Elevated FIB-4 index as a risk marker within the KDIGO framework in patients with type 2 diabetes and hypertension
Hongmei Fu1,2, Chengzhi Xing2, Hengye Wang2
1Medical Department 1, Friedrich-Alexander-Universitat Erlangen-Nuremberg, Erlangen, Germany.
Insights
The Fibrosis-4 (FIB-4) index identifies patients with type 2 diabetes and hypertension at higher risk for chronic kidney disease (CKD) and vascular complications, even within low-risk KDIGO categories. FIB-4 complements existing KDIGO guidelines for better CKD risk stratification.
Area of Science:
- Nephrology
- Hepatology
- Cardiology
Background:
- Chronic kidney disease (CKD) management guidelines, such as KDIGO, stratify risk but may not capture all heterogeneous outcomes.
- Hypertension and type 2 diabetes mellitus (T2DM) are primary CKD drivers, often co-occurring with hepatic fibrosis.
- The Fibrosis-4 (FIB-4) index, a noninvasive marker for hepatic fibrosis, may offer additional risk prediction beyond current KDIGO stratification.
Purpose of the Study:
- To investigate if the FIB-4 index can identify residual risk in patients with T2DM and hypertension beyond KDIGO risk stratification.
- To assess the association of FIB-4 with KDIGO high/very high risk categories and CKD prevalence.
- To explore FIB-4's role in identifying vascular comorbidity burden within different KDIGO risk strata.
Main Methods:
- A cross-sectional study involving 1208 patients with T2DM and hypertension.
- FIB-4 index dichotomized at 1.3; primary outcome: KDIGO high/very high risk (3-4); secondary outcome: CKD (eGFR <60 mL/min/1.73 m² and/or ACR ≥30 mg/g).
- Statistical analyses included multivariable logistic regression, restricted cubic spline analysis, and stratified analyses.
Main Results:
- Elevated FIB-4 (>1.3) was independently associated with KDIGO 3-4 risk (OR 1.57) and CKD (OR 1.51) after multivariable adjustment.
- These associations persisted even when patients met BMI and LDL cholesterol targets.
- Within KDIGO low-risk groups, higher FIB-4 correlated with increased vascular comorbidities (p-trend<0.01), with a non-linear relationship and threshold effect around 1.3.
Conclusions:
- Elevated FIB-4 is an independent predictor of KDIGO 3-4 risk and CKD in patients with T2DM and hypertension.
- FIB-4 identifies increased vascular comorbidity burden, particularly within lower KDIGO risk categories.
- The FIB-4 index can serve as a valuable complementary tool for risk stratification in CKD management within the KDIGO framework.
Background And Aims:
The Kidney Disease: Improving Global Outcomes (KDIGO) 2024 guideline recommends risk stratification for chronic kidney disease (CKD) management; however, patients within the same KDIGO category may still experience heterogeneous outcomes. Hypertension and type 2 diabetes mellitus (T2DM) are predominant causes of CKD, and hepatic fibrosis is highly prevalent in this population, but not integrated into current KDIGO risk assessment. The Fibrosis-4 (FIB-4) index, a widely validated noninvasive marker of hepatic fibrosis, may capture residual risk not reflected by KDIGO stratification. This study aims to explore whether FIB-4 can identify residual risk beyond KDIGO stratification in patients with T2DM and hypertension.
Methods:
This cross-sectional study included 1208 patients with T2DM and hypertension. FIB-4 was dichotomized at 1.3 based on established guidelines. The primary outcome was KDIGO high/very high risk (categories 3-4). The secondary outcome was CKD, defined as an estimated glomerular filtration rate <60 mL/min/1.73 m² and/or albumin-to-creatinine ratio ≥30 mg/g. Multivariable logistic regression, restricted cubic spline analysis, and stratified analyses were conducted.
Results:
Among 1208 patients (mean age 58.3 years; 60.1% male), 514 (42.5%) had FIB-4>1.3, 286 (23.7%) were classified as KDIGO 3-4, and 588 (48.7%) met criteria for CKD. After multivariable adjustment, FIB-4>1.3 was independently associated with both KDIGO 3-4 (OR 1.57, 95% CI 1.12 to 2.19, p=0.008) and CKD (OR 1.51, 95% CI 1.14 to 2.01, p=0.004). In stratified analyses, these associations persisted among patients achieving body mass index/low-density lipoprotein cholesterol targets, although statistical power was limited for KDIGO 3-4. Within KDIGO low-risk categories, elevated FIB-4 was associated with a significantly higher prevalence of vascular comorbidities (p value for trend<0.01 for all). Restricted cubic spline modeling demonstrated a non-linear relationship, with a threshold effect at approximately 1.3 (p value for non-linearity<0.001 for KDIGO 3-4; p=0.010 for CKD).
Conclusions:
Elevated FIB-4 is independently associated with KDIGO 3-4 and CKD, and identifies patients with higher vascular comorbidity burden even within KDIGO low-risk categories. FIB-4 may serve as a complementary risk stratification marker within the KDIGO framework for patients with T2DM and hypertension.
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