Effects of alirocumab on types of myocardial infarction: insights from the ODYSSEY OUTCOMES trial

Aims  The third Universal Definition of Myocardial Infarction (MI) Task Force classified MIs into five types: Type 1, spontaneous; Type 2, related to oxygen supply/demand imbalance; Type 3, fatal without ascertainment of cardiac biomarkers; Type 4, related to percutaneous coronary intervention; and Type 5, related to coronary artery bypass surgery. Low-density lipoprotein cholesterol (LDL-C) reduction with statins and proprotein convertase subtilisin–kexin Type 9 (PCSK9) inhibitors reduces risk of MI, but less is known about effects on types of MI. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome (ACS) and elevated LDL-C (≥1.8 mmol/L) despite intensive statin therapy. In a pre-specified analysis, we assessed the effects of alirocumab on types of MI. Methods and results  Median follow-up was 2.8 years. Myocardial infarction types were prospectively adjudicated and classified. Of 1860 total MIs, 1223 (65.8%) were adjudicated as Type 1, 386 (20.8%) as Type 2, and 244 (13.1%) as Type 4. Few events were Type 3 (n = 2) or Type 5 (n = 5). Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77–0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77–0.99; P = 0.032) and Type 2 (0.77, 0.61–0.97; P = 0.025), but not Type 4 MI. Conclusion  After ACS, alirocumab added to intensive statin therapy favourably impacted on Type 1 and 2 MIs. The data indicate for the first time that a lipid-lowering therapy can attenuate the risk of Type 2 MI. Low-density lipoprotein cholesterol reduction below levels achievable with statins is an effective preventive strategy for both MI types.For complete list of authors see http://dx.doi.org/10.1093/eurheartj/ehz299</p

Effect of alirocumab on mortality after acute coronary syndromes. An analysis of the ODYSSEY OUTCOMES randomized clinical trial

Background: Previous trials of PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitors demonstrated reductions in major adverse cardiovascular events, but not death. We assessed the effects of alirocumab on death after index acute coronary syndrome. Methods: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) was a double-blind, randomized comparison of alirocumab or placebo in 18 924 patients who had an ACS 1 to 12 months previously and elevated atherogenic lipoproteins despite intensive statin therapy. Alirocumab dose was blindly titrated to target achieved low-density lipoprotein cholesterol (LDL-C) between 25 and 50 mg/dL. We examined the effects of treatment on all-cause death and its components, cardiovascular and noncardiovascular death, with log-rank testing. Joint semiparametric models tested associations between nonfatal cardiovascular events and cardiovascular or noncardiovascular death. Results: Median follow-up was 2.8 years. Death occurred in 334 (3.5%) and 392 (4.1%) patients, respectively, in the alirocumab and placebo groups (hazard ratio [HR], 0.85; 95% CI, 0.73 to 0.98; P=0.03, nominal P value). This resulted from nonsignificantly fewer cardiovascular (240 [2.5%] vs 271 [2.9%]; HR, 0.88; 95% CI, 0.74 to 1.05; P=0.15) and noncardiovascular (94 [1.0%] vs 121 [1.3%]; HR, 0.77; 95% CI, 0.59 to 1.01; P=0.06) deaths with alirocumab. In a prespecified analysis of 8242 patients eligible for ≥3 years follow-up, alirocumab reduced death (HR, 0.78; 95% CI, 0.65 to 0.94; P=0.01). Patients with nonfatal cardiovascular events were at increased risk for cardiovascular and noncardiovascular deaths (P<0.0001 for the associations). Alirocumab reduced total nonfatal cardiovascular events (P<0.001) and thereby may have attenuated the number of cardiovascular and noncardiovascular deaths. A post hoc analysis found that, compared to patients with lower LDL-C, patients with baseline LDL-C ≥100 mg/dL (2.59 mmol/L) had a greater absolute risk of death and a larger mortality benefit from alirocumab (HR, 0.71; 95% CI, 0.56 to 0.90; Pinteraction=0.007). In the alirocumab group, all-cause death declined wit h achieved LDL-C at 4 months of treatment, to a level of approximately 30 mg/dL (adjusted P=0.017 for linear trend). Conclusions: Alirocumab added to intensive statin therapy has the potential to reduce death after acute coronary syndrome, particularly if treatment is maintained for ≥3 years, if baseline LDL-C is ≥100 mg/dL, or if achieved LDL-C is low. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402

A Teoria de King e sua interface com o programa "Saúde da Família" La teoría de king y su interrelación con el programa "salud de la familia" King´s theory and its interface with the "family health" program

