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- Ruilope, LM, et al.
(author)
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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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In: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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Journal article (peer-reviewed)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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| 2. |
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- 2019
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Journal article (peer-reviewed)
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| 4. |
- van den Besselaar, A. M. H. P., et al.
(author)
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International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain
- 2018
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In: Journal of Thrombosis and Haemostasis. - : WILEY. - 1538-7933 .- 1538-7836. ; 16:1, s. 142-149
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Journal article (peer-reviewed)abstract
- Background: The availability of International Standards for thromboplastin is essential for the calibration of routine reagents and hence the calculation of the International Normalized Ratio (INR). Stocks of the current Fourth International Standards are running low. Candidate replacement materials have been prepared. This article describes the calibration of the proposed Fifth International Standards for thromboplastin, rabbit, plain (coded RBT/16) and for thromboplastin, recombinant, human, plain (coded rTF/16). Methods: An international collaborative study was carried out for the assignment of International Sensitivity Indexes (ISIs) to the candidate materials, according to the World Health Organization (WHO) guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists. Results: Results were obtained from 20 laboratories. In several cases, deviations from the ISI calibration model were observed, but the average INR deviation attributabled to the model was not greater than 10%. Only valid ISI assessments were used to calculate the mean ISI for each candidate. The mean ISI for RBT/16 was 1.21 (between-laboratory coefficient of variation [CV]: 4.6%), and the mean ISI for rTF/16 was 1.11 (between-laboratory CV: 5.7%). Conclusions: The between-laboratory variation of the ISI for candidate material RBT/16 was similar to that of the Fourth International Standard (RBT/05), and the between-laboratory variation of the ISI for candidate material rTF/16 was slightly higher than that of the Fourth International Standard (rTF/09). The candidate materials have been accepted by WHO as the Fifth International Standards for thromboplastin, rabbit plain, and thromboplastin, recombinant, human, plain.
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| 5. |
- De Neve, Jan-Walter, et al.
(author)
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Antiretroviral therapy coverage associated with increased co-residence between older and working-age adults in Africa
- 2018
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In: AIDS. - 1473-5571. ; 32:14, s. 2051-2057
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To determine whether national antiretroviral therapy (ART) coverage is associated with changes in the living arrangements of older adults.DESIGN: Retrospective analysis using 103 nationally representative surveys from 28 African countries between 1991 and 2015.METHODS: The sample consisted of individuals aged at least 60 years. We investigated how three measures of living arrangements of older adults have changed with ART coverage: the number of older individuals living without working-age adults, the number of older individuals living with only dependent children (i.e. 'missing generation' households), and the number of working-age adults per household where an older individual lives.RESULTS: Our sample consisted of 297 331 older adults. An increase in ART coverage of 1% was associated with a 0.7 percentage point reduction (P < 0.001) in the probability of an older adult living without working-age adult and a 0.2 percentage point reduction (P = 0.005) in the probability of an older adult living in a 'missing generation' household. Increases in ART coverage were also associated with more working-age adults in households with at least one older adult. In our study countries, representing 75% (749 million) of the sub-Saharan population, an additional 103 000-358 000 older adults could be living with working-age adults as a result of increased ART coverage (1%).CONCLUSION: The scale-up of ART has likely led to substantial increases in co-residence between older and working-age adults in Africa. Returns to investments in HIV treatment will be too low, if the social benefits from these changes in living arrangements of older adults are not taken into account.
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| 6. |
- Karlsson, Omar, et al.
