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Efficacy of diacerein in reducing liver steatosis and fibrosis in patients with type 2 diabetes and non‐alcoholic fatty liver disease: A randomized, placebo‐controlled trial
Author(s) -
Leite Nathalie C.,
Viegas Bianca B.,
VillelaNogueira Cristiane A.,
Carlos Fernanda O.,
Cardoso Claudia R.L.,
Salles Gil F.
Publication year - 2019
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13643
Subject(s) - steatosis , medicine , fatty liver , gastroenterology , placebo , transient elastography , diabetes mellitus , type 2 diabetes , randomized controlled trial , fibrosis , liver fibrosis , disease , pathology , endocrinology , alternative medicine
The aim was to assess, in a randomized, double‐blinded, placebo‐controlled trial, the efficacy of diacerein, an anti‐inflammatory drug, in improving liver fibrosis and steatosis in patients with type 2 diabetes and non‐alcoholic fatty liver disease (NAFLD). Sixty‐nine diabetic patients with NAFLD were randomized to 24‐month treatment with placebo (35 patients) or diacerein 100 mg/day (34 patients). Liver stiffness and steatosis were assessed by transient elastography (Fibroscan®) at baseline, and 12 and 24 months of follow‐up. The primary outcome was the difference in mean liver stiffness and steatosis changes during treatment. Adjusted differences in mean changes on intention‐to‐treat analyses were estimated by generalized repeated‐measures mixed‐effects regressions. Diacerein significantly reduced liver stiffness in contrast to placebo by 1.6 kPa (95% CI: –2.6 to −0.5 kPa; p = 0.003), whereas no significant difference in mean changes in liver steatosis was observed. The reduction in liver stiffness was already evident at the 12‐month examination, and accentuated at the 24‐month examination. Eight patients reduced liver fibrosis stage during treatment, seven of whom were in the diacerein group (p = 0.020). In conclusion, a 2‐year treatment with diacerein significantly reduced liver fibrosis in diabetic patients with NAFLD.