First-in-Asian double-blind randomized trial to assess the efficacy and safety of insulin sensitizer in nonalcoholic steatohepatitis patients,Hepatology International

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First-in-Asian double-blind randomized trial to assess the efficacy and safety of insulin sensitizer in nonalcoholic steatohepatitis patients
Hepatology International ( IF 6.6 ) Pub Date : 2021-08-12 , DOI: 10.1007/s12072-021-10242-2
Jee-Fu Huang , Chia-Yen Dai , Chung-Feng Huang , Pei-Chien Tsai , Ming-Lun Yeh , Po-Yau Hsu , Shiu-Feng Huang , Ming-Jong Bair , Nai-Jen Hou , Ching-I Huang , Po-Cheng Liang , Yi-Hung Lin , Chih-Wen Wang , Ming-Yen Hsieh , Shinn-Chern Chen , Zu-Yau Lin , Ming-Lung Yu , Wan-Long Chuang

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)

中文翻译：

亚洲首个评估胰岛素增敏剂对非酒精性脂肪性肝炎患者疗效和安全性的双盲随机试验

背景

胰岛素增敏剂在亚洲非酒精性脂肪性肝炎 (NASH) 患者中的疗效和安全性仍然难以捉摸。

目标

这项双盲、随机、安慰剂对照试验旨在研究吡格列酮在 NASH 患者中的疗效和安全性。

方法

共有 90 名 NASH 患者（66 名男性，年龄 = 44.1 ± 12.7 岁）被前瞻性随机分为口服吡格列酮 30 mg/天（A 组）或安慰剂（B 组），为期 24 周。主要终点是吡格列酮在治疗结束（EOT）时减少炎症和肝脏脂肪的功效。还评估了没有纤维化恶化的 NASH 解决/改善。

结果

在 EOT 时，A 组患者的丙氨酸氨基转移酶（86.9 ± 34.3 至 45.7 ± 35.8 IU/L， p = 0.003）水平显着下降。在完成配对活检的 66 名患者的意向治疗分析中，30 名 A 组患者的 NAFLD 活动评分 (NAS) 从基线时的 4.27 ± 1.14 显着降低至 EOT 时的 2.53 ± 1.63 ( p < 0.0001)，而有B组患者没有显着变化（3.94 ± 1.41 vs 3.94 ± 1.51，p = 1.0）。A 组 46.7% (14/30) 的患者实现了 NASH 改善而不纤维化恶化，而 B 组为 11.1% (4/36) 的患者 ( p = 0.002)。肝脏脂肪含量减少（20.2 ± 9.0 至 14.3 ± 6.9%，p < 0.0001) 在 A 组的 MRI-PDFF 上与其对应物相比。组间不良事件发生率无显着差异。