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http://ir.nhri.org.tw/handle/3990099045/13650
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| Title: | First-in-Asian double-blind randomized trial to assess the efficacy and safety of insulin sensitizer in nonalcoholic steatohepatitis patients |
| Authors: | 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 |
| Contributors: | Institute of Molecular and Genomic Medicine |
| Abstract: | Background The efficacy and safety of insulin sensitizer in Asians with non-alcoholic steatohepatitis (NASH) remain elusive. Aims The double-blind, randomized, placebo-controlled trial was conducted aiming to investigate the efficacy and safety of pioglitazone in NASH patients. Methods A total of 90 NASH patients (66 males, age = 44.1 +/- 12.7 years) were prospectively randomized into oral pioglitazone 30 mg/day (Arm A) or placebo (Arm B) for 24 weeks. The primary endpoint was the efficacy of pioglitazone in reducing inflammation and liver fat at end-of-treatment (EOT). NASH resolution/improvement without fibrosis worsening was also evaluated. Results At EOT, there was a significantly decline of alanine aminotransferase (86.9 +/- 34.3 to 45.7 +/- 35.8 IU/L, p = 0.003) level in Arm A patients. In intention-to-treat analysis among 66 patients who completed paired biopsies, The NAFLD activity score (NAS) of 30 Arm A patients significantly decreased from 4.27 +/- 1.14 at baseline to 2.53 +/- 1.63 at EOT (p < 0.0001), whereas there was no significant change in patients of Arm B (3.94 +/- 1.41 vs 3.94 +/- 1.51, p = 1.0). 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). Liver fat content reduced (20.2 +/- 9.0 to 14.3 +/- 6.9%, p < 0.0001) on MRI-PDFF in Arm A compared to their counterparts. No significant difference of adverse events occurred between groups. Conclusions A 24-week pioglitazone treatment was well-tolerated and effective in improving liver histology and reducing liver steatosis in Asian NASH patients. (ClinicalTrials.gov number: NCT01068444) |
| Date: | 2021-10 |
| Relation: | Hepatology International. 2021 Oct;15(5):1136-1147. |
| Link to: | http://dx.doi.org/10.1007/s12072-021-10242-2 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1936-0533&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000684496800001 |
| Cited Times(Scopus): | https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85112359549 |
| Appears in Collections: | [黃秀芬] 期刊論文
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| ISI000684496800001.pdf | | 888Kb | Adobe PDF | 138 | View/Open |
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