By Colin Kenny, GP, Dromore
In this study, 101 people with biopsy-proven NASH and prediabetes or type 2 diabetes were recruited. Participants underwent a low-calorie diet and were then randomly assigned to pioglitazone 45 mg/day or placebo for 18 months; this was followed by an 18-month open-label phase with pioglitazone treatment. The primary outcome was a reduction of at least 2 points in the non-alcoholic fatty liver disease activity score, without worsening of fibrosis.
At 18 months, compared with participants receiving placebo, a significantly higher percentage of individuals receiving pioglitazone achieved the primary endpoint (58% versus 17%) and had resolution of NASH (51% versus 19%). Similar findings were noted for improvement in fibrosis. Weight gain was significantly greater in the pioglitazone group (mean, 2.5 kg) compared with the placebo group. The investigators concluded that clinicians should consider pioglitazone for NASH in both people with and without diabetes, especially those with fibrosis. However, its use needs to be balanced with the risks for weight gain, heart failure and bone fractures.
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