TY - JOUR
T1 - Clinical trial
T2 - Pilot study of metformin for the treatment of non-alcoholic steatohepatitis
AU - Loomba, R.
AU - Lutchman, G.
AU - Kleiner, D. E.
AU - Ricks, M.
AU - Feld, J. J.
AU - Borg, B. B.
AU - Modi, A.
AU - Nagabhyru, P.
AU - Sumner, A. E.
AU - Liang, T. J.
AU - Hoofnagle, J. H.
PY - 2009/1
Y1 - 2009/1
N2 - Background: Non-alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH. Aim: To assess the effects of metformin on insulin sensitivity, body composition, serum alanine aminotransferase (ALT) levels and liver histology in patients with NASH. Methods: Patients underwent liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint was a three-point improvement in the histological NASH activity index. Results: Of 28 patients enrolled, 26 (13 females; average age 44 years) completed 48 weeks of treatment and underwent repeat metabolic studies, imaging and liver biopsy. Thirty per cent achieved a histological response. Most patients lost weight, the average being 6 kg. There was a marked association between weight loss and improvements in NASH activity index and ALT levels (both, P <0.01). Insulin sensitivity also improved, but the degree of change did not correlate with histological improvement. Conclusion: Metformin leads to improvements in liver histology and ALT levels in 30% of patients with NASH, probably by its effects in causing weight loss.
AB - Background: Non-alcoholic steatohepatitis (NASH) is a form of progressive fatty liver disease that is strongly associated with insulin resistance, which suggests that insulin sensitizing agents such as metformin may be beneficial for NASH. Aim: To assess the effects of metformin on insulin sensitivity, body composition, serum alanine aminotransferase (ALT) levels and liver histology in patients with NASH. Methods: Patients underwent liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint was a three-point improvement in the histological NASH activity index. Results: Of 28 patients enrolled, 26 (13 females; average age 44 years) completed 48 weeks of treatment and underwent repeat metabolic studies, imaging and liver biopsy. Thirty per cent achieved a histological response. Most patients lost weight, the average being 6 kg. There was a marked association between weight loss and improvements in NASH activity index and ALT levels (both, P <0.01). Insulin sensitivity also improved, but the degree of change did not correlate with histological improvement. Conclusion: Metformin leads to improvements in liver histology and ALT levels in 30% of patients with NASH, probably by its effects in causing weight loss.
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U2 - 10.1111/j.1365-2036.2008.03869.x
DO - 10.1111/j.1365-2036.2008.03869.x
M3 - Article
C2 - 18945255
AN - SCOPUS:57649229536
SN - 0269-2813
VL - 29
SP - 172
EP - 182
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 2
ER -