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- Ruilope, LM, et al.
(författare)
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Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
- 2019
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Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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Tidskriftsartikel (refereegranskat)abstract
- <b><i>Background:</i></b> 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. <b><i>Patients and</i></b> <b><i>Methods:</i></b> 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<sup>2</sup> 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 α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. <b><i>Conclusions:</i></b> 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.
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- Choi, B., et al.
(författare)
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Cross-language differential item functioning of the job content questionnaire among European countries: the JACE study
- 2009
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Ingår i: International Journal of Behavioral Medicine. - : Springer Science and Business Media LLC. - 1532-7558 .- 1070-5503. ; 16:2, s. 136-47
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Little is known about cross-language measurement equivalence of the job content questionnaire (JCQ) PURPOSE: The purposes of this study were to assess the extent of cross-language differential item functioning (DIF) of the 27 JCQ items in six languages (French, Dutch, Belgian-French, Belgian-Dutch (Flemish), Italian, and Swedish) from six European research centers and to test whether its effects on the scale-level mean comparisons among the centers were substantial or not. METHOD: A partial gamma coefficient method was used for statistical DIF analyses where the Flemish JCQ was the reference for other language versions. Additionally, equivalence between the Flemish and Dutch translations was subjected to a judgmental review. RESULTS: On average, 36% to 39% of the total tested items appeared to be cross-language DIF items in the statistical analyses. The judgmental review indicated that half of the DIF items may be associated with translation difference. The impacts of the DIF items on the mean comparisons of the JCQ scales between the centers were non-trivial: underestimated skill discretion (Milan), underestimated decision authority (Leiden), underestimated psychological demands (Milan women), and incomparable coworker support (Gothenburg 95). CONCLUSION: Cross-language DIF of the JCQ among European countries should be considered in international comparative studies on psychosocial job hazards using JCQ scales.
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- Kivimäki, Mika, et al.
(författare)
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Associations of job strain and lifestyle risk factors with risk of coronary artery disease : a meta-analysis of individual participant data
- 2013
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Ingår i: CMJA. Canadian Medical Association Journal. Onlineutg. Med tittel. - : CMA Joule Inc.. - 0820-3946 .- 1488-2329. ; 185:9, s. 763-769
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Tidskriftsartikel (refereegranskat)abstract
- Background: It is unclear whether a healthy lifestyle mitigates the adverse effects of job strain on coronary artery disease. We examined the associations of job strain and lifestyle risk factors with the risk of coronary artery disease.Methods: We pooled individual-level data from 7 cohort studies comprising 102 128 men and women who were free of existing coronary artery disease at baseline (1985–2000). Questionnaires were used to measure job strain (yes v. no) and 4 lifestyle risk factors: current smoking, physical inactivity, heavy drinking and obesity. We grouped participants into 3 lifestyle categories: healthy (no lifestyle risk factors), moderately unhealthy (1 risk factor) and unhealthy (2–4 risk factors). The primary outcome was incident coronary artery disease (defined as first nonfatal myocardial infarction or cardiac-related death).Results: There were 1086 incident events in 743 948 person-years at risk during a mean follow-up of 7.3 years. The risk of coronary artery disease among people who had an unhealthy lifestyle compared with those who had a healthy lifestyle (hazard ratio [HR] 2.55, 95% confidence interval [CI] 2.18–2.98; population attributable risk 26.4%) was higher than the risk among participants who had job strain compared with those who had no job strain (HR 1.25, 95% CI 1.06–1.47; population attributable risk 3.8%). The 10-year incidence of coronary artery disease among participants with job strain and a healthy lifestyle (14.7 per 1000) was 53% lower than the incidence among those with job strain and an unhealthy lifestyle (31.2 per 1000).Interpretation: The risk of coronary artery disease was highest among participants who reported job strain and an unhealthy lifestyle; those with job strain and a healthy lifestyle had half the rate of disease. A healthy lifestyle may substantially reduce disease risk among people with job strain.
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