Guidelines recommend use of the FIB-4 score to assess risk of advanced fibrosis in all patients with type 2 diabetes. It remains uncertain if there is an additional value to add information on number of metabolic syndrome (MetS) traits to FIB-4 to improve risk prediction of major adverse liver outcomes (MALO).

Patients with type 2 diabetes in Stockholm without known liver disease were identified from national registers during 1998-2020. Patients with data available to calculate FIB-4 were included. MetS traits included hypertension, low HDL, hypertriglyceridemia, obesity, and albuminuria, in addition to type 2 diabetes. MALO:s were identified from national registers until October 31, 2020. Data were analysed using Cox regression models.

In total, 309 patients (1.34%) of 23,070 patients (median age: 65; 58% male), developed MALO over a median follow-up of 5.1 years. The rate of MALO increased with increasing numbers of MetS traits at baseline (aHR=1.12 per added trait, 95% CI=1.01-1.25). Compared to patients with low FIB-4, patients with intermediate or high FIB-4 had a higher rate of MALO (aHR=2.82, 95% CI=2.10-3.78, and aHR=9.60, 95% CI=7.20-12.80), respectively. There was no significant interaction effect between number of MetS traits and FIB-4 risk groups on the risk of MALO, and a modest increase in C-index when adding MetS traits to FIB-4 risk groups.

Additional metabolic syndrome traits increase the rate of progression to MALO in patients with type 2 diabetes independent of FIB-4 but add little to risk prediction on top of FIB-4.