ABSTRACT
Importance: Patient empowerment through pharmacologic self-management is a common strategy for some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure (BP). Several trials have shown its potential for reducing BP in the short term, but evidence in the longer term is scarce. Objective: To evaluate the longer-term effectiveness of BP self-monitoring plus self-titration of antihypertensive medication vs usual care for patients with poorly controlled hypertension, with passive follow-up and primary-care nursing involvement. Design, Setting, and Participants: The ADAMPA (Impact of Self-Monitoring of Blood Pressure and Self-Titration of Medication in the Control of Hypertension) study was a randomized, unblinded clinical trial with 2 parallel arms conducted in Valencia, Spain. Included participants were patients 40 years or older, with systolic BP (SBP) over 145 mm Hg and/or diastolic BP (DBP) over 90 mm Hg, recruited from July 21, 2017, to June 30, 2018 (study completion, August 25, 2020). Statistical analysis was conducted on an intention-to-treat basis from August 2022 to February 2024. Interventions: Participants were randomized 1:1 to usual care vs an individualized, prearranged plan based on BP self-monitoring plus medication self-titration. Main Outcomes and Measures: The main outome was the adjusted mean difference (AMD) in SBP between groups at 24 months of follow-up. Secondary outcomes were the AMD in DBP between groups at 24 months of follow-up, proportion of patients reaching the BP target (SBP <140 mm Hg and DBP <90 mm Hg), change in behaviors, quality of life, health service use, and adverse events. Results: Among 312 patients included in main trial, data on BP measurements at 24 months were available for 219 patients (111 in the intervention group and 108 in the control group). The mean (SD) age was 64.3 (10.1) years, and 120 patients (54.8%) were female; the mean (SD) SBP was 155.6 (13.1) mm Hg, and the mean (SD) diastolic BP was 90.8 (7.7) mm Hg. The median follow-up was 23.8 months (IQR, 19.8-24.5 months). The AMD in SBP at the end of follow-up was -3.4 mm Hg (95% CI, -4.7 to -2.1 mm Hg; P < .001), and the AMD in DBP was -2.5 mm Hg (95% CI, -3.5 to -1.6 mm Hg; P < .001). Subgroup analysis for the main outcome showed consistent results. Sensitivity analyses confirmed the robustness of the main findings. No differences were observed between groups in behaviors, quality of life, use of health services, or adverse events. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, BP self-monitoring plus self-titration of antihypertensive medication based on an individualized prearranged plan used in primary care reduced BP in the longer term with passive follow-up compared with usual care, without increasing health care use or adverse events. These results suggest that simple, inexpensive, and easy-to-implement self-management interventions have the potential to improve the long-term control of hypertension in routine clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT03242785.
Subject(s)
Antihypertensive Agents , Blood Pressure Monitoring, Ambulatory , Hypertension , Humans , Female , Hypertension/drug therapy , Male , Middle Aged , Antihypertensive Agents/therapeutic use , Antihypertensive Agents/administration & dosage , Blood Pressure Monitoring, Ambulatory/methods , Aged , Spain , Blood Pressure/drug effects , Self Care/methodsABSTRACT
La aterotrombosis es una de las principales causas de mortalidad en todo el mundo. Constituye un importante problema para la salud pública en España, al igual que en el resto de los países, y constituye una prioridad asistencial. El objetivo del registro REACH (REduction of Atherothrombosis for Continued Health) es analizar el riesgo a largo plazo de los episodios aterotrombóticos en la población de riesgo, evaluar la importancia del riesgo cruzado y definir los factores pronósticos de los episodios aterotrombóticos. En el registro REACH se han inscrito más de 68.000 pacientes en más de 5.000 centros distribuidos en 44 países, de los cuales 2.252 se encuentran en España. Como en los resultados a escala mundial, en los pacientes españoles la tasa de complicaciones, solamente al año de seguimiento, fue alta. La tasa anual de mortalidad global en los pacientes con enfermedad vascular establecida (EV) o en prevención primaria pero con alto riesgo aterotrombótico, representado por los pacientes con sólo factores de riesgo, fue del 3,57 y del 1,98%, respectivamente, la de mortalidad cardiovascular del 2,69 y del 0,62%. Las tasas según el territorio afectado fueron, en los subgrupos de enfermedad coronaria, enfermedad cerebrovascular y en el de enfermedad arterial periférica, del 3,47, del 2,78 y del 1,46%, respectivamente. La afección de más de un territorio es claramente un factor de mal pronóstico, de forma que la tasa anual de complicaciones se incrementó según tuvieran 0, 1, 2 o 3 territorios vasculares afectados, respectivamente, para la mortalidad cardiovascular (0,62, 2,46, 3,55 y 4,32%; p < 0,05) y para el conjunto de mortalidad cardiovascular más infarto, más ictus y más hospitalización cardiovascular (5,50, 4,18, 20,59 y 19,40%). Es importante resaltar el mal pronóstico de estos pacientes, incluso a corto plazo, especialmente en aquellos con enfermedad vascular establecida y tanto peor cuanto más extensa sea la afectación vascular. Por ello es necesario mejorar esta situación, identificando más precozmente a los sujetos de alto riesgo y optimizando las medidas preventivas, tanto en prevención primaria como secundaria (AU)
