Medizinische Klinik und Poliklinik 1, Schwerpunkt Nephrologie, Universitätsklinik Würzburg, Würzburg, Germany.
MicroDiscovery GmbH, Berlin, Germany.
J Nephrol. 2023 Jan;36(1):45-54. doi: 10.1007/s40620-022-01340-x. Epub 2022 May 14.
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.
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 m). 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.
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.
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.
观察性、真实世界证据 FLIEDER 研究旨在使用美国常规临床实践中收集的数据,描述非糖尿病慢性肾脏病(CKD)患者的临床特征,并调查其临床结局。
2008 年 1 月 1 日至 2018 年 12 月 31 日期间,年龄≥18 岁的非糖尿病、CKD 3-4 期患者,通过国际疾病分类第 9/10 版 CKD 代码(CKD 或实验室值[eGFR]15-59mL/min/1.73m),在 Optum Clinformatics Data Mart 美国医疗保健索赔数据库中被索引。主要结局是心力衰竭住院、终末期肾病/肾衰竭/需要透析的肾脏复合结局以及从基线开始 CKD 阶段恶化。还评估了基线后 eGFR 持续下降≥30%、≥40%和≥57%等并发事件对主要结局随后风险的影响。
在主要研究队列(N=504924)中,中位年龄为 75.0 岁,60.5%为女性。大多数患者(94.7%)在索引时患有 3 期 CKD。心力衰竭住院、肾脏复合结局和 CKD 从基线恶化的发生率分别为 4.0、10.3 和 4.4 例/100 患者年。并发事件分析表明,肾功能从基线相对下降显著增加了心肾事件的风险。
这项真实世界研究表明,非糖尿病 CKD 患者发生严重不良临床结局的风险较高,而基线后 eGFR 下降较大的患者风险更高。