Safety of Dienogest and Other Hormonal Treatments for Endometriosis in Real-World Clinical Practice (VIPOS): A Large Non
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Safety of Dienogest and Other Hormonal Treatments for Endometriosis in Real-World Clinical Practice (VIPOS): A Large Noninterventional Study Klaas Heinemann . Bruno Imthurn . Lena Marions . Christoph Gerlinger . Kerstin Becker . Sabine Moehner . Thomas Faustmann
Received: October 23, 2019 The Author(s) 2020
ABSTRACT Introduction: Endometriosis is a common gynecologic disease associated with a significant burden on women’s health and healthcare systems. Currently approved hormonal treatments Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12046359.
Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s12325020-01331-z) contains supplementary material, which is available to authorized users. K. Heinemann (&) K. Becker S. Moehner ZEG Berlin, 10115 Berlin, Germany e-mail: [email protected] B. Imthurn Department of Reproductive Endocrinology, University Hospital Zurich, 8091 Zurich, Switzerland L. Marions Department of Clinical Science and Education, Karolinska Institutet, 118 83 Stockholm, Sweden C. Gerlinger Statistics and Data Insights, Bayer AG, 13553 Berlin, Germany C. Gerlinger Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, 66421 Homburg, Saar, Germany T. Faustmann Bayer AG, 13353 Berlin, Germany
for endometriosis can be effective in controlling symptoms, but may have clinically relevant side effects that limit their long-term use. Dienogest 2 mg (Visanne; Bayer AG, Berlin, Germany) is a 19-nortestosterone derivative that significantly reduces menstrual bleeding, dysmenorrhea, premenstrual pain, dyspareunia, and pelvic pain in women with endometriosis. Although dienogest 2 mg has demonstrated efficacy in clinical trials, data regarding long-term and realworld use are limited. Methods: To our knowledge, the Visanne Postapproval Observational Study (VIPOS) is the largest real-world, noninterventional study performed examining the safety of dienogest and other hormonal treatments for the management of endometriosis in routine clinical practice. Patients self-reported medical and gynecologic history and symptoms and treatment information. Primary clinical outcomes were clinically validated and subject to independent blinded adjudication. Loss to follow-up was minimized through active contact with participating women at 6 months postenrollment and annually thereafter to ensure almost all clinically relevant outcomes were captured. Planned Outcomes: VIPOS planned to enroll approximately 25,000 women initiating a new treatment for endometriosis, including those prescribed dienogest 2 mg/day and other hormonal medications for endometriosis (approved or nonapproved), from approximately
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1000 centers in six European countries. The main clinical outcomes of interest for follow-up are anemia requiring medical intervention, de novo or clinically worsening depression, and treatment-failure patterns that result in drug discontinuation. Additional anal
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