Long-term treatment of endometriosis with dienogest: Real-world results from the VIPOS study

IF 0.6 Q4 OBSTETRICS & GYNECOLOGY Journal of endometriosis and pelvic pain disorders Pub Date : 2021-02-14 DOI:10.1177/2284026521993688
S. Moehner, K. Becker, J. Lange, Sophia von Stockum, M. Serrani, K. Heinemann
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引用次数: 1

Abstract

Introduction: The Visanne Post-approval Observational Study (VIPOS) was designed to assess the safety of dienogest 2 mg (DNG, Visanne) compared to other hormonal endometriosis treatments. Methods: Large, prospective, non-interventional, active surveillance study in six European countries (Germany, Poland, Russia, Hungary, Switzerland, and Ukraine). Women with a new hormonal therapy for endometriosis were enrolled by gynecologists and specialized centers between 2010 and 2016 and observed for up to 7 years. Self-administered questionnaires during study entry and follow-up collected information on baseline characteristics, health status and endometriosis treatment. Self-reported clinical outcomes of interest were validated by health care professionals. Results: Among the >27,000 enrolled participants, 3262 women started DNG use either at study entry or during follow-up. A total of 798 study participants used DNG during follow-up continuously for 15 months or longer (DNG long-term users). When comparing the occurrence of serious adverse events (SAE) in users treated with DNG, no safety signal emerged for long-term users; the SAE incidence rate per 10,000 women-years was 367.7 (95% CI: 274.1–481.9) in DNG long-term users and 416.4 (349.1–492.5) in short-term users (treated with DNG for less than 15 months). Conclusions: Previous data on DNG long-term safety were derived from studies with relatively low numbers of patients and limited follow-up time. VIPOS provided valuable real-world data on the long-term use of DNG 2 mg in around 800 women treated in Europe and observed no safety signal regarding serious adverse events.
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迪诺吉斯特长期治疗子宫内膜异位症:VIPOS研究的真实结果
Visanne批准后观察性研究(VIPOS)旨在评估dienogest 2mg (DNG, Visanne)与其他激素子宫内膜异位症治疗的安全性。方法:在六个欧洲国家(德国、波兰、俄罗斯、匈牙利、瑞士和乌克兰)进行大规模、前瞻性、非干预性、主动监测研究。2010年至2016年期间,妇科医生和专业中心招募了接受子宫内膜异位症新激素治疗的女性,并对其进行了长达7年的观察。在研究开始和随访期间,自我管理的问卷收集了关于基线特征、健康状况和子宫内膜异位症治疗的信息。自我报告感兴趣的临床结果由卫生保健专业人员验证。结果:在bb27,000名入组参与者中,3262名女性在研究开始或随访期间开始使用DNG。共有798名研究参与者在连续随访15个月或更长时间(DNG长期使用者)期间使用DNG。在比较使用DNG的患者的严重不良事件(SAE)发生情况时,长期使用者未出现安全信号;长期使用DNG的女性年SAE发生率为367.7 (95% CI: 274.1-481.9),短期使用(DNG治疗少于15个月)的女性年SAE发生率为416.4(349.1-492.5)。结论:先前关于DNG长期安全性的数据来自于患者数量相对较少且随访时间有限的研究。VIPOS提供了关于在欧洲接受治疗的约800名妇女长期使用DNG 2mg的有价值的真实数据,并没有观察到关于严重不良事件的安全信号。
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CiteScore
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