Abstract
Aim
To assess the efficacy of sodium–glucose cotransporter-2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptors agonist (GLP-1RA) therapy on liver steatosis measured by fatty liver index (FLI) and hepatic steatosis index (HSI) at 26 weeks in outpatients with diabetes and obesity.
Methods
Observational, prospective, multicenter study. Patients with steatosis determined by FLI (values <30 rule out and >60 indicate steatosis) and HIS (values <30 rule out and >36 indicate steatosis) who received combination therapy were included. Patients were stratified into three groups according to the sequential order of treatment. We used robust statistical methods.
Results
In our final report we included 174 patients (58.6% males), mean age 61.9 (10) years. Baseline body mass index, waist circumference and weight were 36.5 (6.8) kg/m2, 117.5 (15.1) cm and 99.4 (20.5) kg, respectively. One hundred percent of patients had altered biomarkers of fatty liver scores (FLI 96 [13] and HSI 49.2 [8.5]). At 26 weeks, significant reductions in FLI (−4.5 [95% CI 3.5–5.9] p < .001) and HSI (−2.4 [95% CI 1.6–3.2] p < .001) were found in the total sample and pre-specified treatment and FLI cut-off point subgroups.
Conclusion
Our results show a beneficial effect of the combination of GLP-1RAs plus SGLT2is on liver steatosis that goes beyond glucose control, and it is related mainly to weight loss, a decline in biomarkers and reductions in abdominal circumference. For many patients, early detection is essential to improving outcomes in NAFLD and could allow us to select the most efficient treatment options.
Transparency
Declaration of funding
This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.
Declaration of financial/other relationships
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Data availability statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Researchers in the GLP-1RA–SGLT2i group: Alonso Peña Javier, Arévalo Lorido José Carlos, Carabantes Rueda Juan Jesús, Carrasco Sánchez Francisco Javier, Carretero Gómez Juana, Casas Rojo José Manuel, Ena Muñoz Javier, García de Lucas Dolores, Gómez Huelgas Ricardo, Inglada Galiana Luis, León Jimenez David, Mateos Polo Lourdes, Mediavilla García, Juan Diego, Moya Mateo Eva, Muñoz Rivas Nuria, Parga Menéndez Manjón Carmen, Seguí Ripoll Jose Miguel, Suárez Tembra Manuel, Torres do Rego Ana, Varela Aguilar José Manuel.
Author contributions
All authors contributed to the study’s conception and design. Data collection was performed by the researcher group. Material preparation and analysis were performed by J.C.G. and J.C.A.L. The first draft of the manuscript was written by J.C.G. and J.E., and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
Acknowledgements
Editorial assistance in the preparation of this article was provided by Claire Conrad of Conrad translations (https://conradtranslations.com/es/). The authors wish to acknowledge the Diabetes, Obesity and Nutrition working group of the Spanish Society of Internal Medicine (SEMI) for its constant support and dedication and Sergio Carretero Gómez (www.dualpixel.es) for their help in making the images.