A Maiorana1, Domenico Incandela2, F Parazzini3,4, W Alio1, A Mercurio1, L Giambanco1, L Alio1. 1. Department of Obstetrics and Gynecology, A.R.N.A.S. Civico Hospital, Piazza Nicola Leotta 4, 90127, Palermo, Italy. 2. Department of Obstetrics and Gynecology, A.R.N.A.S. Civico Hospital, Piazza Nicola Leotta 4, 90127, Palermo, Italy. domenicoincandela@hotmail.it. 3. Dipartimento Materno Infantile Clinica Ostetrico Ginecologica, Università di Milano, Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico, Via Commenda 12, 20122, Milan, Italy. 4. Dipartimento di Scienze Cliniche e di Comunità, Universita' di Milano, Via Commenda 9/12, 20122, Milan, Italy.
Abstract
PURPOSE: Dienogest has recently been marketed as a medical treatment for endometriosis. Given the recent introduction on the market of Dienogest, little data are available regarding its effectiveness in routine clinical practice. METHODS: The study is an observational, single-center, cohort study. Eligible was women with a surgical diagnosis of endometriosis dating back <24 months or a clinical/instrumental diagnosis of endometriosis and endometriosis-associated pelvic pain score of at least 40 mm on a 100-mm visual analog scale (VAS) at start of treatment and who had been taking Dienogest 2 mg once daily treatment at the time of study entry for no more than 30 days, consecutively observed between September 2013 to September 2014. In accordance with routine practice, women came back for clinical assessment and evaluation of pain after 1 (V1), 3 (V2), and 12 (V3) months. RESULTS: A total of 132 women were enrolled in the study. A total of 21 of the enrolled patients were released from the study during follow-up due to adverse effects. The mean pelvic pain VAS score at baseline was 8.9 (SD 1.3). The corresponding values were 6.7 (SD 3.2) and 5.7 (SD 3.7) for dyspareunia and dyschezia. The mean VAS scores progressively and significantly decreased to 0.9 (SD 1.6) for pelvic pain, 1.4 (SD 2.1) for dyspareunia and 0.2 (SD 0.9) for dyschezia, respectively, 12 months after start of treatment. CONCLUSION: This study confirms that in routine clinical practice, Dienogest 2 mg is an effective and well-tolerated treatment for endometriosis-related pain in women with endometriosis.
PURPOSE: Dienogest has recently been marketed as a medical treatment for endometriosis. Given the recent introduction on the market of Dienogest, little data are available regarding its effectiveness in routine clinical practice. METHODS: The study is an observational, single-center, cohort study. Eligible was women with a surgical diagnosis of endometriosis dating back <24 months or a clinical/instrumental diagnosis of endometriosis and endometriosis-associated pelvic pain score of at least 40 mm on a 100-mm visual analog scale (VAS) at start of treatment and who had been taking Dienogest 2 mg once daily treatment at the time of study entry for no more than 30 days, consecutively observed between September 2013 to September 2014. In accordance with routine practice, women came back for clinical assessment and evaluation of pain after 1 (V1), 3 (V2), and 12 (V3) months. RESULTS: A total of 132 women were enrolled in the study. A total of 21 of the enrolled patients were released from the study during follow-up due to adverse effects. The mean pelvic pain VAS score at baseline was 8.9 (SD 1.3). The corresponding values were 6.7 (SD 3.2) and 5.7 (SD 3.7) for dyspareunia and dyschezia. The mean VAS scores progressively and significantly decreased to 0.9 (SD 1.6) for pelvic pain, 1.4 (SD 2.1) for dyspareunia and 0.2 (SD 0.9) for dyschezia, respectively, 12 months after start of treatment. CONCLUSION: This study confirms that in routine clinical practice, Dienogest 2 mg is an effective and well-tolerated treatment for endometriosis-related pain in women with endometriosis.
Authors: Kerstin Becker; Klaas Heinemann; Bruno Imthurn; Lena Marions; Sabine Moehner; Christoph Gerlinger; Marco Serrani; Thomas Faustmann Journal: Sci Rep Date: 2021-10-14 Impact factor: 4.379