Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)

Validade de conteúdo nos processos de construção e adaptação de instrumentos de medidas Content validity in the development and adaptation processes of measurement instruments

Este estudo teve por objetivo realizar uma revisão sobre validade de conteúdo, fase importante nos processos de construção e adaptação de instrumentos de medida. Foi realizada pesquisa bibliográfica definida como integrativa, por meio de pesquisa a bases de dados nacionais e internacionais. Iniciou-se a descrição das bases conceituais e os métodos de medidas usados em validade de conteúdo, com ênfase na área da saúde. Verificou-se que existem controvérsias na literatura sobre a terminologia e o conceito da validade de conteúdo. Foram descritos os procedimentos recomendados para realizar a validade de conteúdo durante os processos de construção e de adaptação de instrumentos, particularmente a avaliação por juízes, o que pode envolver procedimentos qualitativos e quantitativos. Descreveu-se número, seleção e qualificação desses juízes. Os diferentes métodos para quantificar o grau de concordância entre os especialistas foram analisados, principalmente o Índice de Validade de Conteúdo (IVC). Este estudo descreveu aspectos do processo de realização da validade de conteúdo, um dos procedimentos a serem considerados por pesquisadores e profissionais da área de saúde preocupados em utilizarem medidas e instrumentos confiáveis e apropriados para determinada população.<br>This study sought to conduct a review of content validity, which is an important phase of processes of construction and adaptation of measurement instruments. Research of comprehensive literature was conducted by means of a review of national and international databases. Initially, a description of the conceptual basis and the measurement methods used in content validity was made, with emphasis on its application in the healthcare area. It was seen that controversy exists in the literature on the terminology and concept of content validity. The recommended procedures used to check content validity during the construction and adaptation processes of instruments were described, especially the judges' assessment, which can involve qualitative and quantitative procedures. The number, selection and qualification of these judges were also described. The different methods used to quantify the level of agreement among the experts were verified, mainly the Content Validity Index (CVI). This study described aspects of the content validity process, one of the procedures to be considered by healthcare researchers and professionals who are interested in using reliable and appropriate measurements and instruments scales for given population groups