Efficacy and safety of dapagliflozin compared to pioglitazone in diabetic and non-diabetic patients with non-alcoholic steatohepatitis: A randomized clinical trial - 06/02/25
, Abdulmoneim Adel b , Maggie M. Abbassi a , Doaa H. Abdelaziz c , Mohamed Hassany b , Maissa El Raziky d , Nirmeen A. Sabry a Highlights |
Compared to pioglitazone.
• | Dapagliflozin showed comparable histological effects in all NASH patients. |
• | Dapagliflozin exhibited significant superior benefits on anthropometric measures, metabolic profile and QOL in both non-diabetic and diabetic patients. |
• | Dapagliflozin was significantly more superior biochemically in diabetics while more superior on the level of IR, steatosis and fibrosis in non-diabetics. |
Abstract |
Background |
Non-alcoholic steatohepatitis (NASH) is a serious end-stage spectrum of non-alcoholic fatty liver disease (NAFLD) with associated high risk of hepatic and extrahepatic complications. Several studies showed the significant beneficial effect of dapagliflozin on body composition, hepatic and metabolic parameters on NAFLD/NASH patients. The study aimed to investigate the efficacy and safety of dapagliflozin in both diabetic and non-diabetic biopsy-proven NASH patients; compared to pioglitazone.
Methods |
This was a four-group, prospective, randomized, parallel, open label study in which 100 biopsy-proven NASH patients were selected, stratified to diabetics and non-diabetics and randomized with 1:1 allocation to either 30 mg pioglitazone or 10 mg dapagliflozin, once daily for 24 weeks. Histological evaluation, anthropometric measures, hepatic, metabolic biochemical markers, fibrosis non-invasive markers, quality of life (QOL) and medications adverse events were examined.
Results |
Dapagliflozin showed a comparable histological effect to pioglitazone in both diabetic and non-diabetic patients (P>0.05). As assessed by transient elastography, it also showed a comparable effect on liver fibrosis grade improvement from baseline in diabetics (P=0.287) versus a significant superiority in non-diabetics (P=0.018). Dapagliflozin showed a significant superiority in all anthropometric measures (P<0.001) and QOL (P<0.05) among both diabetics and non-diabetics. There was a significant interaction between interventions and diabetes status on change from baseline of hepatic and metabolic panel collectively (P=0.023) in favor to dapagliflozin among diabetics.
Conclusion |
Compared to pioglitazone, dapagliflozin had a comparable effect histologically, superior effect biochemically among diabetics and superior effect on liver fibrosis, steatosis and insulin resistance among non-diabetics.
Trial Registration |
The study was registered on clinicaltrials.gov, identifier number NCT05254626.
Le texte complet de cet article est disponible en PDF.Keywords : Dapagliflozin, Pioglitazone, Biopsy-proven, NASH, Diabetics, Non-diabetics
Abbreviations : AEs, ALP, ALT, AST, BMI, CAP, CBC, CLDQ, DD, DM, DND, FBG, FDA, FIB-4, GGT, Hb, HbA1C, HDL, HOMA-IR, kPa, LDL, LSM, NAFLD, NAS, NASH CRN, NFS, NHTMRI, MAFLD, MASH, MASLD, PD, PDFF, PND, QOL, RCTs, RM-ANOVA, SCr, SGLT2, SPSS, TC, TE, TGs, TSH, WC
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Vol 49 - N° 3
Article 102543- mars 2025 Retour au numéro
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