Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: 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. Patients and Methods: 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(2) 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 alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: 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

Psychosocial Problems in People Living with Thalassemia: A Systematic Review

Background Thalassemia is a genetic disease that is inherited in families and has been designated as a global burden. Individuals living with thalassemia may experience impacts on their psychosocial well-being. However, there is a gap of limited study at the systematic review level regarding the extent to which psychosocial aspects contribute to the overall problems and burdens experienced by people living with thalassemia. Aim This study aimed to synthesize the evidence on psychosocial problems in people living with thalassemia to provide comprehensive insight. Methods The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline was used to guide this systematic review. All relevant empirical studies in the English language that assessed the variety of psychosocial aspects were included. A total of 1,466 articles were identified from PubMed, CINAHL, ProQuest, PsycINFO, Scopus, Web of Science, and Cochrane databases from those inceptions to 6 March 2023. 1,443 articles were excluded due to duplication, not thalassemia- or psychosocial-related, availability of full-text, and not including patients. Finally, 13 studies were included and assessed using Mixed Methods Appraisal Tool (MMAT) appraisal tools. This study is already registered in International Prospective Register of Systematic Reviews (CRD42023431082). Results This review analyzed 13 full-text studies conducted between 1993 and 2022. The MMAT quality assessment rated all 13 studies as high quality. The included studies used various designs, with six non-randomized quantitative studies, five descriptive quantitative studies, and two qualitative studies. The review summarizes each study's main findings, highlighting psychosocial problems and related outcomes, such as adherence and psychosocial morbidity, anxiety, educational and social impairment, coping style, internalizing and externalizing behaviors, and adaptive behaviors and family relationships. Discussion The available literature globally highlights the psychosocial challenges of people living with thalassemia, particularly those who require regular blood transfusions across different timeframes. Despite inconsistent definitions across studies, it is notable that patients with thalassemia major facing physical changes associated with facial defects and experience significant psychosocial issues related to self-image, social interactions, and relationships that influence quality of life