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

Intestinal parasitic infections in HIV/AIDS patients: epidemiological, nutritional and immunological aspects

This study applied a socioeconomic questionnaire designed to evaluate the frequency of intestinal parasites and characterize epidemiological, nutritional, and immunological variables in 105 HIV/AIDS patients - with and without parasitic infections, attending the Day Hospital in Botucatu, UNESP, from 2007 to 2008. Body mass index was calculated and the following tests performed: parasitological stool examinations; eosinophil, IgE, CD4+ T and CD8+ T lymphocyte cell counts; albumin test; viral load measure; and TNF-&#945;, IFN-&#947;, IL-2, IL-5 and IL-10 cytokine levels. Results were positive for parasitic intestinal infections in 12.4% of individuals. Most patients had good socioeconomic conditions with basic sanitation, urban dwellings, treated water supply and sewage, good nutritional and immunological status and were undergoing HAART. Parasites were found at the following frequencies: Entamoeba - five patients (38.5%), Giardia lamblia - four (30.7%), Blastocystis hominis - three (23.0%), Endolimax nana - two (15.4%), and Ascaris lumbricoides - one (7.7%). There were no significant differences between the two groups for eosinophils, albumin, IgE, CD4+ T and CD8+ T lymphocytes, INF-&#947;, IL-2, or IL-10. Most patients also showed undetectable viral load levels. Significant differences were found for TNF-&#945; and IL-5. These results show the importance of new studies on immunodeficient individuals to increase understanding of such variables

Reinternação em hospital psiquiátrico: a compreensão do processo saúde/doença na vivência do cotidiano Reinternamiento en hospital psiquiátrico: la comprensión del proceso salud/enfermedad en la vivencia del cotidiano Readmission to a psychiatric hospital: the comprehension of the health/illness process through the experience of daily life

Este trabalho é recorte de uma investigação que buscou identificar o cotidiano de pessoas com transtornos mentais, que sofrem reinternações psiquiátricas. Nesse percurso foi possível evidenciar que esses sujeitos expressam diversas concepções do processo saúde/doença mental e que caracterizam as formas de tratamento que se utilizam. Utilizou-se como metodologia a abordagem qualitativa fundamentada no conceito de cotidiano da autora Agnes Heller. As entrevistas de pacientes e familiares foram submetidas à análise de discurso que, entre outros resultados, revelou que essa população passou a ter novas ferramentas e possibilidades para compreender a loucura e a assistência ao doente mental.<br>Este trabajo es recorte de una investigación que buscó identificar el cotidiano de personas con trastornos mentales, que sufren reinternamientos psiquiátricos. En este recorrido fue posible evidenciar que esos sujetos expresan diversas concepciones del proceso salud/enfermedad mental y que caracterizan las formas de tratamiento utilizados. En la metodología se utilizó el abordaje cualitativo fundamentado en el concepto de cotidiano de la autora Agnes Heller. Las entrevistas de pacientes y familiares fueron sometidas al análisis de discurso que, entre otros resultados, reveló que esa población pasó a tener nuevas herramientas y posibilidades para comprender la locura y la asistencia al enfermo mental.<br>This study is part of a research that aimed at identifying the daily life of people with mental disruptions who are re-admitted to psychiatric hospitals. It was possible to pinpoint that these individuals express several conceptions of the health/mental illness process and that they also distinguish the kinds of treatment they go through. As far as methodology is concerned the study used the qualitative approach based on Agnes Heller's concept of daily life. The interviews with patients and their relatives were submitted to speech analysis, which showed, among other results, that relatives have developed new tools and possibilities in order to understand the patients' mental state and provide them with the necessary assistance