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Comparison of the pharmacologic and clinical profiles of new combined oral contraceptives containing estradiol

机译:含雌二醇的新型联合口服避孕药的药理和临床概况比较

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Abstract: Three estradiol (E2)-containing oral contraceptives, estradiol valerate/cyproterone acetate (E2V/CPA, Femilar?), estradiol valerate/dienogest (E2V/DNG, Qlaira?/Natazia?), and estradiolomegestrol acetate (E2/NOMAC; Zoely?), have received approval for use in general practice. Only Finnish women currently have access to all three E2-based formulations. E2/NOMAC is currently approved only in Europe, while E2V/DNG is approved globally. To assist clinicians counseling women considering use of one of these formulations, we conducted a review of the published information about the current E2-containing oral contraceptives. A literature search was conducted using the Ovid interface and a combination of free search terms relevant to estradiol and oral contraception to identify suitable articles for inclusion in this review. The available data show that E2V/DNG, E2/NOMAC, and E2V/CPA are all effective oral contraceptives. While direct comparisons are lacking, indirect evidence suggests that E2V/DNG and E2/NOMAC may have better bleeding profiles than E2V/CPA. E2V/DNG is also approved for the treatment of heavy menstrual bleeding. Both E2V/DNG and E2/NOMAC have minimal influence on hemostatic, lipid, and carbohydrate metabolism parameters, or induce less change in these parameters relative to ethinylestradiol-based oral contraceptives. However, the predictive value of these surrogate parameters is a matter of debate, and whether these differences can be translated into meaningful clinical outcomes needs to be established in large-scale, post-marketing, prospective, Phase IV cohort studies. Future studies are required to determine whether E2-based oral contraceptives confer additional benefits compared with those of ethinylestradiol-based COCs.
机译:摘要:三种含雌二醇(E2)的口服避孕药,戊酸雌二醇/醋酸环丙孕酮(E2V / CPA,Femilar?),戊酸雌二醇/地诺孕(E2V / DNG,Qlaira®/ Natazia?)和雌二醇/醋酸萘甲酚(E2 / NOMAC; Zoely?)已获准用于一般实践。目前只有芬兰女性可以使用所有三种基于E2的配方。 E2 / NOMAC目前仅在欧洲获得批准,而E2V / DNG在全球获得批准。为了帮助临床医生为考虑使用这些配方之一的女性提供咨询,我们对有关当前含E2口服避孕药的已发布信息进行了回顾。使用Ovid界面以及与雌二醇和口服避孕药相关的免费搜索词的组合进行文献搜索,以找出适合本次评论的文章。现有数据表明,E2V / DNG,E2 / NOMAC和E2V / CPA都是有效的口服避孕药。尽管缺乏直接比较,但间接证据表明E2V / DNG和E2 / NOMAC的出血情况可能比E2V / CPA好。 E2V / DNG也被批准用于治疗严重的月经出血。与基于乙炔雌二醇的口服避孕药相比,E2V / DNG和E2 / NOMAC对止血,脂质和碳水化合物代谢参数的影响极小,或者这些参数的变化较小。但是,这些替代参数的预测价值尚有争议,是否需要在大规模,上市后,前瞻性IV期队列研究中确定这些差异是否可以转化为有意义的临床结果。与基于乙炔雌二醇的COC相比,基于E2的口服避孕药是否还具有其他益处,需要进行进一步的研究。

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