A non-interventional study with dienogest 2 mg to assess
Transcription
A non-interventional study with dienogest 2 mg to assess
A non-interventional study with dienogest 2 mg to assess the quality of life in patients with endometriosis (DIVA study) Abstract ID : 1576 Soumis par : Le 2016-03-09 09:47:36 Nom de la catégorie : SEUD CONGRESS Typologie : Poster Statut : validé Autorisation de diffusion : Yes/Oui ------------------------------------Introduction: Endometriosis is a common, chronic, progressive and recurrent disease affecting the quality of life (QoL) of patients. The safety and efficacy of dienogest (DNG) 2 mg daily in endometriosis have been demonstrated in several clinical studies in adults and adolescents. This prospective, non-interventional, multicenter study investigated the QoL, safety and efficacy of DNG in an adult population under real-life conditions (n=2866, efficacy analysis set) at 213 investigational sites in 11 countries in Europe and the Middle East. Material and methods: Primary variable was the percentage of patients who showed an improvement of the Endometriosis Health Profile 5 (EHP-5) items after 6 months of treatment. Secondary variables included reduction of patient-reported endometriosis-associated pain severity derived from an 11-point Numeric Rating Scale (NRS; 0 to 10=unbearable pain) at baseline and after 6 months of treatment, and incidence rates of adverse events. Results: For all domains of the QoL questionnaire EHP-5, most patients showed moderate or strong improvement (i.e. improvement in item rating of 1 or >1, respectively) after 6 months of treatment. Strongest improvement was within the domains “pain controls life” (49.7% with strong improvement), “mood changes” (45.7% with strong improvement) and “feel worried about having intercourse because of pain” (49.6% with strong improvement). At baseline, mean endometriosis-associated pain was 6.0+/-2.1 on the NRS. After 6 months of treatment, mean change from baseline was -4.7+/-2.3 and after 12 months it was -5.0+/-2.1. The most frequently reported adverse events were menstrual disturbances (2.8% patients), depression (0.6%), and weight increase (0.6%). 880 patients continued study drug intake beyond 6 months. Of those who terminated the study after 6 months, 60.9% (n=1205) discontinued due to treatment success, and 33.4% (n=661) due to the patients’ wish to conceive. Conclusion: These are the first data on DNG 2 mg during real-life use in a heterogeneous population from 11 countries. They confirm the efficacy and safety data gathered in clinical trials and show that DNG 2 mg improves the QoL of patients with endometriosis. Acknowledgement: This study was funded by Bayer Pharma. ------------------------------------Mots clefs : Dienogest, DIVA Study, Endometriosis, Progestins Auteurs : Références : , , , Auteurs Maria Yarmolinskaya 1, Irina Makarova 2, Renata Veremiova 3, Christiane Von Ludwig 4, Kerstin Gude 4, 1. North-Western Branch, Ott’s Scientific Research Institute of Obstetrics, Gynecology and Reproduction, SaintPetersburg, RUSSIAN FEDERATION 2. Medical Affairs, AO Bayer, Moscow, RUSSIAN FEDERATION 3. Pharmaceuticals Division, Bayer Ltd, Kyiv, UKRAINE 4. Global Medical Affairs, Bayer Pharma AG, Berlin, GERMANY Auteurs (raw format) Yarmolinskaya Maria - email : [email protected] Etablissement : Ott’s Scientific Research Institute of Obstetrics, Gynecology and Reproduction Service : North-Western Branch Ville : Saint-Petersburg Pays : RUSSIAN FEDERATION Présentateur : Oui Makarova Irina - email : [email protected] Etablissement : AO Bayer Service : Medical Affairs Ville : Moscow Pays : RUSSIAN FEDERATION Présentateur : Non Veremiova Renata - email : [email protected] Etablissement : Bayer Ltd Service : Pharmaceuticals Division Ville : Kyiv Pays : UKRAINE Présentateur : Non Von Ludwig Christiane - email : [email protected] Etablissement : Bayer Pharma AG Service : Global Medical Affairs Ville : Berlin Pays : GERMANY Présentateur : Non Gude Kerstin - email : [email protected] Etablissement : Bayer Pharma AG Service : Global Medical Affairs Ville : Berlin Pays : GERMANY Présentateur : Non