(author)
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Socioeconomic and gender inequalities in neonatal, postneonatal and child mortality in India : A repeated cross-sectional study, 2005-2016
- 2019
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In: Journal of Epidemiology and Community Health. - : BMJ. - 0143-005X .- 1470-2738. ; 73:7, s. 660-667
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Journal article (peer-reviewed)abstract
- Background: In India, excess female under-5 mortality is well documented. Under-5 mortality is also known to be patterned by socioeconomic factors. This study examines sex differentials and sex-specific wealth gradients in neonatal, postneonatal and child mortality in India. Methods: Repeated cross-sectional study of nationally representative samples of 298 955 children 0-60 months old from the National Family Health Surveys conducted in 2005-2006 and 2015-2016. The study used logistic regression models as well as Cox proportional hazards models. Results: Overall, boys had greater neonatal mortality than girls and the difference increased between 2005-2006 and 2015-2016. Girls had greater postneonatal and child mortality, but the difference decreased between the surveys and was not statistically significant for child mortality in 2015-2016. A negative wealth gradient was found for all mortality outcomes. Neonatal mortality was persistently greater for boys. Girls had higher child mortality than boys at low levels of wealth and greater postneonatal mortality over much of the wealth distribution. The wealth gradient in neonatal mortality increased between surveys. Females had a stronger wealth gradient than boys for child mortality. Conclusion: Not distinguishing between neonatal, postneonatal and child mortality masks important gender-specific and wealth-specific disparities in under-5 mortality in India. Substantial gains towards the Sustainable Development Goals can be made by combating neonatal mortality, especially at low levels of wealth. Although impressive improvements have been made in reducing the female disadvantage in postneonatal and child mortality, concerted engagements are necessary to eliminate the gender gap - especially in poor households and in north India.
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| 7. |
- Kobayashi, Lindsay C., et al.
(author)
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Education modifies the relationship between height and cognitive function in a cross-sectional population-based study of older adults in Rural South Africa
- 2019
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In: European Journal of Epidemiology. - : Springer. - 0393-2990 .- 1573-7284. ; 34:2, s. 131-139
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Journal article (peer-reviewed)abstract
- We aimed to estimate the relationship between height (a measure of early-life cumulative net nutrition) and later-life cognitive function among older rural South African adults, and whether education modified this relationship. Data were from baseline in-person interviews with 5059 adults40years in the population-based Health and Aging in Africa: A Longitudinal Study of an INDEPTH Community in South Africa (HAALSI) study in Agincourt sub-district, South Africa, in 2015. Linear regression was used to estimate the relationship between height quintile and latent cognitive function z-score (representing episodic memory, time orientation, and numeracy), with adjustment for life course covariates and a height-by-education interaction. Mean (SD) height was 162.7 (8.9) cm. Nearly half the sample had no formal education (46%; 2307/5059). Mean age- and sex-adjusted cognitive z-scores increased from -0.68 (95% CI: -0.76 to -0.61) in those with no education in the shortest height quintile to 0.62 (95% CI: 0.52-0.71) in those with at least 8years of education in the tallest height quintile. There was a linear height disparity in cognitive z-scores for those with no formal education (adjusted =0.10; 95% CI: 0.08-0.13 per height quintile), but no height disparity in cognitive z-scores in those with any level of education. Short stature is associated with poor cognitive function and may be a risk factor for cognitive impairment among older adults living in rural South Africa. The height disparity in cognitive function was negated for older adults who had any level of education.
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| 10. |
- Merlo, Juan, et al.
(author)
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General and specific contextual effects in multilevel regression analyses and their paradoxical relationship : A conceptual tutorial
- 2018
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In: SSM - Population Health. - : Elsevier. - 2352-8273. ; 5, s. 33-37
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Journal article (peer-reviewed)abstract
- To be relevant for public health, a context (e.g., neighborhood, school, hospital) should influence or affect the health status of the individuals included in it. The greater the influence of the shared context, the higher the correlation of subject outcomes within that context is likely to be. This intra-context or intra-class correlation is of substantive interest and has been used to quantify the magnitude of the general contextual effect (GCE). Furthermore, ignoring the intra-class correlation in a regression analysis results in spuriously narrow 95% confidence intervals around the estimated regression coefficients of the specific contextual variables entered as covariates and, thereby, overestimates the precision of the estimated specific contextual effects (SCEs). Multilevel regression analysis is an appropriate methodology for investigating both GCEs and SCEs. However, frequently researchers only report SCEs and disregard the study of the GCE, unaware that small GCEs lead to more precise estimates of SCEs so, paradoxically, the less relevant the context is, the easier it is to detect (and publish) small but "statistically significant" SCEs. We describe this paradoxical situation and encourage researchers performing multilevel regression analysis to consider simultaneously both the GCE and SCEs when interpreting contextual influences on individual health.
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