Abstract
Objectives Oltipraz, a cancer chemopreventive agent, has an anticirrhotic effect in animals. A phase II trial was designed to investigate the preliminary efficacy of oltipraz therapy in liver fibrosis or cirrhosis. Methods Of 83 patients who were randomized to receive placebo, oltipraz 60 mg bid or oltipraz 90 mg qd for 24 weeks, 68 completed the study without any major protocol violation. Pre- and post-treatment liver biopsies, and blood fibrosis markers were assessed. Key findings Twenty-four weeks of oltipraz treatment showed no significant differences in the proportions of patients showing an improvement in histological outcomes, including Ishak fibrosis score. In the oltipraz 60 mg bid group, there was a trend of decreases in hepatic collagen area and plasma transforming growth factor-β1 (TGF-β1, a blood fibrosis marker) levels from baseline to week 24. In the per-protocol population (n = 68), decreases in plasma TGF-β1 correlated with those in the Ishak fibrosis score, suggesting that circulating TGF-β1 serves a possible indicator for fibrosis treatment. Conclusions No significant differences in liver histological outcomes were seen among the three treatment groups in this 24-week pilot study. Our finding indicates an association between TGF-β1 repression and improvement in the histological index of fibrosis.
| Original language | English |
|---|---|
| Pages (from-to) | 627-635 |
| Number of pages | 9 |
| Journal | Journal of Pharmacy and Pharmacology |
| Volume | 63 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 2011 May 1 |
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Keywords
- clinical trial
- liver fibrosis and cirrhosis
- oltipraz
- TGF-β1
ASJC Scopus subject areas
- Pharmacology
- Pharmaceutical Science
Cite this
Oltipraz therapy in patients with liver fibrosis or cirrhosis : A randomized, double-blind, placebo-controlled phase II trial. / Kim, Sang Geon; Kim, Young Mi; Choi, Jong Young; Han, Joon Yeol; Jang, Jeong Won; Cho, Se Hyun; Um, Soon-Ho; Chon, Chae Yoon; Lee, Dong Hoo; Jang, Ja June; Yu, Eunsil; Lee, Young Sok.
In: Journal of Pharmacy and Pharmacology, Vol. 63, No. 5, 01.05.2011, p. 627-635.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Oltipraz therapy in patients with liver fibrosis or cirrhosis
T2 - A randomized, double-blind, placebo-controlled phase II trial
AU - Kim, Sang Geon
AU - Kim, Young Mi
AU - Choi, Jong Young
AU - Han, Joon Yeol
AU - Jang, Jeong Won
AU - Cho, Se Hyun
AU - Um, Soon-Ho
AU - Chon, Chae Yoon
AU - Lee, Dong Hoo
AU - Jang, Ja June
AU - Yu, Eunsil
AU - Lee, Young Sok
PY - 2011/5/1
Y1 - 2011/5/1
N2 - Objectives Oltipraz, a cancer chemopreventive agent, has an anticirrhotic effect in animals. A phase II trial was designed to investigate the preliminary efficacy of oltipraz therapy in liver fibrosis or cirrhosis. Methods Of 83 patients who were randomized to receive placebo, oltipraz 60 mg bid or oltipraz 90 mg qd for 24 weeks, 68 completed the study without any major protocol violation. Pre- and post-treatment liver biopsies, and blood fibrosis markers were assessed. Key findings Twenty-four weeks of oltipraz treatment showed no significant differences in the proportions of patients showing an improvement in histological outcomes, including Ishak fibrosis score. In the oltipraz 60 mg bid group, there was a trend of decreases in hepatic collagen area and plasma transforming growth factor-β1 (TGF-β1, a blood fibrosis marker) levels from baseline to week 24. In the per-protocol population (n = 68), decreases in plasma TGF-β1 correlated with those in the Ishak fibrosis score, suggesting that circulating TGF-β1 serves a possible indicator for fibrosis treatment. Conclusions No significant differences in liver histological outcomes were seen among the three treatment groups in this 24-week pilot study. Our finding indicates an association between TGF-β1 repression and improvement in the histological index of fibrosis.
AB - Objectives Oltipraz, a cancer chemopreventive agent, has an anticirrhotic effect in animals. A phase II trial was designed to investigate the preliminary efficacy of oltipraz therapy in liver fibrosis or cirrhosis. Methods Of 83 patients who were randomized to receive placebo, oltipraz 60 mg bid or oltipraz 90 mg qd for 24 weeks, 68 completed the study without any major protocol violation. Pre- and post-treatment liver biopsies, and blood fibrosis markers were assessed. Key findings Twenty-four weeks of oltipraz treatment showed no significant differences in the proportions of patients showing an improvement in histological outcomes, including Ishak fibrosis score. In the oltipraz 60 mg bid group, there was a trend of decreases in hepatic collagen area and plasma transforming growth factor-β1 (TGF-β1, a blood fibrosis marker) levels from baseline to week 24. In the per-protocol population (n = 68), decreases in plasma TGF-β1 correlated with those in the Ishak fibrosis score, suggesting that circulating TGF-β1 serves a possible indicator for fibrosis treatment. Conclusions No significant differences in liver histological outcomes were seen among the three treatment groups in this 24-week pilot study. Our finding indicates an association between TGF-β1 repression and improvement in the histological index of fibrosis.
KW - clinical trial
KW - liver fibrosis and cirrhosis
KW - oltipraz
KW - TGF-β1
UR - http://www.scopus.com/inward/record.url?scp=79954780467&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79954780467&partnerID=8YFLogxK
U2 - 10.1111/j.2042-7158.2011.01259.x
DO - 10.1111/j.2042-7158.2011.01259.x
M3 - Article
VL - 63
SP - 627
EP - 635
JO - Journal of Pharmacy and Pharmacology
JF - Journal of Pharmacy and Pharmacology
SN - 0022-3573
IS - 5
ER -