Atherothrombosis is one of the main causes of death worldwide. In Spain, as in other countries, this disease is a major public health problem, constituting a healthcare priority. The aim of the REduction of Atherothrombosis for Continued Health (REACH) registry is to analyze the long-term risk of atherothrombotic episodes in the at-risk population, evaluate the importance of cross risk, and define the prognostic factors of atherothrombotic episodes. More than 68,000 patients in more than 5,000 centers in 44 countries have been included in the REACH registry, of which 2,252 live in Spain. As observed internationally, in Spanish patients the complication rate at only 1-year of follow-up was high. The annual overall mortality rate in patients with established vascular disease or under primary prevention but with high atherothrombotic risk, represented by patients with risk factors only, was 3.57% and 1.98%, respectively, while that of cardiovascular mortality was 2.69% and 0.62%. In the subgroups of coronary artery disease (CAD), cerebral vascular disease (CVD) and peripheral artery disease (PAD) rates according to the affected territory were 3.47%, 2.78% and 1.46%, respectively. Involvement of more than one territory was clearly a poor prognostic factor: the annual complications rate increased according to whether 0, 1, 2, or 3 vascular beds were diseased for cardiovascular mortality (0.62%, 2.46%, 3.55% and 4.32%, respectively, p < 0.05) and for cardiovascular mortality, plus myocardial infarction, plus stroke, plus hospitalization for cardiovascular reasons these rates were 5.50%, 4.18%, 20.59% and 19.40%. Importantly, these patients have a poor prognosis even in the short-term, especially those with established vascular disease; furthermore, the greater the number of diseased vascular beds, the poorer the prognosis. This situation must therefore be improved by earlier identification of at-risk individuals and by optimizing both primary and secondary preventive measures (AU)
Subject(s)
Aged , Female , Humans , Male , Arteriosclerosis/epidemiology , Arteriosclerosis/prevention & control , Myocardial Infarction/epidemiology , Myocardial Infarction/prevention & control , Registries , Stroke/epidemiology , Stroke/prevention & control , Thrombosis/epidemiology , Thrombosis/prevention & control , Spain , Time FactorsABSTRACT
La aterotrombosis es una enfermedad sistémica que puede expresarse por la afectación de diferentes territorios vasculares, siendo más frecuentemente el coronario, vasculocerebral o el arterial periférico el que lleva a su diagnóstico. La ateromatosis aórtica o de sus ramas puede ser asintomática o manifestarse clínicamente en forma de isquemia meséntérica o nefropatía isquémica. Es, por ello, una patología que afecta a diferentes especialidades médicas y ámbitos asistenciales, como la cardiología, la neurología, la nefrología, la endocrinología, la cirugía vascular, la medicina interna y la atención primaria. La afectación simultánea de diferentes territorios, de forma sintomática o asintomática, hace necesario un abordaje global, multidisciplinar y coordinado. Adicionalmente, la actuación médica no debe limitarse al tratamiento del accidente agudo, y el pilar clave lo constituye la prevención, tanto primaria como secundaria. Es aquí donde, especialmente, las especialidades con visión global, como la medicina interna o los médicos de atención primaria, deben tener un papel coordinador y prioritario. Esta intervención multidisciplinar afecta no solamente al personal facultativo, sino también a otro tipo de personal sanitario, como dietistas, especialistas en ejercicio físico y, muy especialmente, a la enfermería, que debe desempeñar un papel clave en el control de los factores de riesgo, en la educación sanitaria y en la monitorización de adherencia al tratamiento (AU)
Atherothrombosis is a systemic disease that can manifest as involvement of distinct vascular territories; those most frequently leading to diagnosis being coronary, cerebrovascular and peripheral arterial vascular territories. Atheromatosis of the aorta or its branches can be asymptomatic or manifest clinically in the form of mesenteric ischemia or ischemic nephropathy. Atherothrombosis therefore involves distinct medical specialities and healthcare levels such as cardiology, neurology, nephrology, endocrinology, vascular surgery, internal medicine, and primary care. Simultaneous involvement of more than one vascular territory, whether symptomatic or asymptomatic, requires a global, multidisciplinary and coordinated approach. Additionally, medical intervention should not be limited to treatment of the acute accident as prevention, both primary and secondary, is a key factor in the management of this disease. It is here that specialties with an overall view such as internal medicine or primary care are especially well placed to play a fundamental and coordinating role. This multidisciplinary intervention involves not only physicians but also other health professionals such as dieticians, physical exercise specialists and, especially, nurses, who should play a key role in controlling risk factors, in health education and in monitoring treatment adherence (AU)