BACKGROUND: The observational, real-world evidence FLIEDER study aimed to describe patient clinical characteristics and investigate clinical outcomes in non-diabetic patients with chronic kidney disease (CKD) using data collected from routine clinical practice in the United States. METHODS: Between 1 January, 2008-31 December, 2018, individuals aged ≥ 18 years, with non-diabetic, stage 3-4 CKD were indexed in the Optum® Clinformatics® Data Mart US healthcare claims database using International Classification of Diseases-9/10 codes for CKD or by laboratory values (estimated glomerular filtration rate [eGFR] 15-59 mL/min/1.73 m2). The primary outcomes were hospitalization for heart failure, a composite kidney outcome of end-stage kidney disease/kidney failure/need for dialysis and worsening of CKD stage from baseline. The effects of the intercurrent events of a sustained post-baseline decline in eGFR ≥ 30%, ≥ 40%, and ≥ 57% on the subsequent risk of the primary outcomes were also assessed. RESULTS: In the main study cohort (N = 504,924), median age was 75.0 years, and 60.5% were female. Most patients (94.7%) had stage 3 CKD at index. Incidence rates for hospitalization for heart failure, the composite kidney outcome, and worsening of CKD stage from baseline were 4.0, 10.3, and 4.4 events/100 patient-years, respectively. The intercurrent event analysis demonstrated that a relative decline in kidney function from baseline significantly increased the risk of cardiorenal events. CONCLUSIONS: This real-world study highlights that patients with non-diabetic CKD are at high risk of serious adverse clinical outcomes, and that this risk is amplified in patients who experienced greater post-baseline eGFR decline.
BACKGROUND: The observational, real-world evidence FLIEDER study aimed to describe patient clinical characteristics and investigate clinical outcomes in non-diabetic patients with chronic kidney disease (CKD) using data collected from routine clinical practice in the United States. METHODS: Between 1 January, 2008-31 December, 2018, individuals aged ≥ 18 years, with non-diabetic, stage 3-4 CKD were indexed in the Optum® Clinformatics® Data Mart US healthcare claims database using International Classification of Diseases-9/10 codes for CKD or by laboratory values (estimated glomerular filtration rate [eGFR] 15-59 mL/min/1.73 m2). The primary outcomes were hospitalization for heart failure, a composite kidney outcome of end-stage kidney disease/kidney failure/need for dialysis and worsening of CKD stage from baseline. The effects of the intercurrent events of a sustained post-baseline decline in eGFR ≥ 30%, ≥ 40%, and ≥ 57% on the subsequent risk of the primary outcomes were also assessed. RESULTS: In the main study cohort (N = 504,924), median age was 75.0 years, and 60.5% were female. Most patients (94.7%) had stage 3 CKD at index. Incidence rates for hospitalization for heart failure, the composite kidney outcome, and worsening of CKD stage from baseline were 4.0, 10.3, and 4.4 events/100 patient-years, respectively. The intercurrent event analysis demonstrated that a relative decline in kidney function from baseline significantly increased the risk of cardiorenal events. CONCLUSIONS: This real-world study highlights that patients with non-diabetic CKD are at high risk of serious adverse clinical outcomes, and that this risk is amplified in patients who experienced greater post-baseline eGFR decline.
Authors: E J Lewis; L G Hunsicker; W R Clarke; T Berl; M A Pohl; J B Lewis; E Ritz; R C Atkins; R Rohde; I Raz Journal: N Engl J Med Date: 2001-09-20 Impact factor: 91.245
Authors: Kai-Uwe Eckardt; Barbara Bärthlein; Seema Baid-Agrawal; Andreas Beck; Martin Busch; Frank Eitner; Arif B Ekici; Jürgen Floege; Olaf Gefeller; Hermann Haller; Robert Hilge; Karl F Hilgers; Jan T Kielstein; Vera Krane; Anna Köttgen; Florian Kronenberg; Peter Oefner; Hans-Ulrich Prokosch; André Reis; Matthias Schmid; Elke Schaeffner; Ulla T Schultheiss; Susanne A Seuchter; Thomas Sitter; Claudia Sommerer; Gerd Walz; Christoph Wanner; Gunter Wolf; Martin Zeier; Stephanie Titze Journal: Nephrol Dial Transplant Date: 2011-08-22 Impact factor: 5.992
Authors: B M Brenner; M E Cooper; D de Zeeuw; W F Keane; W E Mitch; H H Parving; G Remuzzi; S M Snapinn; Z Zhang; S Shahinfar Journal: N Engl J Med Date: 2001-09-20 Impact factor: 91.245
Authors: Andrew S Levey; Paul E de Jong; Josef Coresh; Meguid El Nahas; Brad C Astor; Kunihiro Matsushita; Ron T Gansevoort; Bertram L Kasiske; Kai-Uwe Eckardt Journal: Kidney Int Date: 2010-12-08 Impact factor: 10.612
Authors: Kyle J Foreman; Neal Marquez; Andrew Dolgert; Kai Fukutaki; Nancy Fullman; Madeline McGaughey; Martin A Pletcher; Amanda E Smith; Kendrick Tang; Chun-Wei Yuan; Jonathan C Brown; Joseph Friedman; Jiawei He; Kyle R Heuton; Mollie Holmberg; Disha J Patel; Patrick Reidy; Austin Carter; Kelly Cercy; Abigail Chapin; Dirk Douwes-Schultz; Tahvi Frank; Falko Goettsch; Patrick Y Liu; Vishnu Nandakumar; Marissa B Reitsma; Vince Reuter; Nafis Sadat; Reed J D Sorensen; Vinay Srinivasan; Rachel L Updike; Hunter York; Alan D Lopez; Rafael Lozano; Stephen S Lim; Ali H Mokdad; Stein Emil Vollset; Christopher J L Murray Journal: Lancet Date: 2018-10-16 Impact factor: 79.321