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

A reassessment of the International Study Group criteria for the diagnosis (classification) of Behcet's syndrome

Objective Patients with ulcerative colitis (UC) and Crohn's disease (CD) were not represented in the diseased controls group that had been utilised in the development of the International Study Group (ISG) criteria for the diagnosis of Behcet's syndrome (BS). Having similar features, both of these conditions can pose problems in the differential diagnosis of BS. Moreover there has been a recent awareness of coexistence of BS and familial Mediterranean fever (FMF). The aim of this study was to reassess the performance of ISG criteria among patients with BS and other rheumatological conditions, specifically including those with CD, UC, and FM

OBSERVER VARIATION IN GRADING SACROILIAC RADIOGRAPHS MIGHT BE A CAUSE OF SACROILIITIS REPORTED IN CERTAIN DISEASE STATES

Radiological sacroiliitis in Behçet's syndrome (BS) has been a subject of controversy. We have examined pelvic radiographs of 38 patients with BS and 28 age and sex matched controls which we reported previously, and also 17 with ankylosing spondylitis (AS), 27 with non-renal familial Mediterranean fever (FMF), and 33 with primary osteoarthrosis (OA). Initially, five observers assessed radiographs on two different occasions according to the New York criteria for sacroiliitis in a blind protocol. Later, three of them examined the various possible abnormalities of the sacroiliac (SI) joints after training sessions. Although the inter- and intraobserver variation was quite high, all observers found the expected changes in patients with AS. The abnormalities detected in the other diseases were either mild, inconsistent, or both. Erosions were confined to patients with AS, and osteophytes and glenoid sulci to patients with OA. We conclude that high observer variation in interpreting a film of the anteroposterior (AP) view of the pelvis for sacroiliitis may be a major cause of reported 'sacroiliitis' in BS and FMF

Evaluation of classification criteria for juvenile-onset spondyloarthropathies

Objective: The aim of this study was to investigate the adequacy of the following criteria for the classification of juvenile-onset spondyloarthropathies (JSpA): European Spondyloarthropathy Study Group criteria ( ESSGCr) and Amor criteria (ACr) ( proposed for adult SpA), Garmisch-Partenkirchen ( G-PCr), seronegative enthesopathy and arthropathy syndrome (SEACr), and atypical spondyloarthropathies classification criteria (ASpCr) ( proposed for JSpA). Methods: Sixty-two patients with JSpA ( 48 male and 14 female) and 64 with juvenile idiopathic arthritis ( 27 male and 37 female) ( excluding enthesitis-related and psoriatic arthritis) were enrolled in the study group. Twenty-nine of the patients with JSpA were diagnosed with definite JSpA and the remaining 35 with undifferentiated JSpA. One hundred six patients in the study group were evaluated by one investigator, who was unaware of the diagnosis, according to the following: ESSGCr, ACr, GPCr, ASpCr, and SEACr. Results: Analysis of the patients diagnosed with JSpA showed 83.9%, 82.3%, 95.2%, 61.3%, and 62.9% sensitivity and 87.5%, 95.3%, 78.1%, 98.4%, and 92.2% specificity for the ESSGCr, ACr, G- PCr, ASpCr, and SEACr sets, respectively. Conclusion: None of the criteria evaluated above is sufficient for the classification of JSpA. There is a definite need for a new set of criteria with high specificity and sensitivity for early recognition and classification

JUVENILE CHRONIC ARTHRITIS IN A TURKISH POPULATION

The clinical characteristics of 147 Turkish patients with juvenile chronic arthritis seen between 1980 and 1988 were analyzed retrospectively. There was a male predominance (1.3:1), and a relatively low occurrence of early onset pauciarticular disease (16%), chronic anterior uveitis (7%) and positive antinuclear antigens (6%), but a high incidence of secondary amyloidosis (10%) was seen