DENVER(EGMN) –A novel oral formulation of tranexamic acid provided immediate and enduring improvement in two quality of life measures among women with menorrhagia in a large open-label study.

The improved quality of life benefits were noted during the first menstrual cycle after initiating treatment. Also, the benefits were maintained throughout the 15-cycle study, Dr. Ken Muse reported at the annual meeting of the American Society for Reproductive Medicine.

Tranexamic acid is a lysine analogue that acts as a competitive plasmin inhibitor and an antifibrinolytic agent. The oral formulation was approved by the U.S. Food and Drug Administration late last year for the treatment of cyclic heavy menstrual bleeding. It’s a valuable alternative to surgical or hormonal treatments for this disorder, which affects up to 22 million Americans, said Dr. Muse of the University of Kentucky, Lexington.

Oral tranexamic acid won marketing approval on the strength of studies showing it reduced menstrual flow by nearly 40%. The quality of life study was conducted because what drives many women to consult a physician regarding menorrhagia is the disorder’s negative impact on their daily activities.

The study involved 723 women who took oral tranexamic acid at 1.3 g three times per day for a maximum of 5 days per menstrual cycle, starting with the onset of heavy menstrual bleeding. General quality of life was assessed using the 36-Item Short Form Health Survey. The Aberdeen Menorrhagia Clinical Outcome Questionnaire (AMCOQ) was used as a disease-specific measure of the impact of treatment.

Significant improvements were noted in six of eight SF-36 categories and domains at cycle 15, compared with baseline. The greatest improvements were in vitality, with a 13.5% gain, and social functioning, with an 8.3% gain. Patients also showed significant long-term improvements in bodily pain, mental health, role-physical, and role-emotional items. Only physical functioning and general health weren’t significantly different at cycle 15, compared with baseline.

Women on oral tranexamic acid had a mean 5.4% long-term improvement in the mental health component of the SF-36, and a less robust but nonetheless significant 1.7% gain in the physical functioning component, according to Dr. Muse.

Oral tranexamic acid was well tolerated. Adverse events deemed by investigators to be probably or definitely treatment related occurred in 7.3% of subjects; these were mild to moderate in nature and most often consisted of headache, menstrual discomfort, or back pain. There were few gastrointestinal side effects, and no thrombotic or thromboembolic events.

Scores on the AMCOQ indicated patients had a consistent improvement in daily activities that are affected by cyclic heavy menstrual bleeding.

The study was funded by Xanodyne Pharmaceuticals Inc. and Ferring Pharmaceuticals, which acquired global marketing rights to oral tranexamic acid last May. Dr. Muse disclosed that he has received research grants and served as an adviser to Xanodyne.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

丹佛 (EGMN) ——据一项大规模开放性研究显示，对月经过多的女性应用一种新型氨甲环酸口服制剂可使两项生活质量相关指标产生快速而持久的变化。

本研究共纳入723例存在月经过多症状的女性，一旦出现月经期大出血症状便立即开始服用氨甲环酸(每日3次，每次1.3g，每个月经周期最多持续服药5天)。研究者使用包含36个问题的健康调查短表(SF-36问卷)对患者的总体生活质量进行评估，使用阿伯丁月经过多临床转归调查问卷(AMCOQ)评估治疗产生的疾病特异性反应。

该药起效快且药效持久，其在患者服药后第1个月经周期便开始生效，一直持续到第15个月经周期。SF-36问卷(共包含8大类指标)调查结果表明，患者在治疗后第15个月经周期时有6大类指标较基线时显著改善。改善幅度最大的是生命活力指标(增高13.5%)和社会功能指标(增高8.3%)。

患者在身体疼痛、精神健康、躯体角色和情感角色等4大类指标上也取得了显著而长久的改善。仅有躯体功能和总体健康状况2大类指标较基线时无显著差异。AMCOQ评分显示，患者的日常活动能力显著改善。

患者对氨甲环酸口服药的耐受性较好，受试者出现疑似或确定的治疗相关不良事件的几率为7.3%，且多数情况下仅限于头痛、经期不适或背痛等轻、中度不良事件。仅有极少数患者出现胃肠道不良事件，所有患者均未发生血栓形成或血栓栓塞事件。

在美国，约有2,200万美国人存在月经期经血过多，而氨甲环酸口服制剂有望作为手术或激素治疗的有效替代方案。

本研究由氨甲环酸口服药的全球经销商Xanodyne制药公司和辉凌制药公司资助。研究者披露曾接受Xanodyne公司的研究经费并担任该公司顾问。

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