Efectos a largo plazo de una intervención intensiva sobre cambios en los estilos de vida en pacientes con hiperfibrinogenemia y riesgo cardiovascular moderado-alto / Long-term effects of intensive intervention on changes in lifestyle in patients with hyperfibrinogenaemia and moderate-high cardiovascular risk

OBJETIVOS: Evaluar si persiste el beneficio sobre los factores de riesgo cardiovascular (FRCV) a los 5 años de una intervención intensiva en estilos de vida (EV) que duró 2 años, en pacientes con hiperfibrinogenemia y riesgo cardiovascular moderado o alto. DISEÑO: Estudio observacional prospectivo multicéntrico. Emplazamiento: Trece Centros de Atención Primaria de Barcelona y Baix Llobregat. PARTICIPANTES: Un total de 300 pacientes que finalizaron el estudio EFAP (146 del grupo intervención y 154 del control). INTERVENCIONES: El estudio EFAP, realizado con pacientes con cifras de colesterol normal y fibrinógeno elevado, mostró que las intervenciones sobre el estilo de vida son eficaces en la reducción de FRCV. Finalizado el estudio EFAP, los 2 grupos siguieron los controles habituales. Pasados 5 años evaluamos los 2 grupos. Mediciones principales: Edad, sexo, FRCV (diabetes, dislipidemia, hipertensión arterial, obesidad), analítica (fibrinógeno, glucosa, hemograma, colesterol, triglicéridos), presión arterial, peso, talla, índice de masa corporal (IMC), hábitos tóxicos (tabaco y alcohol), REGICOR. RESULTADOS: A los 5 años, el grupo intervención presentó respecto al control menor perímetro abdominal (98 y 101 cm, respectivamente; p = 0,043), menor peso (76,30 y 75,04kg, respectivamente; p < 0,001) e IMC (29,5 y 30, 97 kg/m2; p = 0,018). El nivel de fibrinógeno fue inferior en el grupo intervención (330,33 y 320,27 mg/dl respectivamente; p < 0,001), y riesgo REGICOR también fue inferior en el grupo intervención (5,65 y 5,59 respectivamente; p < 0,06). CONCLUSIÓN: El beneficio de una intervención intensiva en EV durante 2 años para reducir los FRCV persiste a los 5 años, pero disminuye su intensidad con el tiempo. Se recomienda repetir periódicamente las intervenciones para mantener el efecto beneficioso sobre los EV

OBJECTIVES: To determine whether the benefit on cardiovascular risk factors (CVRF) persists 5 years after an intensive intervention in lifestyle (LS) that lasted 2 years, in patients with hyperfibrinogenaemia and moderate or high cardiovascular risk. DESIGN: multicentre prospective observational study. LOCATION: 13 Primary Care Centres in Barcelona and Baix Llobregat. PARTICIPANTS: A total of 300 patients who completed the EFAP study (146 intervention group, 154 control group). INTERVENTIONS: The EFAP study, conducted on patients with normal cholesterol and elevated fibrinogen showed that lifestyle interventions are effective in reducing CVRF. After the EFAP study, the 2 groups followed the usual controls, and re-assessed after 5 years. MAIN MEASUREMENTS: Age, gender, cardiovascular diseases (CVD) (diabetes, dyslipidaemia, hypertension, obesity), laboratory parameters (fibrinogen, glucose, full blood count, cholesterol, triglycerides), blood pressure, weight, height, body mass index (BMI), tobacco and alcohol use, REGICOR. RESULTS: At 5 years, the intervention group had a lower abdominal circumference (98 and 101cm, respectively, P = .043), a lower weight (76.30 and 75.04 kg, respectively, P < .001), and BMI (29.5 and 30.97 kg/m2, P = .018). Fibrinogen level was lower in the intervention group (330.33 and 320.27 mg/dl respectively, P < .001), and REGICOR risk was also lower in the intervention group (5.65 and 5.59 respectively, P < .06). CONCLUSION: The benefit of an intensive intervention in LS for 2 years to reduce CVRF persists at 5 years, but decreases its intensity over time. It is recommended to repeat the interventions periodically to maintain the beneficial effect on LS

[Long-term effects of intensive intervention on changes in lifestyle in patients with hyperfibrinogenaemia and moderate-high cardiovascular risk]. / Efectos a largo plazo de una intervención intensiva sobre cambios en los estilos de vida en pacientes con hiperfibrinogenemia y riesgo cardiovascular moderado-alto.

OBJECTIVES: To determine whether the benefit on cardiovascular risk factors (CVRF) persists 5 years after an intensive intervention in lifestyle (LS) that lasted 2 years, in patients with hyperfibrinogenaemia and moderate or high cardiovascular risk. DESIGN: multicentre prospective observational study. LOCATION: 13 Primary Care Centres in Barcelona and Baix Llobregat. PARTICIPANTS: A total of 300 patients who completed the EFAP study (146 intervention group, 154 control group). INTERVENTIONS: The EFAP study, conducted on patients with normal cholesterol and elevated fibrinogen showed that lifestyle interventions are effective in reducing CVRF. After the EFAP study, the 2 groups followed the usual controls, and re-assessed after 5 years. MAIN MEASUREMENTS: Age, gender, cardiovascular diseases (CVD) (diabetes, dyslipidaemia, hypertension, obesity), laboratory parameters (fibrinogen, glucose, full blood count, cholesterol, triglycerides), blood pressure, weight, height, body mass index (BMI), tobacco and alcohol use, REGICOR. RESULTS: At 5 years, the intervention group had a lower abdominal circumference (98 and 101cm, respectively, P=.043), a lower weight (76.30 and 75.04kg, respectively, P<.001), and BMI (29.5 and 30.97kg/m2, P=.018). Fibrinogen level was lower in the intervention group (330.33 and 320.27 mg/dl respectively, P < .001), and REGICOR risk was also lower in the intervention group (5.65 and 5.59 respectively, P < .06). CONCLUSION: The benefit of an intensive intervention in LS for 2 years to reduce CVRF persists at 5 years, but decreases its intensity over time. It is recommended to repeat the interventions periodically to maintain the beneficial effect on LS.

Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial.

BACKGROUND: Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity. METHODS: Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up. RESULTS: Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio. CONCLUSIONS: The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.

Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease.

BACKGROUND: We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD) and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids. RESULTS: This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA) in l'Hospitalet de Llobregat (Barcelona) and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl), cholesterol < 250 mg/dl, 218 of whom received a more intensive intervention consisting of advice on lifestyle and treatment. The follow-up frequency of the intervention group was every 2 months. The other 218 patients followed their standard care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index. CONCLUSION: Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01089530.

Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area.

BACKGROUND: The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study to determine whether a group motivational intervention, together with current clinical practice, is more efficient than the latter alone in the treatment of overweight and obesity, for initial weight loss and essentially to achieve maintenance of the weight achieved; and, secondly, to know if this intervention is more effective for reducing cardiovascular risk factors associated with overweight and obesity. METHODS: This 26-month follow up multi-centre trial, will include 1200 overweight/obese patients. Random assignment of the intervention by Basic Health Areas (BHA): two geographically separate groups have been created, one of which receives group motivational intervention (group intervention), delivered by a nurse trained by an expert phsychologist, in 32 group sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard program of diet, exercise, and the other (control group), receiving the usual follow up, with regular visits every 3 months. DISCUSSION: By addressing currently unanswered questions regarding the maintenance in weight loss in obesity/overweight, upon the expected completion of participant follow-up in 2012, the IMOAP trial should document, for the first time, the benefits of a motivational intervention as a treatment tool of weight loss in a primary care setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01006213.

Ensayo clínico de intervención en pacientes con hiperfibrinogenemia en prevención primaria de enfermedad cardiovascular en el ámbito de la atención primaria de salud / Clinical intervention study in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease

Objetivos. Estudiar el posible efecto de un programa intensivo de modificación del estilo de vida en los valores de fibrinógeno plasmático en pacientes sin enfermedad cardiovascular, con fibrinógeno elevado y valores normales de colesterol y riesgo cardiovascular (RCV) moderado. Analizar si el efecto en el fibrinógeno es independiente o no del efecto en los lípidos. Métodos. Ensayo clínico controlado y aleatorizado. Se incluyeron 13 Áreas Básicas de Salud (ABS) de L'Hospitalet de Llobregat (Barcelona) y Barcelona ciudad. Participaron 436 pacientes de 35-75 años, sin enfermedad cardiovascular, con hiperfibrinogenemia (fibrinógeno > 300 mg/dl) y colesterol plasmático < 250 mg/dl, de los cuales 218 recibieron una intervención intensiva, en frecuencia e intensidad, del consejo sobre cambios de estilo de vida y tratamiento. El seguimiento del grupo de intervención fue cada 2 meses. Otros 218 pacientes siguieron los cuidados habituales de las ABS. Se valoraron los parámetros siguientes: fibrinógeno, colesterol plasmático y otros de bioquímica clínica. Resultados. La evaluación de las características basales de los pacientes mostró que ambos grupos son homogéneos. La obesidad y la hipertensión fueron los factores de riesgo más prevalentes. A los 24 meses del estudio, se encontraron modificaciones estadísticamente significativas, entre las medias ajustadas de los 2 grupos para los parámetros siguientes: fibrinógeno, colesterol plasmático, presiones arteriales sistólica y diastólica e índice de masa corporal. Conclusión. La intervención intensiva, para lograr cambios de estilo de vida, se ha mostrado eficaz en la reducción de algunos factores de RCV. El efecto de la intervención intensiva en los valores plasmáticos del fibrinógeno no guarda correlación con las variaciones del colesterol (AU)

Objectives. To study the possible effects of an intensive lifestyle change program on the plasma fibrinogen levels in patients with no cardiovascular disease, with a high fibrinogen and normal cholesterol levels, and moderate cardiovascular risk (CVR). To analyse whether or not the effect on fibrinogen is independent of the effect on lipids. Methods. Controlled, randomised clinical trial in 13 basic health areas (BHA) in L'Hospitalet de Llobregat (Barcelona) and Barcelona city. Of the 436 patients between 35 and 75 years with no cardiovascular disease, with a high plasma fibrinogen (> 300 mg/dl) and a plasma cholesterol < 250 mg/dl, 218 received a more frequent and intensive intervention, of advice on lifestyle changes and treatment. The follow up frequency of the intervention group was every 2 months. The other 218 patients continued with their usual care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed. Results. The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. At 24 months of the study, statistically changes were found between the adjusted means of the twos groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index. Conclusion. Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some cardiovascular risk factors. The effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol (AU)