fenofibrato es el fibrato más apropiado para combinar con estatinas. Conclusiones: Los médicos tienen acceso a las guías y recomendaciones clínicas sobre el manejo de la DA, pero es necesario continuar concienciando de la importancia de su detección precoz y control óptimo para limitar su riesgo cardiovascular

Valoración subjetiva de los factores de riesgo de osteoporosis frente a su registro objetivo mediante la herramienta FRAX. Avance del estudio VALSUFRAX / Assessment of subjetive risk factors for osteoporosis in front of objetive registration by FRAX tool. VALSUFRAX study preview

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