Document Type : Original Article
Authors
1
Diabetes and Endocrinology unit, Internal medicine department, Faculty of Medicine, Minia University, Minia, Egypt
2
Clinical Pharmacy Department, Faculty of Pharmacy, Sohag University, Sohag, Egypt
3
Clinical Pharmacology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt. & Department of Pharmacy Practice, Pharmacy Program, Batterjee Medical College, Jeddah 21442, Saudi Arabia
4
Radiology Department-Faculty of medicine- Minia University, Minia, Egypt
5
Clinical Pathology Department -faculty of medicine -Minia University, Minia, Egypt
6
Critical care and internal medicine, Internal medicine department, Faculty of Medicine, Minia University, Minia, Egypt
7
Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt
Abstract
Background: Pentoxifylline (PTX) has been proven to reduce hepatic steatosis in animal models; however, data regarding its safety and efficacy in type-2 diabetics (T2D) with nonalcoholic fatty liver disease (NAFLD) are rare. Aim: Determine the effects of PTX in reducing liver fat content (LFC; %) in T2D patients with NAFLD in various disease states. Methods: 187 T2D subjects with NAFLD were randomized to receive either Pentoxifylline 800 mg (PTX group) or standard T2D care only (control group) for 24 weeks. The primary outcomes included changes in LFC (%) as measured by magnetic resonance imaging-derived proton density fat-fraction technique (MRI-PDFF) and the calculation of a fibrosis score (NFS). Results: PTX significantly reduced LFC (%) more than the control group (-8.18 vs. -1.87; P< 0.0001). Only the PTX group significantly reduced the NFS score (-1.16; P<0.0001). The PTX group showed significant LFC changes in liver segments II (-9.77; P< 0.0001), IVb (-9.51; P< 0.0001), and VI (-9.13; P< 0.0001); however, the control group achieved significant LFC changes in liver segments III (-2.57; P= 0.02) and VI (-2.22; P= 0.04). In subgroup analysis, PTX showed comparable efficacy in decreasing LFC in different fibrosis scores, gender, and BMI categories. However, Patients with severe steatosis grade (LFC>22.1%) (-10.55%; P=0.001) and HbA1c levels > 7.5% (-8.75%; P= 0.015) achieved significantly higher LFC reductions than other steatosis grades and HbA1c categories. Conclusion: PTX presented a similar efficacy profile in reducing LFC in different fibrosis scores, genders, and BMI categories, while patients with severe steatosis grade and HbA1c > 7.5% achieved higher LFC reductions.
Keywords
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