Table 2.
Summary of clinical trials in NAFLD patients employing thiazolidinediones (TZDs).
| References | Study design | Patients number and features | Therapy and duration follow-up | Study outcomes |
|---|---|---|---|---|
| Wang et al. 2006 [130] | OL | 60 pts (DM2); NAFLD, elevated AMTs | Rosiglitazone 4–8 mg/day; 24 weeks | ↓ AMTs ↓ IR ↓ fasting plasma glucose and insulin ↓ HBA1C |
| Akyuz et al. 2007 [131] | OL | 11 pts NAFLD, elevated ALT | Rosiglitazone 4 mg/day vs. metformin vs. diet; 12 months | ↓ AMTs ↓ IR Histology not improved |
| Idilman et al. 2008 [114] | OL, RAND | 25 pts; NASH, elevated AMTs | Rosiglitazone 8 mg/day vs. metformin vs. diet; 12 months | ↓ AMTs Histology improved ↓ IR ↓ C-reactive protein |
| Belfort et al. 2006 [132] | PLAC, RAND | 26 pts (IGT/DM2); NASH | Pioglitazone 30 mg/day vs. placebo for the first 2 months, then 45 mg/day for 4 more months | ↓ ALT ↓ IR ↓ Liver fat ↓ Liver inflammation ↓ Ballooning necrosis Fibrosis not improved |
| Aithal et al. 2008 [133] | PLAC, RAND | 31 pts; NASH | Pioglitazone 30 mg/day vs. placebo; 12 months | ↓ ALT improved ↓ Liver inflammation Fibrosis improved |
| Ratziu V et al. 2008 [134] | OL, PLAC, RAND | 32 pts; NASH, elevated AMTs | Rosiglitazone 4 mg/day vs. placebo for the first month then 8 mg/day for 11 more months | ↓ AMTS ↓ Liver fat ↓ IR |
| Omer et al. 2010 [135] | OL, RAND | 42 pts; (IGT/DM2); NAFLD, elevated ALT | Rosiglitazone 4 mg/day alone vs. Rosiglitazone + metformin; 12 months | ↓ ALT ↓ IR ↓ Liver fat Fibrosis not improved |
| Ratziu V et al. 2010 [136] | OL extension, RAND | 18 pts; NASH | Rosiglitazone 8 mg/day, 3 years | ↓ ALT ↓ IR Histology not further improved |
| Sanyal AJ et al. 2010 [137] | PLAC, RAND | 80 pts; NASH | Pioglitazone 30 mg/day vs. Vit E vs. placebo; 96 weeks | ↓ ALT ↓ IR ↓ Liver fat ↓ Liver inflammation ↓ Ballooning necrosis Fibrosis not improved |
Abbreviations: ALT, alanine transaminase; AMTs, aminotransferases; AST, aspartate aminotransferase; IGT, impaired fasting glucose; IR, insulin resistance; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; NT2DM, non type 2 diabetes mellitus; OB, obese; OL, open label; OW, overweight; PLAC, placebo controlled; RAND, randomized; SA, single arm; T2DM, type 2 diabetes mellitus.