Table 1.
Studies of thiazolidinediones in adult patients with biopsy-proven nonalcoholic steatohepatitis.
Study | n | Design | % Diabetes mellitus | Drug* | Daily dose (mg) | Compared with | Duration | Liver enzymes | Liver fat by imaging | Histology |
---|---|---|---|---|---|---|---|---|---|---|
Caldwell et al. [2001] | 10 | Open label, single arm | 10 | Troglitazone | 400 | Baseline | <6 months | Improved | NA | Unchanged |
Neuschwander- Tetri et al. [2003a, 2003b] | 30 | Open label, single arm | 50 | Rosiglitazone | 8 | Baseline | 48 weeks | Improved | Improved (CT) | Improved steatosis, inflammation |
Promrat et al. [2004] | 18 | Open label, single arm | 0 | Pioglitazone | 30 | Baseline | 48 weeks | Improved (normalized in 95%) (NS) | Improved (MRS) | Improved steatosis, inflammation and fibrosis |
Sanyal et al. [2004] | 20 | Open label, RCT | 0 | Pioglitazone + vitamin E | 30 | Vitamin E | 6 months | Improved | NA | Improved steatosis and inflammation. Fibrosis improved (NS) |
Belfort et al. [2006] | 55 | Blinded, RCT | 48 | Pioglitazone | 45 | Placebo | 6 months | Improved | Improved (MRS) | Improved steatosis and inflammation. Fibrosis improved (NS) |
Aithal et al. [2008] | 74 | Blinded, RCT | 0 | Pioglitazone | 30 | Placebo | 12 months | Improved (NS) | NA | Improved hepatocellular injury and fibrosis; steatosis and inflammation improved (NS) |
Idilman et al. [2008] | 74 | Open label, RCT | NR | Rosiglitazone | 8 | Metformin or diet + exercise | 48 weeks | NA | Improved steatosis | |
Ratziu et al. [2008] | 63 | Blinded, RCT | 31 | Rosiglitazone | 8 | Placebo | 12 months | Improved (normalized in 38%) | NA | Improved steatosis, necroinflammation, NAS and fibrosis improved (NS) |
Sanyal et al. [2010] | 74 | Blinded, RCT | 0 | Pioglitazone | 30 | Placebo | 24 months | Improved | NA | Improved steatosis and inflammation (NS) |
All patients in the study arm were also placed on lifestyle modifications with diet and exercise.
CT, computed tomography; MRS, magnetic resonance spectroscopy; NA, not assessed; NAS, Nonalcoholic fatty liver disease Activity Score; NR, not reported; NS, nonsignificant; RCT, randomized controlled trial.