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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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| 2. |
- Chavatza, K, et al.
(författare)
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EULAR RECOMMENDATION-BASED QUALITY INDICATORS (QIS) FOR SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): ELABORATION, FINAL SET, PERFORMANCE AND INITIAL VALIDATION
- 2021
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Ingår i: ANNALS OF THE RHEUMATIC DISEASES. - : BMJ. - 0003-4967 .- 1468-2060. ; 80, s. 635-636
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Targets of therapy and quality of care are receiving increased attention in systemic lupus erythematosus (SLE).Objectives:To develop Quality Indicators (QIs) for the care of SLE patients based on the EULAR recommendations, and assess their performance.Methods:Using the published EULAR recommendations for SLE, we developed 44 candidate QIs. These were independently rated for validity and feasibility by 12 experts, analysed by a modified RAND/UCLA model and further scrutinized based on the scorings and expert opinion. (Fig.1) Adherence to the final set of QIs was tested in a cohort of 220 SLE patients combined with an assessment on its impact on disease outcomes such as flares, hospitalizations and organ damage.Results:The panel rated 18 QIs as valid and feasible. These involve diagnosis; disease and damage assessment; monitoring for lupus nephritis and drug toxicity; therapy and targets of therapy; fertility and pregnancy; and adjunct therapy (preventive measures for osteoporosis, vaccination, cardiovascular disease). On average, SLE patients received 54% (95%CI 52–56%) of the indicated care with adherence ranging from 41% for QIs related to monitoring to 88% for treatment-related QIs. Regarding targets of therapy, sustained remission or low disease activity were achieved in 27%, while 94% of patients received low-dose glucocorticoids, and 92% the recommended hydroxychloroquine dose. Dependent upon individual QI tested, adherence for lupus nephritis-related QIs was 88% for receiving appropriate adjunct therapy (ACE inhibitors) to 100% for being treated with the indicated immunosuppressive treatment. In contrast, adherence to QIs related to preventive measures and other adjunct therapies was moderate to low. Notably, patients who were eligible for cardiovascular risk modification, vaccination, and osteoporosis management received lower quality of care (40.5%, 47.7% and 45.5% respectively) while 91.4% had sunscreen protection. In reference to laboratory work-up and monitoring, complete laboratory work-up at diagnosis was performed in 48%, while disease activity and damage, were fully assessed only in 14.1% (in three consecutive visits) and 28.6% (annually) respectively, Similarly, reproductive health and pregnancy counselling adherence rates were modest estimated at 50% and 62% respectively. Higher adherence to the indicated care during follow-up (monitoring QIs) was associated with reduced risk for adverse outcomes during the last year of observation (OR 0.97, 95%CI 0.96-0.99). Patients who achieved sustained remission or LLDAS, exhibited fewer flares (OR=0.15, p-value<0.001) and damage accrual (OR=0.35, p-value<0.001). Of interest, patients who received low-dose of GCs or were appropriately vaccinated, had a lower risk of experiencing a flare (OR=0.23 and 0.46 respectively).Conclusion:A set of 18 QIs based on the EULAR recommendations for SLE was developed to be used towards improving care in SLE. Initial real-life data suggest variable degree of adherence with higher adherence resulting in reduced adverse outcomes.References:[1]Fanouriakis, et al., 2019 Update of the EULAR recommendations for the management of systemic lupus erythematosus. In Annals of the Rheumatic Diseases (Vol. 78, Issue 6, pp. 736–745). BMJ Publishing Group. https://doi.org/10.1136/annrheumdis-2019-215089.[2]Nikolopoulos, D., et al., Evolving phenotype of systemic lupus erythematosus in Caucasians: low incidence of lupus nephritis, high burden of neuropsychiatric disease and increased rates of late-onset lupus in the ‘Attikon’ cohort. Lupus, 29(5), 514–522. https://doi.org/10.1177/0961203320908932.Acknowledgements:This project has received funding from the European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation programme (grant agreement No 742390)Disclosure of Interests:None declared
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| 3. |
- Fanouriakis, Antonis, et al.
(författare)
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EULAR recommendations for the management of systemic lupus erythematosus : 2023 update
- 2024
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Ingår i: Annals of the Rheumatic Diseases. - : HighWire Press. - 0003-4967 .- 1468-2060. ; 83:1, s. 15-29
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To update the EULAR recommendations for the management of systemic lupus erythematosus (SLE) based on emerging new evidence.METHODS: An international Task Force formed the questions for the systematic literature reviews (January 2018-December 2022), followed by formulation and finalisation of the statements after a series of meetings. A predefined voting process was applied to each overarching principle and recommendation. Levels of evidence and strengths of recommendation were assigned, and participants finally provided their level of agreement with each item.RESULTS: The Task Force agreed on 5 overarching principles and 13 recommendations, concerning the use of hydroxychloroquine (HCQ), glucocorticoids (GC), immunosuppressive drugs (ISDs) (including methotrexate, mycophenolate, azathioprine, cyclophosphamide (CYC)), calcineurin inhibitors (CNIs, cyclosporine, tacrolimus, voclosporin) and biologics (belimumab, anifrolumab, rituximab). Advice is also provided on treatment strategies and targets of therapy, assessment of response, combination and sequential therapies, and tapering of therapy. HCQ is recommended for all patients with lupus at a target dose 5 mg/kg real body weight/day, considering the individual's risk for flares and retinal toxicity. GC are used as 'bridging therapy' during periods of disease activity; for maintenance treatment, they should be minimised to equal or less than 5 mg/day (prednisone equivalent) and, when possible, withdrawn. Prompt initiation of ISDs (methotrexate, azathioprine, mycophenolate) and/or biological agents (anifrolumab, belimumab) should be considered to control the disease and facilitate GC tapering/discontinuation. CYC and rituximab should be considered in organ-threatening and refractory disease, respectively. For active lupus nephritis, GC, mycophenolate or low-dose intravenous CYC are recommended as anchor drugs, and add-on therapy with belimumab or CNIs (voclosporin or tacrolimus) should be considered. Updated specific recommendations are also provided for cutaneous, neuropsychiatric and haematological disease, SLE-associated antiphospholipid syndrome, kidney protection, as well as preventative measures for infections, osteoporosis, cardiovascular disease.CONCLUSION: The updated recommendations provide consensus guidance on the management of SLE, combining evidence and expert opinion.
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