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