Sustained-release isosorbide mononitrate as adjuvant treatment in isolated systolic hypertension in the elderly.

Hypertension is one of the main cardiovascular risk factors. In the elderly, the most common form is isolated systolic hypertension, a consequence of the increase in arterial stiffness. None of the antihypertensives currently used affects arterial stiffness, whereas nitrates seem to have an effect. The aim of this work was to assess their effect on elderly patients with uncontrolled isolated systolic hypertension, defined as systolic blood pressure over 140 mmHg and diastolic blood pressure under 90 mmHg. The present study is a phase III, randomized, multicenter, double-blind, placebo-controlled clinical trial, conducted at the University Hospital La Princesa in Madrid. Patients of both sexes, aged 65 years or older, with poorly controlled isolated systolic hypertension, were treated with 40-60 mg of sustained-release isosorbide mononitrate or matching placebo for 12 weeks. The main objective was to assess the effect on clinical pulse pressure (PP); in addition, its effect on vascular function was evaluated. Analysis was performed by intention to treat. The study was registered at the European Union Clinical Trials Register (EUDRACT 2012-002988-10) and was funded by the Spanish Ministry of Health. A total of 58 patients with an average age of 77 years were enrolled, 32 were treated with nitrate, and 26 with placebo. No significant differences were found either in PP decline (5.28 vs 7.49 mmHg, p = 0.79) or in other variables, including parameters of vascular function. There were no differences in adverse events. The results of this study have not confirmed the benefit of nitrate treatment in isolated systolic hypertension or the improvement of vascular function.

Ambulatory Blood Pressure Monitoring in HIV-Infected Patients: Usefulness for Cardiovascular Risk Assessment.

BACKGROUND: There is a lack of consensus regarding the risk of hypertension in HIV-infected patients compared to the general population. Ambulatory blood pressure monitoring (ABPM) is the most accurate method for the hypertension diagnosis. Nevertheless, it is rarely used in HIV clinical care. MATERIALS AND METHODS: All HIV-infected patients who underwent 24 hours ABPM were included. The agreement between office blood pressure (BP) readings and ABPM was analyzed. The rate of patients with masked hypertension (MH), isolated clinical hypertension, and nocturnal hypertension was obtained. Furthermore, it was analyzed if the differences between both methods may affect the cardiovascular risk (CVR) assessment. RESULTS: A total of 116 patients were included. The κ coefficient between office BP and ABPM was 0.248. Over a quarter of the cohort was diagnosed with MH-25.8% (CI 95% 17.7%-34.0%), and 12% (CI 95%: 6.1%-16.1%) was diagnosed with ICH. Moreover, 19% of patients had hypertension exclusively during the night. The patients classified as low risk according to the CVR scores had a different diagnosis with ABPM than with office BP (P < .001). CONCLUSIONS: The agreement between office BP and ABPM was low in HIV-infected patients. Ambulatory BP monitoring is useful in HIV-infected patients as a hypertension diagnosis method, especially among patients classified as low risk.

[Cardiovascular morbimortality reduction after an acute cardiovascular event through multifactorial and intensive cardiovascular risk factors management (MIRVAS project)]. / Reducción de la morbimortalidad cardiovascular tras un episodio cardiovascular agudo mediante el tratamiento intensivo de los factores de riesgo (proyecto MIRVAS).

BACKGROUND AND OBJECTIVE: In spite of publication of many guidelines, management of patients on secondary prevention of cardiovascular disease is still not appropriated. We design a randomized trial, in usual clinical practice conditions, to compare the results in cardiovascular morbimortality of intensive and integral management of cardiovascular risk factors (CVRF) management versus conventional care. PATIENTS AND METHOD: We selected patients discharged between October 2002 and January 2004 who suffered an acute coronary syndrome with or without ST-segment elevation or a stroke, 247 patients that met inclusions criteria were randomized to intensive care of CVRF in a specific Internal Medicine outpatient clinic (n = 121) or usual care according to National Health Service recommendations (n = 126). A year after randomization, the percentage of patients who met CVRF control, treatment received and the number of cardiovascular events (cardiovascular death, acute coronary syndrome with or without ST-segment elevation, stroke, transient ischemic attack, revascularization, lower limb amputation, heart failure admission and sudden death) were revised. RESULTS: CVRF control was greater in patients assigned to intensive care. 74.1% of hypertensive patients assigned to this treatment were controlled vs 41.7% in the usual care group (relative risk [RR] = 1.78; 95% confidence interval [CI], 1.27-2-49); 70.2% of patients had low-densi-tiy lipoprotein cholesterol lower than 100 mg/dl vs 55.8% (RR = 1.26; 95% CI, 1.00-1.58) of patients in usual care group; 93.1% of diabetic patients had glycosylated haemoglobin lower than 7% vs. 57.1% (RR = 1.63; 95% CI, 1.11-2.39) in the usual care group. There were 12 cardiovascular events in the intensive care group vs 35 in the usual care group. CONCLUSIONS: Intensive management of CVRF leads to a better control of them and a reduction of the morbimortality one year after an acute cardiovascular event.

Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS Study.

INTRODUCTION AND OBJECTIVES: The aim was to determine whether secondary prevention involving the comprehensive and intensive treatment of cardiovascular risk factors reduces cardiovascular events and cardiovascular mortality at 3-year follow up. METHODS: The study design comprised a randomized, controlled, open trial in a routine clinical practice setting. In total, 247 patients who presented with acute coronary syndrome or stroke were selected. They were randomized to comprehensive and intensive treatment of cardiovascular risk factors (n=121) or to follow-up based on usual care (n=126). The main study outcomes were the number of cardiovascular events and cardiovascular mortality at 3-year follow-up. The percentage of patients in whom each risk factor was successfully controlled was a secondary outcome. RESULTS: Overall, 88.8% of patients assigned to the intensive treatment group had a low-density lipoprotein cholesterol level <100mg/dl compared with 56.4% of the usual-care group (relative risk [RR]=1.57; 95% confidence interval [CI], 1.28-1.93), and 75.7% of diabetics had a hemoglobin A(1c) <7% compared with 28.6% of the usual-care group (RR=2.65; 95% CI, 1.13-6.19). There were four deaths due to cardiovascular causes and 26 nonfatal events in the intensive treatment group versus 17 deaths and 54 nonfatal events in the usual-care group. The cumulative survival rate at 3 years was 97.4% in the intervention group and 85.5% in the control group (p=.003). CONCLUSIONS: Secondary prevention involving comprehensive and intensive treatment of cardiovascular risk factors reduced both morbidity and mortality at 3-year follow up.

Impacto de un tratamiento integral e intensivo de factores de riesgo sobre la mortalidad cardiovascular en prevención secundaria: estudio MIRVAS / Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS study

Introducción y objetivos. Evaluamos si un tratamiento integral e intensivo de factores de riesgo cardiovascular logra reducir el número de eventos cardiovasculares y la tasa de mortalidad cardiovascular en pacientes en prevención secundaria a 3 años de seguimiento. Métodos. Se diseñó un ensayo clínico aleatorizado, controlado, no enmascarado y en condiciones de práctica clínica. Se seleccionó a 247 pacientes que habían tenido un síndrome coronario agudo o un ictus y se los aleatorizó a un tratamiento integral e intensivo de los factores de riesgo cardiovascular (n=121) o al seguimiento según la práctica clínica habitual (n=126). Las variables principales fueron: el número de episodios cardiovasculares ocurridos y la mortalidad cardiovascular tras 3 años de seguimiento. La variable secundaria fue el porcentaje de pacientes que alcanzaban control de cada factor de riesgo. Resultados. El 88,8% de los pacientes asignados al grupo de tratamiento intensivo tenía las lipoproteínas de baja densidad en < 100 mg/dl frente al 56,4% (riesgo relativo [RR]=1,57; intervalo de confianza [IC]del 95%, 1,28-1,93) del grupo de tratamiento habitual; un 75,7% de los diabéticos tenían valores de HbA1c < 7% frente a un 28,6% (RR=2,65; IC del 95%, 1,13-6,19) del grupo de tratamiento habitual. Ocurrieron 4 muertes de causa cardiovascular y 26 eventos no mortales en el grupo de tratamiento intensivo frente a 17 muertes y 54 eventos no mortales en el grupo de tratamiento habitual. La tasa de supervivencia a 3 años fue del 97,4% en el grupo intervención y el 85,5% en el grupo control (p=0,003). Conclusiones. Un tratamiento integral e intensivo de los factores de riesgo cardiovascular en pacientes en prevención secundaria reduce la morbimortalidad tras 3 años de seguimiento(AU)

The aim was to determine whether secondary prevention involving the comprehensive and intensive treatment of cardiovascular risk factors reduces cardiovascular events and cardiovascular mortality at 3-year follow up. Methods: The study design comprised a randomized, controlled, open trial in a routine clinical practice setting. In total, 247 patients who presented with acute coronary syndrome or stroke were selected. They were randomized to comprehensive and intensive treatment of cardiovascular risk factors (n=121) or to follow-up based on usual care (n=126). The main study outcomes were the number of cardiovascular events and cardiovascular mortality at 3-year follow-up. The percentage of patients in whom each risk factor was successfully controlled was a secondary outcome. Results: Overall, 88.8% of patients assigned to the intensive treatment group had a low-density lipoprotein cholesterol level <100 mg/dl compared with 56.4% of the usual-care group (relative risk [RR]=1.57; 95% confidence interval [CI], 1.28-1.93), and 75.7% of diabetics had a hemoglobin A1c <7% compared with 28.6% of the usual-care group (RR=2.65; 95% CI, 1.13-6.19). There were four deaths due to cardiovascular causes and 26 nonfatal events in the intensive treatment group versus 17 deaths and 54 nonfatal events in the usual-care group. The cumulative survival rate at 3 years was 97.4% in the intervention group and 85.5% in the control group (p=.003). Conclusions: Secondary prevention involving comprehensive and intensive treatment of cardiovascular risk factors reduced both morbidity and mortality at 3-year follow up(AU)

