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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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| 4. |
- Borel-Derlon, A., et al.
(författare)
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Treatment of severe von Willebrand disease with a high-purity von Willebrand factor concentrate (Wilfactin (R)): a prospective study of 50 patients
- 2007
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Ingår i: Journal of Thrombosis and Haemostasis. - : Elsevier BV. - 1538-7933 .- 1538-7836. ; 5:6, s. 1115-1124
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Tidskriftsartikel (refereegranskat)abstract
- Background and objectives: A plasma-derived von Willebrand factor (VWF) concentrate with low factor VIII (FVIII) content was specifically developed to treat von Willebrand disease (VWD). Efficacy and safety were investigated by merging the results of two comparable protocols conducted prospectively in 5 European and 12 French centers. Methods and results: Fifty patients with clinically severe VWD (72% had VWF ristocetin cofactor activity less than 10 IU dL(-1) and 46% had FVIII < 20 IU dL(-1)) were treated with the concentrate as the only therapy, except for clinical situations requiring a priming dose of FVIII to rapidly correct an intrinsic coagulation defect. A total of 139 spontaneous bleeding episodes were treated; only 53 (38%) needed a concomitant FVIII dose. Outcome was excellent or good in 89% of the episodes. Forty-four patients underwent 108 surgical or invasive procedures. Outcome was excellent or good in 95 scheduled procedures (only VWF was infused) and 13 emergency procedures (a priming FVIII dose was co-administered with the first VWF infusion). There were no thrombotic complications and none of the 18 patients with type 3 VWD developed anti-VWF or anti-FVIII antibodies. Conclusions. This concentrate safely and effectively provides hemostasis in patients with clinically severe VWD.
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| 5. |
- Morawska, Lidia, et al.
(författare)
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COVID-19 and airborne transmission : science rejected, lives lost : can society do better?
- 2023
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Ingår i: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. - : Oxford University Press (OUP). - 1537-6591. ; 76:10, s. 1854-1859
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Tidskriftsartikel (refereegranskat)abstract
- This is an account that should be heard of an important struggle: the struggle of a large group of experts who came together at the beginning of the Covid-19 pandemic to warn the world about the risk of airborne transmission and the consequences of ignoring it. We alerted the World Health Organization (WHO) about the potential significance of the airborne transmission of SARS-CoV-2 and the urgent need to control it, but our concerns were dismissed. Here we describe how this happened and the consequences. We hope that by reporting this story, we can raise awareness of the importance of interdisciplinary collaboration and the need to be open to new evidence, and to prevent it from happening again. Acknowledgement of an issue and the emergence of new evidence related to it, is the first necessary step towards finding effective mitigation solutions.
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| 6. |
- Morawska, Lidia, et al.
(författare)
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How can airborne transmission of COVID-19 indoors be minimised?
- 2020
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Ingår i: Environment International. - : Elsevier BV. - 1873-6750 .- 0160-4120. ; 142
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Tidskriftsartikel (refereegranskat)abstract
- During the rapid rise in COVID-19 illnesses and deaths globally, and notwithstanding recommended precautions, questions are voiced about routes of transmission for this pandemic disease. Inhaling small airborne droplets is probable as a third route of infection, in addition to more widely recognized transmission via larger respiratory droplets and direct contact with infected people or contaminated surfaces. While uncertainties remain regarding the relative contributions of the different transmission pathways, we argue that existing evidence is sufficiently strong to warrant engineering controls targeting airborne transmission as part of an overall strategy to limit infection risk indoors. Appropriate building engineering controls include sufficient and effective ventilation, possibly enhanced by particle filtration and air disinfection, avoiding air recirculation and avoiding overcrowding. Often, such measures can be easily implemented and without much cost, but if only they are recognised as significant in contributing to infection control goals. We believe that the use of engineering controls in public buildings, including hospitals, shops, offices, schools, kindergartens, libraries, restaurants, cruise ships, elevators, conference rooms or public transport, in parallel with effective application of other controls (including isolation and quarantine, social distancing and hand hygiene), would be an additional important measure globally to reduce the likelihood of transmission and thereby protect healthcare workers, patients and the general public.
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| 7. |
- Morawska, Lidia, et al.
(författare)
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Mandating indoor air quality for public buildings : if some countries lead by example, standards may increasingly become normalized
- 2024
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Ingår i: Science. - 0036-8075. ; 383:6690, s. 1418-1420
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Tidskriftsartikel (refereegranskat)abstract
- People living in urban and industrialized societies, which are expanding globally, spend more than 90% of their time in the indoor environment, breathing indoor air (IA). Despite decades of research and advocacy, most countries do not have legislated indoor air quality (IAQ) performance standards for public spaces that address concentration levels of IA pollutants. Few building codes address operation, maintenance, and retrofitting, and most do not focus on airborne disease transmission. But the COVID-19 pandemic has made all levels of society, from community members to decision-makers, realize the importance of IAQ for human health, wellbeing, productivity, and learning. We propose that IAQ standards be mandatory for public spaces. Although enforcement of IAQ performance standards in homes is not possible, homes must be designed and equipped so that they could meet the standards.For the past two decades, scientists have called for national IAQ standards and laws to be established (2), but so far, little action has been taken. The approach to IA contrasts sharply with outdoor air, for which quality is regulated and monitored and compliance with regulations is enforced. The World Health Organization (WHO) Global Air Quality Guidelines (AQG) published in 2021 provide recommendations for concentration levels of six pollutants and their averaging times (PM2.5, PM10, NO2, SO2, CO, and O3) and apply to both outdoor air and IA (3).In cases for which IAQ standard and guideline values were established by national or association working groups, the outcomes were inconsistent; often the criteria for the same parameter differed by orders of magnitude. The reasons cited for limited progress include different criteria in the selection of the critical study, in the starting point, and in the derivation procedure; the complex political, social, and legislative situation regarding IAQ; the lack of an open, systematic, and harmonized approach; and that establishing an IAQ standard is always the result of a compromise between scientific knowledge and political will. Because of the heterogenous landscape of approaches needed, such barriers remain intact despite the considerable IAQ research and evidence base developed over the past decades.
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