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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. |
- Province, M. A., et al.
(författare)
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CYP2D6 Genotype and Adjuvant Tamoxifen : Meta-Analysis of Heterogeneous Study Populations
- 2014
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Ingår i: Clinical Pharmacology and Therapeutics. - New York, USA : Nature Publishing Group. - 0009-9236 .- 1532-6535. ; 95:2, s. 216-227
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Tidskriftsartikel (refereegranskat)abstract
- The International Tamoxifen Pharmacogenomics Consortium was established to address the controversy regarding cytochrome P450 2D6 (CYP2D6) status and clinical outcomes in tamoxifen therapy. We performed a meta-analysis on data from 4,973 tamoxifen-treated patients (12 globally distributed sites). Using strict eligibility requirements (postmenopausal women with estrogen receptor-positive breast cancer, receiving 20 mg/day tamoxifen for 5 years, criterion 1), CYP2D6 poor metabolizer status was associated with poorer invasive disease-free survival (IDFS: hazard ratio = 1.25; 95% confidence interval = 1.06, 1.47; P = 0.009). However, CYP2D6 status was not statistically significant when tamoxifen duration, menopausal status, and annual follow-up were not specified (criterion 2, n = 2,443; P = 0.25) or when no exclusions were applied (criterion 3, n = 4,935; P = 0.38). Although CYP2D6 is a strong predictor of IDFS using strict inclusion criteria, because the results are not robust to inclusion criteria (these were not defined a priori), prospective studies are necessary to fully establish the value of CYP2D6 genotyping in tamoxifen therapy.
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| 4. |
- Whaley, B, et al.
(författare)
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Using clinical cascades to measure health facilities' obstetric emergency readiness: testing the cascade model using cross-sectional facility data in East Africa
- 2022
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 12:4, s. e057954-
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Tidskriftsartikel (refereegranskat)abstract
- Globally, hundreds of women die daily from preventable pregnancy-related causes, with the greatest burden in sub-Saharan Africa. Five key emergencies—bleeding, infections, high blood pressure, delivery complications and unsafe abortions—account for nearly 75% of these obstetric deaths. Skilled clinicians with strategic supplies could prevent most deaths. In this study, we (1) measured facility readiness to manage common obstetric emergencies using the clinical cascades and signal function tracers; (2) compared these readiness estimates by facility characteristics; and (3) measured cascading drop-offs in resources.DesignA facility-based cross-sectional analysis of resources for common obstetric emergencies.SettingData were collected in 2016 from 23 hospitals (10 designated comprehensive emergency obstetric care (CEmOC) facilities) in Migori County, western Kenya, and Busoga Region, eastern Uganda, in the Preterm Birth Initiative study in East Africa. Baseline data were used to estimate a facility’s readiness to manage common obstetric emergencies using signal function tracers and the clinical cascade model. We compared emergency readiness using the proportion of facilities with tracers (signal functions) and the proportion with resources for identifying and treating the emergency (cascade stages 1 and 2).ResultsThe signal functions overestimated practical emergency readiness by 23 percentage points across five emergencies. Only 42% of CEmOC-designated facilities could perform basic emergency obstetric care. Across the three stages of care (identify, treat and monitor-modify) for five emergencies, there was a 28% pooled mean drop-off in readiness. Across emergencies, the largest drop-off occurred in the treatment stage. Patterns of drop-off remained largely consistent across facility characteristics.ConclusionsAccurate measurement of obstetric emergency readiness is a prerequisite for strengthening facilities’ capacity to manage common emergencies. The cascades offer stepwise, emergency-specific readiness estimates designed to guide targeted maternal survival policies and programmes.Trial registration numberNCT03112018.
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