Trata-se de estudo de intenção epistemológica acerca da teoria do alcance de metas de King e suas contribuições para o conhecimento e prática de enfermeiros que atuam no Programa "Saúde da Família" (PSF), Brasil. Aplicou-se o componente Análise, do Método de Análise de Teorias de Meleis na reflexão crítica sobre a teoria, e tomou-se de leituras e reflexões quanto às diretrizes e propostas do PSF para perceber a interface entre os dois paradigmas em estudo. Identificou-se haver coerência entre as duas propostas de abordagem, o que leva as autoras a recomendarem a adoção dos ensinamentos de King na prática do PSF, no sentido da enfermagem obter maiores e melhores resultados de suas ações.<br>Se trata de un estudio de intención epistemológica respecto a la teoría del alcance de metas de King y sus contribuciones al conocimiento y la práctica de los enfermeros que actúan en el Programa "Salud de la Familia" (PSF), Brasil. Se utilizó el componente Análisis, del Método de Análisis de Teorías de Meleis, al referirse a la reflexión crítica sobre la teoría; también se tomaron las lecturas y reflexiones relacionadas a las directrices y propuestas del PSF para percibir la interface entre los dos paradigmas en estudio. Se identificó que hay coherencia entre las dos propuestas abordadas, lo cual condujo a las autoras a recomendar la adopción de las enseñanzas de King dentro de la práctica de PSF, con la idea de que la enfermería obtenga mayores y mejores resultados en sus acciones.<br>This study of epistemological intention is about King's goal achievement theory and its contributions on knowledge and practicing for nurses who work in the "Family Health" Program (FHP), Brazil. The analysis component, based on the Meleis' Method of Theory Analysis concerning critical thought on the theory, was applied as well as reading and thoughts on FHP guidelines and proposals in order to verify the interface between the two paradigms in the study. The outcome of the study proves that the two approaching proposals are coherent. Such coherence drives authors to recommend the adoption of King's teachings concerning FHP practice for nursing to obtain greater and better results in its actions

Estressores vivenciados pelos familiares no processo de doação de órgãos e tecidos para transplante Estresores experimentados por los familiares en el proceso de donación de órganos y tejidos para transplante Stressor experienced by family members in the process of organ and tissue donation for transplant

O estudo propõe identificar os estressores vivenciados pelos familiares no processo de doação de órgãos, evidenciar o momento mais desgastante do processo e verificar a associação de variáveis com a experiência vivenciada pelos familiares. A amostra constituiu-se de 16 familiares que realizaram a doação por meio de uma Organização de Procura de Órgãos, na cidade de São Paulo, em 2007. Utilizou-se um instrumento estruturado com questões versando sobre a experiência e avaliação dos familiares no processo de doação. Os principais estressores foram: insatisfação com o atendimento (31,25%); receber a notícia da morte encefálica de forma intranquila (62,50%); e a demora para a liberação do corpo (62,50%), sendo este o momento mais desgastante do processo. Pelo coeficiente phi, verificou-se associação moderada entre as variáveis de interesse com a experiência da família. Conclui-se que o processo de doação é estressante para a família e que a assistência de enfermagem torna-se necessária em cada etapa da doação, oferecendo suporte para diminuir o sofrimento dos familiares.<br>El estudio propone identificar los estresores experimentados por los familiares en el proceso de donación de órganos, evidenciar el momento más desgastante y verificar la asociación de variables con la experiencia afrontada por los familiares. La muestra se constituyó de 16 familiares que realizaron la donación en una Organización de Búsqueda de Órganos de la ciudad de São Paulo, en 2007. Se utilizó un instrumento estructurado con preguntas referidas a la experiencia y evaluación de los familiares en el proceso de donación. Lo principales estresores fueron: la insatisfacción con la atención (31,25%); recibir la noticia de muerte encefálica en forma impropia (62,50%) y la demora para la liberación del cuerpo (62,50%), siendo éste el momento más desgastante. Por el coeficiente Phi, se verificó asociación moderada entre las variables de interés con la experiencia de la familia. Concluyendo, el proceso de donación de órganos es estresante para la familia, y la atención de enfermería se vuelve necesaria en cada etapa de la donación, brindando apoyo para disminuir el sufrimiento de los familiares.<br>The purpose of the present study is to identify the stressors experienced by family members during the process of organ donation, evince the most distressful moment of the process and verify the association of variable with the family members' experience. The sample consisted of 16 family members that were making the donation through a Organ Search Organization, in São Paulo, in 2007. A structured instrument was used, containing question addressing the family members' experience and their evaluation of the donation process. The main stressors reported were: dissatisfaction with the service (31.25%); receiving a harsh notification about the individual's brain death (62.50%); and the wait to release the body (62.50%), which was considered the most distressful moment of the process. Using the phi coefficient, it was found that there was a moderate association between the variables of interest with the family's experience. In conclusion, the donation process is stressful on the family and nursing care is necessary in each stage of the process to offer support and reduce the distress on the family members

