人口统计学和临床因素对艾拉戈利加回输疗法对月经过多和子宫肌瘤女性患者报告的非出血症状的影响：对两项临床试验数据的事后分析

FS Reports Pub Date : 2024-09-01 DOI:10.1016/j.xfre.2024.06.002

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引用次数: 0

摘要

目的研究艾拉戈利加回输疗法（雌二醇[1 毫克]和醋酸炔诺酮[0.5 毫克]，每日一次）对不同亚群患者报告的子宫肌瘤（UFs）相关非出血症状和月经出血的疗效。设计对两项3期临床试验--Elaris UF-1和UF-2进行事后分析。研究地点美国共有76个（UF-1）和77个（UF-2）临床研究机构。干预措施：艾拉戈利（300 毫克）与安慰剂相比，每天两次，每次加回疗法（UF 相关大量月经出血的指定剂量），疗程为 6 个月。主要结果测量指标：非出血症状（腹部/骨盆疼痛、腹部/骨盆压痛/痉挛、背痛和腹胀）和月经出血的 "非常改善 "或 "非常改善"，使用 "患者总体变化印象量表 "进行测量。根据基线特征（年龄、种族[自我报告]、体重指数和国际妇产科联合会子宫肌瘤分类）对亚人群的改善情况进行了评估。在具有与高疾病负担相关的常见特征（年龄40岁，黑人/非裔美国人）的患者中，接受艾拉戈利加回输疗法治疗的患者在第1-6个月的改善程度明显高于接受安慰剂治疗的患者（P<0.05）。临床试验注册号：NCT02654054 和 NCT02691494。

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Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials

Objective

To investigate the efficacy of elagolix plus add-back therapy (estradiol [1 mg] and norethindrone acetate [0.5 mg] once daily) on patient-reported nonbleeding symptoms and menstrual bleeding associated with uterine fibroids (UFs) across different subpopulations.

Design

Post hoc analysis of two phase 3 clinical trials—Elaris UF-1 and UF-2.

Setting

A total of 76 (UF-1) and 77 (UF-2) US clinical sites.

Patient(s)

Women (N = 591) with UFs and heavy menstrual bleeding.

Intervention(s)

Elagolix (300 mg) twice daily with add-back therapy (the indicated dose for UF-associated heavy menstrual bleeding) vs. placebo for 6 months.

Main Outcome Measure(s)

“Very much improved” or “much improved” change in nonbleeding symptoms (abdominal/pelvic pain, abdominal/pelvic pressure/cramping, back pain, and abdominal bloating) and menstrual bleeding measured using a Patient Global Impression of Change scale. Improvements were assessed in subpopulations stratified using baseline characteristics (age, race [self-reported], body mass index, and International Federation of Gynecology and Obstetrics fibroid classification).

Result(s)

Across subpopulations, differences favored elagolix plus add-back therapy (vs. placebo) for most symptoms at month 1 and all symptoms at months 3 as well as 6. In patients with characteristics commonly associated with high disease burden (age >40 years, Black/African American), those treated with elagolix plus add-back therapy reported significantly greater improvements vs. placebo at months 1–6 (P<.05) for all nonbleeding and bleeding symptoms (P≤.05).

Conclusion(s)

Premenopausal women with heavy menstrual bleeding and UFs receiving elagolix plus add-back therapy experienced significant improvements in nonbleeding as well as bleeding symptoms from months 1–6, regardless of baseline characteristics.