Reducción de la morbimortalidad cardiovascular tras un episodio cardiovascular agudo mediante el tratamiento intensivo de los factores de riesgo (proyecto MIRVAS) / Cardiovascular morbimortality reduction after an acute cardiovascular event through multifactorial and intensive cardiovascular risk factors management (MIRVAS project)

Fundamento y objetivo: A pesar de la publicación de numerosas guías de tratamiento, el seguimiento de los pacientes en prevención secundaria de enfermedad cardiovascular todavía no es el adecuado. Hemos diseñado un ensayo aleatorizado en situación de práctica clínica habitual para evaluar los resultados de un programa de tratamiento integral e intensivo de los factores de riesgo cardiovascular (FRCV) frente al tratamiento convencional en la morbimortalidad cardiovascular. Pacientes y método: Entre octubre de 2002 y enero de 2004 se seleccionó a todos los pacientes dados de alta que habían presentado un síndrome coronario agudo, con o sin elevación del segmento ST, o un ictus. Cumplían los criterios de inclusión un total de 247, que se asignaron aleatoriamente a un tratamiento integral e intensivo de los FRCV en una consulta monográfica atendida por un médico internista (n = 121) o al seguimiento habitual según las recomendaciones del Sistema Nacional de Salud (n = 126). Un año después de la inclusión se comprobó el porcentaje de pacientes que habían alcanzado el control óptimo de cada factor de riesgo, así como el tratamiento recibido y el número de episodios cardiovasculares sucesivos (muerte por causa cardiovascular, síndrome coronario agudo con o sin elevación del segmento ST, ictus, accidente isquémico transitorio, revascularización en cualquier territorio, amputación de extremidades inferiores, ingreso por insuficiencia cardíaca y muerte súbita). Resultados: El control de los FRCV fue superior en el grupo de tratamiento intensivo. Un 74,1% de los pacientes hipertensos asignados a este tratamiento estaban controlados, frente al 41,7% del grupo de tratamiento habitual (riesgo relativo [RR] = 1,78; intervalo de confianza [IC] del 95%, 1,27-2,49); un 70,2% presentaba cifras de colesterol unido a lipoproteínas de baja densidad menores de 100 mg/dl, frente a un 55,8% (RR = 1,26; IC del 95%, 1,00-1,58) del grupo de tratamiento habitual; un 93,1% de los diabéticos presentaba valores de hemoglobina glucosilada inferiores al 7%, frente a un 57,1% (RR = 1,63; IC del 95%, 1,11-2,39) del grupo de tratamiento habitual. Se produjeron 12 episodios cardiovasculares en el grupo de intervención, frente a 35 en el grupo de tratamiento habitual. Conclusiones: El tratamiento intensivo aumenta la proporción de pacientes que alcanzan un control óptimo de los FRCV y reduce la morbimortalidad durante el año siguiente a un episodio cardiovascular

Background and objective: In spite of publication of many guidelines, management of patients on secondary prevention of cardiovascular disease is still not appropriated. We design a randomized trial, in usual clinical practice conditions, to compare the results in cardiovascular morbimortality of intensive and integral management of cardiovascular risk factors (CVRF) management versus conventional care. Patients and method: We selected patients discharged between October 2002 and January 2004 who suffered an acute coronary syndrome with or without ST-segment elevation or a stroke, 247 patients that met inclusions criteria were randomized to intensive care of CVRF in a specific Internal Medicine outpatient clinic (n = 121) or usual care according to National Health Service recommendations (n = 126). A year after randomization, the percentage of patients who met CVRF control, treatment received and the number of cardiovascular events (cardiovascular death, acute coronary syndrome with or without ST-segment elevation, stroke, transient ischemic attack, revascularization, lower limb amputation, heart failure admission and sudden death) were revised. Results: CVRF control was greater in patients assigned to intensive care. 74.1% of hypertensive patients assigned to this treatment were controlled vs 41.7% in the usual care group (relative risk [RR] = 1.78; 95% confidence interval [CI], 1.27-2-49); 70.2% of patients had low-densitiy lipoprotein cholesterol lower than 100 mg/dl vs 55.8% (RR = 1.26; 95% CI, 1.00-1.58) of patients in usual care group; 93.1% of diabetic patients had glycosylated haemoglobin lower than 7% vs. 57.1% (RR = 1.63; 95% CI, 1.11-2.39) in the usual care group. There were 12 cardiovascular events in the intensive care group vs 35 in the usual care group. Conclusions: Intensive management of CVRF leads to a better control of them and a reduction of the morbimortality one year after an acute cardiovascular event