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Resmetirom proves positive for NASH with liver fibrosis
Nature Reviews Gastroenterology & Hepatology ( IF 65.1 ) Pub Date : 2024-02-15 , DOI: 10.1038/s41575-024-00909-0
Katrina Ray

Positive phase III results have been reported for resmetirom (a thyroid hormone receptor β-selective agonist) for the treatment of nonalcoholic steatohepatitis (NASH; also known as metabolic dysfunction-associated steatohepatitis (MASH)) with liver fibrosis.

In a phase III, randomized controlled trial, 966 patients with biopsy-confirmed NASH and liver fibrosis (stage F1B, F2 or F3) were randomly assigned to receive a once-daily dose of 80 mg resmetirom, 100 mg resmetirom or placebo for 52 weeks. Resolution of NASH with no worsening of fibrosis was achieved in 25.9% of the 80 mg group and 29.9% of the 100 mg group, compared with 9.7% in the placebo group (P < 0.001 for both comparisons). Improvement in fibrosis by at least one stage with no worsening of disease activity scores occurred in 24.2% of the 80 mg group and 25.9% of patients in the 100 mg group, versus 14.2% in the placebo group (P < 0.001 for both comparisons). Moreover, LDL cholesterol levels were also reduced by resmetirom (from baseline to week 24, –13.6% in the 80 mg group, –16.3% in the 100 mg group, 0.1% in the placebo group; P < 0.001).



中文翻译:

Resmetirom 对伴有肝纤维化的 NASH 呈阳性

Resmetirom(一种甲状腺激素受体β选择性激动剂)用于治疗伴有肝纤维化的非酒精性脂肪性肝炎(NASH;也称为代谢功能障碍相关脂肪性肝炎(MASH))已取得积极的 III 期结果。

在一项 III 期随机对照试验中,966 名活检证实患有 NASH 和肝纤维化(F1B、F2 或 F3 期)的患者被随机分配接受每日一次剂量的 80 mg 瑞美罗、100 mg 瑞美罗或安慰剂,为期 52 周。 80 mg 组和 100 mg 组的 NASH 缓解率分别为 25.9% 和 29.9%,而安慰剂组为 9.7%(两项比较P  < 0.001)。 80 mg 组中 24.2% 的患者和 100 mg 组中 25.9% 的患者出现纤维化改善至少一个阶段且疾病活动评分没有恶化的情况,而安慰剂组中这一比例为 14.2%(两项比较 P < 0.001  ) 。此外,瑞美罗还降低了 LDL 胆固醇水平(从基线到第 24 周,80 mg 组降低了 13.6%,100 mg 组降低了 16.3%,安慰剂组降低了 0.1%;P  < 0.001)。

更新日期:2024-02-16
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