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

I RBH – Primeiro registro brasileiro de hipertensão arterial

Background: A registry assessing the care of hypertensive patients in daily clinical practice in public and private centers in various Brazilian regions has not been conducted to date. Such analysis is important to elucidate the effectiveness of this care. Objective: To document the current clinical practice for the treatment of hypertension with identification of the profile of requested tests, type of administered treatment, level of blood pressure (BP) control, and adherence to treatment. Methods: National, observational, prospective, and multicenter study that will include patients older than 18 years with hypertension for at least 4 weeks, following up in public and private centers and after signing a consent form. The study will exclude patients undergoing dialysis, hospitalized in the previous 30 days, with class III or IV heart failure, pregnant or nursing, with severe liver disease, stroke or acute myocardial infarction in the past 30 days, or with diseases with a survival prognosis 18 anos, hipertensos há ≥ 4 semanas, em acompanhamento em serviços públicos e privados e com assinatura do consentimento. Serão excluídos pacientes em diálise, internados nos últimos 30 dias, com insuficiência cardíaca classe III ou IV, gravidez ou amamentação, hepatopatia grave, acidente vascular cerebral ou infarto agudo nos 30 dias anteriores e doenças com prognóstico de sobrevida < 1 ano. As avaliações serão realizadas ao início e final do estudo, após acompanhamento por 1 ano. Parâmetros a serem avaliados incluirão dados antropométricos, hábitos de vida, PA, perfil lipídico, síndrome metabólica e adesão ao tratamento. Os desfechos primários serão internação por crise hipertensiva, evento cardiocirculatório e óbito cardiovascular, e os desfechos secundários serão internação por insuficiência cardíaca e necessidade de diálise. Uma análise de subgrupo avaliará a pressão central de forma não invasiva em 15% da amostra no início e final do estudo. A amostra estimada é de 3.000 indivíduos para prevalência de 5%, erro amostral de 2% e intervalo de confiança de 95%. Resultados: Os resultados serão apresentados após a avaliação final que ocorrerá quando encerrado 1 ano de seguimento. Conclusão: A análise deste registro trará melhor conhecimento sobre o tratamento da hipertensão no Brasil e possibilitará a otimização do mesmo, como forma de interferir no prognóstico da doença cardiovascular em nosso meiosem informaçã

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