Among 16,901 eligible patients, SGLT2i users experienced fibrosis progression at a rate of 3.46/100 person-years.
SGLT2i use was linked to a lower risk of fibrosis progression compared to DPP-4 inhibitors, with a hazard ratio of 0.78.
The progression to advanced fibrosis was confirmed on at least two occasions within one year for patients with and T2DM.
No significant difference in the incidence of major adverse liver outcomes was found between SGLT2i and DPP-4i users.
Subgroup analyses suggested consistent associations in patients using metformin, statins, and aspirin.
Simplified
BACKGROUND/AIMS: (MASLD) is a growing cause of cirrhosis and its complications. Given its close association with type 2 diabetes mellitus (T2DM), evaluating whether (SGLT2is) can mitigate the progression of liver fibrosis is clinically important. We examined the association between SGLT2i use and liver fibrosis progression in patients diagnosed with MASLD and T2DM.
METHODS: We conducted a target trial emulation study using a retrospective, active comparator new-user design among adults with MASLD, T2DM, and low-to-intermediate Fibrosis-4 (FIB-4≤2.67) scores who initiated treatment with either SGLT2is or (DPP-4is) at Mass General Brigham or Asan Medical Center from 2013 to 2023. The primary outcome was the progression to advanced fibrosis (FIB-4>2.67), confirmed on ≥2 occasions within 1 year. The secondary outcome was the development of major adverse liver outcomes (MALO), including incident cirrhosis, decompensation events, hepatocellular carcinoma, or liver transplantation.
RESULTS: Among 16,901 eligible patients, 2,571 propensity score-matched pairs were identified with balanced baseline characteristics. During follow-up (median, 3.7 years), fibrosis progression occurred at a rate of 3.46/100 personyears in SGLT2i users and 4.44 in DPP4i users. SGLT2i use was associated with a lower risk of fibrosis progression (HR 0.78, 95% CI 0.67-0.89; P<0.001). No significant difference in MALO incidence was observed. Subgroup analyses showed a consistent association among users of metformin, statins, and aspirin.
CONCLUSIONS: SGLT2i use was associated with reduced risk of fibrotic progression compared to DPP4i use in adults with MASLD and T2DM.
Key numbers
3.46 per 100 person-years
Fibrosis Progression Rate
Rate of fibrosis progression in SGLT2i users
0.78
Hazard Ratio for Fibrosis Progression
Hazard ratio comparing SGLT2i vs. DPP-4i users
4.44 per 100 person-years
Fibrosis Progression Rate in DPP-4i Users
Rate of fibrosis progression in DPP-4i users
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