Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Cultura organizacional brasileira pós-globalização: global ou local? Brazilian cultural organization in post-globalization: global or local?

Um dos grandes desafios para pesquisadores de gestão internacional é compreender a diversidade institucional e cultural dos ambientes de negócios nacionais. Para responder a tal desafio, os pesquisadores recorrem a agrupamentos e generalizações. Embora tal recurso metodológico apresente inegáveis méritos, pode prover quadros relativamente pobres sobre a realidade de cada país. Este artigo procura endereçar essa lacuna. Realizamos uma pesquisa exploratória sobre os traços da cultura organizacional brasileira hoje, após 17 anos de abertura econômica e transformações institucionais, as quais geraram profundos impactos na sociedade e nas organizações. Exploramos a literatura existente sobre traços da cultura organizacional brasileira e apresentamos um estudo de campo baseado em entrevistas com profissionais estrangeiros que trabalham no Brasil e com profissionais brasileiros que já trabalharam fora do país. A comparação entre os estudos anteriores e o presente estudo revela um quadro híbrido, transitório e com ressignificações, típico de um período de transição marcado pela convivência entre traços pré-globalização e traços pós-globalização.<br>A great challenge facing international management researchers is understanding the institutional and cultural diversity of national business environments. In response to this challenge, researchers often resort to pooling and generalizations. Despite the undeniable merits of such a methodological approach, it may provide relatively poor descriptions of each country's reality. The purpose of this article is to address this gap. We carried out an exploratory research of Brazil's organizational culture today, after 17 years of economic openness and institutional changes that have led to deep impacts on society and organizations. We explored the existing literature on traits of Brazil's organizational culture and present a field study based on interviews with foreign professionals working in Brazil and with Brazilian professionals with overseas experience. Comparison of the present study with previous ones shows a hybrid picture typical of a transition period marked by the coexistence of pre-and post-globalization traits

Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects.

BACKGROUND: The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. METHODS: We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). RESULTS: The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased. CONCLUSIONS: Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.

Toward a Theory of Organizational Integration

In this chapter, the authors theorize organizational integration by extending, elaborating, and combining various theoretical perspectives, such as structural contingency theory, organization economics, and organizational culture. The aim of this study is to provide the foundation for a holistic theory of integration that examines the different relevant facets of integration and a comprehensive set of tools – integrative devices – by which integration can be sought by those who design the organization. To this end, the authors examine the integration challenge that arises from various types of subunit interdependence – pooled, sequential, and reciprocal – and theorize which configurations of integrative devices are more likely to be effective in a given task environment. The authors close by discussing directions for future research on organizational integration

Collaborative organizational forms: on communities, crowds, and new hybrids

Abstract In this article, I examine collaborative organizational forms in terms of their institutional properties and the mechanisms by which they solve the universal problems of organizing. Based on three ideal forms—markets, hierarchies, and communities—I propose a framework for analyzing and mapping organizational forms. The framework expands our understanding of the ideal forms and derives a set of analytically distinct hybrids at the intersection of the ideal types. The framework also specifies the main conditions that drive organizations to change form and move toward another hybrid or ideal form. The theoretical review of collaborative organizational forms is illustrated and informed by three empirical cases of new forms within the domains of drug discovery, software development, as well as professional services. Further, I discuss plural forms and the role of hierarchy in collaborative forms. Finally, I outline implications for research and practice in terms of comparative analysis of organizational forms, the role of crowds, as well as the interplay between new technologies and new organizational forms