The Efficacy and Safety of Pioglitazone in Patients With Nonalcoholic Steatohepatitis
Summary
Recent studies have demonstrated that PPARγ as well as diet control could improve glycemic control, decrease serum ALT level, decrease hepatic fat distribution, and increase intrahepatic insulin sensitivity. The purposes of this study are: 1\. Primary aims: 1. Comparison between Pioglitazone and placebo groups in terms of steatosis and liver function tests. 2. Evaluation of clinical safety of Pioglitazone 2\. Secondary aims: 1. Comparison between Pioglitazone and placebo groups in terms of liver necroinflammation and fibrosis. 2. The impact of Pioglitazone on the related metabolic index, including insulin resistance(HOMA-IR), newly-onset diabetes, metabolic syndrome, lipid profiles (T-Chol, HDL-C, LDL-C, TG). 3. Comparison between Pioglitazone and placebo groups in terms of high-sensitive C-reactive protein changes. 3\. Interventional aim: Assessment the association between magnetic resonance imaging study and intrahepatic fat distribution before and after Pioglitazone treatment.
Timeline
- Start
- 2009-04
- Primary completion
- 2020-07
- Completion
- 2020-07
Outcome
Met primary endpoint
paper NASH improvement without worsening of fibrosis was achieved in 46.7% (14/30) patients in Arm A, compared to 11.1% (4/36) patients in Arm B (p = 0.002). PMID 34386935 ↗
paper A 24-week pioglitazone treatment was well-tolerated and effective in improving liver histology and reducing liver steatosis in Asian NASH patients. PMID 34386935 ↗
Publications
- Huang JF, Dai CY, Huang CF, Tsai PC, Yeh ML, Hsu PY, Huang SF, Bair MJ, Hou NJ, Huang CI, Liang PC, Lin YH, Wang CW, Hsieh MY, Chen SC, Lin ZY, Yu ML, Chuang WL. First-in-Asian double-blind randomized trial to assess the efficacy and safety of insulin sensitizer in nonalcoholic steatohepatitis patients. Hepatol Int. 2021 Oct;15(5):1136-1147. doi: 10.1007/s12072-021-10242-2. Epub 2021 Aug 12.
- Huang JF, Yeh ML, Huang CF, Huang CI, Tsai PC, Tai CM, Yang HL, Dai CY, Hsieh MH, Chen SC, Yu ML, Chuang WL. Cytokeratin-18 and uric acid predicts disease severity in Taiwanese nonalcoholic steatohepatitis patients. PLoS One. 2017 May 4;12(5):e0174394. doi: 10.1371/journal.pone.0174394. eCollection 2017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pioglitazone | Small molecule | 30 mg | Oral |