欧洲患者报告的子宫内膜异位症药物使用模式:非介入性VIPOS研究的真实结果

IF 0.6 Q4 OBSTETRICS & GYNECOLOGY Journal of endometriosis and pelvic pain disorders Pub Date : 2021-08-03 DOI:10.1177/22840265211035993
K. Becker, K. Heinemann, B. Imthurn, L. Marions, S. Moehner, Sophia von Stockum, C. Gerlinger, M. Serrani, T. Faustmann
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引用次数: 0

摘要

引言:患有子宫内膜异位症的妇女需要个体化的长期治疗。分析处方选择、药物转换、停药和休息可以描述现实世界中的治疗模式,并优化女性的治疗途径。据我们所知,Vi sanne后期批准的观察研究(VIPOS)是最大的现实世界非介入性研究,旨在检查激素治疗对子宫内膜异位症常规临床管理的安全性。我们提供了VIPOS关于子宫内膜异位症药物利用模式的数据,包括因治疗失败而停止治疗。方法:VIPOS是一项前瞻性、长期、对照、非干预性队列研究,于2010年至2018年间在六个欧洲国家(德国、瑞士、俄罗斯、波兰、乌克兰和匈牙利)进行。妇女通过综合问卷自我报告病史和妇科病史、症状以及治疗信息。结果:总共有27840名女性通过妇科医生或专业中心注册。治疗处方模式的国家间差异表明,差异管理策略和指南对处方行为和诊断方法的影响。大多数登记的妇女正在接受激素联合避孕药。女性接受dienogest 2 与其他治疗方法相比,mg或促性腺激素释放激素激动剂更常被手术诊断为子宫内膜异位症,而大多数接受联合激素避孕药、其他孕激素或达那唑的女性都有基于症状的诊断。尽管随访期间的治疗变化很常见,但在42342次治疗开始中,只有4733次因副作用或治疗无效而中断。结论:VIPOS为子宫内膜异位症治疗处方的巨大国家间差异以及不同管理指南和实践策略的潜在作用提供了有价值的见解。本文的研究结果表明,需要更好地协调临床实践,以优化患者管理。
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Patient-reported utilization patterns of endometriosis medications in Europe: Real-world results from the non-interventional VIPOS study
Introduction: Women with endometriosis require individualized, long-term treatment. Analyzing prescription choices, medication switches, discontinuations, and breaks can describe real-world treatment patterns and optimize pathways for women. To our knowledge, the Vi sanne P ost-approval O bservational S tudy (VIPOS) is the largest real-world, non-interventional study examining the safety of hormonal treatments for the routine clinical management of endometriosis. We present data from VIPOS on endometriosis drug utilization patterns, including treatment discontinuation due to treatment failure. Methods: VIPOS was a prospective, long-term, controlled, non-interventional cohort study in six European countries (Germany, Switzerland, Russia, Poland, Ukraine, and Hungary) conducted between 2010 and 2018. Women self-reported medical and gynecological history and symptoms and treatment information via comprehensive questionnaires. Results: Overall, 27,840 women were enrolled via gynecologists or specialized centers. Inter-country variance in treatment prescription patterns suggests the influence of differential management strategies and guidelines on prescribing behavior and diagnostic methods. Most enrolled women were receiving combined hormonal contraceptives. Women receiving dienogest 2 mg or gonadotropin-releasing hormone agonists more often had a surgical diagnosis of endometriosis compared to other treatments, while most women receiving combined hormonal contraceptives, other progestins or danazol had a symptom-based diagnosis. Although treatment changes during follow-up were common, only 4733 discontinuations out of 42,342 treatment starts were reported due to side effects or treatment ineffectiveness. Conclusion: VIPOS provides valuable insights into the considerable inter-country variance in endometriosis treatment prescription and potential role of differing management guidelines and practices strategies. Findings presented here suggest the need greater alignment of clinical practice to optimize patient management.
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