Perricos Alexandra, Wenzl René
a Department of Obstetrics and Gynecology , Medical University of Vienna , Vienna , Austria.
Expert Opin Pharmacother. 2017 Sep;18(13):1391-1397. doi: 10.1080/14656566.2017.1359258. Epub 2017 Jul 28.
Much research has gone into developing medications that can be used to alleviate endometriosis-associated symptoms. In addition to already established medications, a new GnRH antagonist, elagolix, is in development. The novelty of this drug compared to other GnRH antagonists, is its nonpeptide structure, allowing it to be administered orally. Areas covered: We analyzed several Phase I, II and III clinical trials that have evaluated the safety and efficacy of this new medication. Expert opinion: Since many medications have been put on the market and have gained popularity for the treatment of endometriosis-associated symptoms, the demonstration of equality or superiority of effect, tolerability, as well as patient compliance should be assessed when introducing a new drug. While elagolix may have an advantage over established GnRH agonists, in that it does not lead to a 'flare-up' effect, it too, takes a toll on bone mineral density. Nevertheless, studies have shown that this new oral GnRH antagonist is well tolerated, and the side effects have been described as 'mild or moderate'. However, in order to examine whether elagolix can compete with or even surpass established gold-standard medical treatments in this field, further studies that directly compare elagolix to said treatments, might be necessary.
在开发可用于缓解子宫内膜异位症相关症状的药物方面已进行了大量研究。除了已有的药物外,一种新型促性腺激素释放激素(GnRH)拮抗剂艾拉戈利正在研发中。与其他GnRH拮抗剂相比,这种药物的新颖之处在于其非肽结构,使其能够口服给药。涵盖领域:我们分析了多项评估这种新药安全性和有效性的I期、II期和III期临床试验。专家观点:由于已有多种药物上市并在治疗子宫内膜异位症相关症状方面受到欢迎,在引入新药时应评估其疗效、耐受性以及患者依从性的等同性或优越性。虽然艾拉戈利可能比已有的GnRH激动剂具有优势,即它不会导致“flare-up”效应,但它也会对骨矿物质密度产生影响。尽管如此,研究表明这种新型口服GnRH拮抗剂耐受性良好,副作用被描述为“轻度或中度”。然而,为了检验艾拉戈利是否能在该领域与已有的金标准药物治疗竞争甚至超越它们,可能需要进行将艾拉戈利与上述治疗直接比较的进一步研究。