In a nutshell
The authors aimed to determine the effectiveness and safety of long-term pioglitazone (Actos) treatment in patients with nonalcoholic steatohepatitis (NASH) and prediabetes or type 2 diabetes.
The authors concluded that long-term pioglitazone treatment is safe and effective in patients with NASH and prediabetes or type 2 diabetes.
Some background
NASH is a common liver disease that is similar to alcoholic liver disease but occurs in people who drink little or no alcohol. It results liver inflammation and damage caused by the build-up of fat. NASH is the most common liver disease in prediabetes (condition where blood glucose levels are higher than normal) and type 2 diabetes.
Pioglitazone is a glucose-lowering treatment for type 2 diabetes. Studies suggest that pioglitazone is safe and effetive in patients with NASH and prediabetes or type 2 diabetes but the long-term effects are unknown.
Methods & findings
The aim of this study was to determine the long-term effects of pioglitazone in patients with NASH and prediabetes or type 2 diabetes.
101 patients with NASH and prediabetes or type 2 diabetes were included in this study. Patients were randomly assigned to one of two groups. 50 patients in group 1 received pioglitazone treatment for 36 months. 51 patients in group 2 received a placebo (inactive pill that replaces the active drug) for 18 months. 34 patients from group 1 and 29 patiets from group 2 were then treated with pioglitazone for a further 18 months.
58% of patients in group 1 achieved the primary outcome (improvement of NASH without worsening symptoms at 18 months of treatment). This was compared to 17% in group 2. In patients who had definite NASH at the beginning of the study, 67% in group 1 achieved the primary outcome. This was compared to 17% in group 2.
Resolution of NASH occurred in 51% of patients in group 1. This was compared to 19% in group 2. Patients in group 1 experienced improvements in fat in the liver cells, inflammation and cell injury. Fibrosis (thickening or scarring of tissue) progression occurred in only 12% of group 1 patients. This was compared to 28% of group 2 patients.
Liver fat was reduced from 19% to 7% in group 1. This was compared to from 15% to 11% in group 2. Side-effects to treatment did not differ between the groups. However, weight gain was more frequent in group 1.
Results were similar after 36 months of treatment.
The bottom line
The authors concluded that long-term pioglitazone treatment is safe and effective in patients with NASH and prediabetes or type 2 diabetes.
Published By :
Annals of internal medicine
Date :
Jun 21, 2016
