Reduction in Total Cardiovascular Events With Ezetimibe/Simvastatin Post-Acute Coronary Syndrome The IMPROVE-IT Trial

AbstractBackgroundIntensive low-density lipoprotein cholesterol therapy with ezetimibe/simvastatin in IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) significantly reduced the first primary endpoint (PEP) in patients post-acute coronary syndrome (ACS) compared to placebo/simvastatin.ObjectivesThis analysis tested the hypothesis that total events, including those beyond the first event, would also be reduced with ezetimibe/simvastatin therapy.MethodsAll PEP events (cardiovascular [CV] death, myocardial infarction [MI], stroke, unstable angina [UA] leading to hospitalization, coronary revascularization ≥30 days post-randomization) during a median 6-year follow-up were analyzed in patients randomized to receive ezetimibe/simvastatin or placebo/simvastatin in IMPROVE-IT. Negative binomial regression was used for the primary analysis.ResultsAmong 18,144 patients, there were 9,545 total PEP events (56% were first events and 44% subsequent events). Total PEP events were significantly reduced by 9% with ezetimibe/simvastatin vs placebo/simvastatin (incidence-rate ratio [RR]: 0.91; 95% confidence interval [CI]: 0.85 to 0.97; p = 0.007), as were the 3 pre-specified secondary composite endpoints and the exploratory composite endpoint of CV death, MI, or stroke (RR: 0.88; 95% CI: 0.81 to 0.96; p = 0.002). The reduction in total events was driven by decreases in total nonfatal MI (RR: 0.87; 95% CI: 0.79 to 0.96; p = 0.004) and total NF stroke (RR: 0.77; 95% CI: 0.65 to 0.93; p = 0.005).ConclusionsLipid-lowering therapy with ezetimibe plus simvastatin improved clinical outcomes. Reductions in total PEP events, driven by reductions in MI and stroke, more than doubled the number of events prevented compared with examining only the first event. These data support continuation of intensive combination lipid-lowering therapy after an initial CV event. (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial [IMPROVE-IT]; NCT00202878

Effect of nesiritide in patients with acute decompensated heart failure

Background Nesiritide is approved in the United States for early relief of dyspnea in patients with acute heart failure. Previous meta-analyses have raised questions regarding renal toxicity and the mortality associated with this agent. Methods We randomly assigned 7141 patients who were hospitalized with acute heart failure to receive either nesiritide or placebo for 24 to 168 hours in addition to standard care. Coprimary end points were the change in dyspnea at 6 and 24 hours, as measured on a 7-point Likert scale, and the composite end point of rehospitalization for heart failure or death within 30 days. Results Patients randomly assigned to nesiritide, as compared with those assigned to placebo, more frequently reported markedly or moderately improved dyspnea at 6 hours (44.5% vs. 42.1%, P = 0.03) and 24 hours (68.2% vs. 66.1%, P = 0.007), but the prespecified level for significance (P≤0.005 for both assessments or P≤0.0025 for either) was not met. The rate of rehospitalization for heart failure or death from any cause within 30 days was 9.4% in the nesiritide group versus 10.1% in the placebo group (absolute difference, −0.7 percentage points; 95% confidence interval [CI], −2.1 to 0.7; P = 0.31). There were no significant differences in rates of death from any cause at 30 days (3.6% with nesiritide vs. 4.0% with placebo; absolute difference, −0.4 percentage points; 95% CI, −1.3 to 0.5) or rates of worsening renal function, defined by more than a 25% decrease in the estimated glomerular filtration rate (31.4% vs. 29.5%; odds ratio, 1.09; 95% CI, 0.98 to 1.21; P = 0.11). Conclusions Nesiritide was not associated with an increase or a decrease in the rate of death and rehospitalization and had a small, nonsignificant effect on dyspnea when used in combination with other therapies. It was not associated with a worsening of renal function, but it was associated with an increase in rates of hypotension. On the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure. (Funded by Scios; ClinicalTrials.gov number, NCT00475852.

Meta-analysis of personality trait differences between omnivores, vegetarians, and vegans

Vegetarian and vegan diets have been increasing in the Western world. Recent research has focused on personality trait differences between dietary groups, in part because personality traits are broad characteristics that can integrate findings about different factors that motivate vegetarian or vegan diets. Previous research on personality predictors of vegetarian and vegan (veg*n) diet, however, has yielded inconsistent results. The goal of this study was to integrate the existing results of Big Five personality differences between veg*ns and omnivores as well as between vegetarians and vegans. To this end, we meta-analyzed data from 15 studies and N = 69,576 individuals from several countries. Results indicated that veg*ns were significantly higher in Openness (d = 0.40) and Agreeableness (d = 0.17) than omnivores, while vegans were significantly higher in Openness (d = 0.14) than vegetarians. This work isolates Openness and Agreeableness as important trait predictors of plant-based diets and sets the stage for future work on the factors that motivate vegetarian or vegan diet. Personality traits can provide an integrative framework for conceptualizing dietary preferences, be used to make predictions about the sources, course and correlates of dietary choices, and potentially be useful for advocates and policymakers seeking to tailor meat-reduction interventions

Collaborative mental health care: a narrative review.

The Collaborative Care model is a systematic strategy for treating behavioral health conditions in primary care through the integration of care managers and psychiatric consultants. Several randomized controlled trials have demonstrated that Collaborative Care increases access to mental health care and is more effective and cost efficient than the current standard of care for treating common mental illnesses. Large healthcare systems and organizations have begun to adopt Collaborative Care initiatives and are seeing improved treatment outcomes and provider and patient satisfaction. This review discusses current research on the effectiveness and cost-efficiency of Collaborative Care. In addition, this paper discusses its ability to adapt to specific patient populations, such as geriatrics, students, substance use, and women with perinatal depression, as well as the significance of measurement-based care and mental health screening in achieving improved clinical outcomes. Current data suggests that Collaborative Care may significantly improve patient outcomes and time-to-treatment in all reviewed settings, and successfully adapts to special patient populations. Despite the high upfront implementation burden of launching a Collaborative Care model program, these costs are generally offset by long term healthcare savings

Preferences for family involvement among veterans in treatment for schizophrenia.

OBJECTIVE: Examine preferences for family involvement in psychiatric care in a large, representative sample of veterans in treatment for schizophrenia. METHOD: Veterans with schizophrenia or schizoaffective disorder (N = 801) completed an assessment that included questions about demographic and clinical characteristics, status of family support, and preference for family involvement in their psychiatric care. Open-ended items were independently coded by two raters and categorized; Cohens kappa was calculated for each category. RESULTS: Among the 801 participants, 496 (61.9%) indicated that they had a family member who provided them with regular support; 304 (37.9%) had no family member who provided support; and 1 did not respond. Among the 304 without support, 272 (89.4%) had a living family member. Of the 496 participants who had a supportive family member, 135 (27.2%) wanted their family member involved in their care. Of the 272 participants who did not have a supportive family member, but had living family, 57 (21.0%) wanted their family involved. Barriers to involvement included concerns about privacy and burden. Preferred method of involvement included contact with the patients psychiatrist and education about the illness. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Preferences indicated by this large representative sample of individuals in care for schizophrenia indicate that a majority have supportive family and a substantial minority want family involved in their psychiatric care. Clinicians can address concerns about privacy and burden and deliver preferred services by phone or mail, overcoming anticipated barriers. Desire for family support groups was limited but present. (PsycINFO Database Record (c) 2019 APA, all rights reserved)