Exploitation and alienation of the body of the nurse: a phenomenological study Explotación y alienación del cuerpo de la enfermera: un estudio fenomenológico A exploração e alienação do corpo da enfermeira: um estudo fenomenológico

OBJECTIVE: To understand the experience of being woman, mother, and nurse. METHODS: This phenomenological study was conducted in a teaching hospital in Curitiba, Brazil from June 2005 to March 2006. The sample consisted of seven nurses. Data were collected through semi-structured interviews. RESULTS: The main emerged theme was "Exploitation and alienation of the body of the nurse until its exhaustation." CONCLUSION: Nurses have difficulties in assuming other roles in professional organizations and institutional administration due to workload and exhaustion in performing their personal and professional tasks.<br>OBJETIVO: Comprender cómo se percibe el cuerpo femenino al vivenciar la experiencia del ser mujer, madre enfermera. MÉTODOS: Se trata de un estudio fenomenológico realizado con siete enfermeras en un Hospital de enseñanza público de Curitiba-Paraná, de junio del 2005 a marzo del 2006. Los discursos fueron obtenidos mediante entrevista semi-estructurada grabada. RESULTADOS: El tema destacado es: La explotación y alienación del cuerpo de la enfermera llevando al agotamiento. CONCLUSIONES: Los discursos expresan la dificultad de las enfermeras para asumir otras funciones junto a órganos de clase, administración de la institución, en virtud de la sobrecarga y del agotamiento al que están sometidas en el cotidiano personal y profesional.<br>OBJETIVO: Compreender como o corpo feminino se percebe ao vivenciar a experiência do ser mulher, mãe e enfermeira. MÉTODOS: Estudo fenomenológico realizado em hospital de ensino público de Curitiba- PR, de junho de 2005 a março de 2006, com sete enfermeiras. Os discursos foram obtidos mediante entrevista semi-estruturada gravada. RESULTADOS: O tema destacado é: A exploração e alienação do corpo da enfermeira levando à exaustão. CONCLUSÕES: Os discursos expressam a dificuldade das enfermeiras assumirem outras funções junto a órgãos de classe, administração da instituição, em virtude da sobrecarga e da exaustão a que estão submetidas no cotidiano pessoal e profissional

Atuação dos pais na prevenção da hipertensão arterial : uma tecnologia educativa em saúde Parents' actions for prevention of arterial hypertension educational technology for health

Pesquisa participante com o objetivo de avaliar as mudanças comportamentais em quinze pais de alunos do pré-escolar na prevenção dos fatores de risco da hipertensão arterial, a partir da aplicação de uma tecnologia educativa em saúde com base no Modelo de Crenças em Saúde, em uma escola privada de Fortaleza-CE. A pesquisa de campo foi realizada por meio de oficinas educativas e a coleta de dados via questionários e entrevistas. Após se organizar os dados em categorias, fundamentou-se a análise nos pressupostos da educação em saúde. Com a aplicação da tecnologia educativa em saúde, constataram-se mudanças significativas nos hábitos dos pais, além dos papéis assumidos agente de mudança e de multiplicador das ações educativas na família. Contudo houve dificuldades no processo de mudança, mas os pais estavam motivados para a prevenção dos fatores de risco da hipertensão arterial em si e nos filhos. Então, essa tecnologia educativa embasada no Modelo de Crenças em Saúde, mostrou-se eficiente, pois ocorreram mudanças comportamentais significativas, bem como motivação dos pais para a prevenção da hipertensão arterial mediante um estilo de vida saudável.<br>This participatory research aimed to evaluate behavioral changes in fifteen parents of pre-school children to prevent the risk factors of arterial hypertension, by applying education technology for health that is based on the Health Beliefs Model at a private school in Fortaleza, State of Ceará, Brazil. The field research was carried out through educational workshops and data collection through questionnaires and interviews. After organizing the data into categories, analysis was based on the premises of health education. Through the application of education technology for health, significant changes were observed in the parents' habits, besides the roles they assumed as agents of change and multipliers of educational actions in the family. Although difficulties arose in the process of change, the parents were motivated to prevent the risk factors of arterial hypertension in themselves and their children. Thus, education technology for health based on the Health Beliefs Model proved to be efficient, as significant behavioral changes occurred and the parents were motivated to prevent arterial hypertension by means of a healthy lifestyle