NOMAC-E2 compares to LNG combined oral contraceptives in women over forty: real-world PRO-E2 study
Por:
von Stockum S., Becker K., Bauerfeind A., Franke C., Fruzzetti F., Calaf J., Keck C., Heinemann K.
Publicada:
14 dic 2023
Ahead of Print:
1 ene 2023
Resumen:
Objective To investigate safety and effectiveness of NOMAC-E2 and levonorgestrel-containing COCs (COCLNG) in users over 40.Methods In this large, observational study, new users(1) of NOMAC-E2 and COCLNG were recruited in Europe, Australia, and Latin America and followed-up via questionnaires. Incidence of venous thromboembolism (VTE) was expressed as incidence rate (IR; events/10(4) women-years [WY]). Unintended pregnancy was expressed by the Pearl Index (PI; contraceptive failures/100 WY). Mood and weight changes were defined as mean changes in mood score and percentage of body weight.Results Overall, 7,762 NOMAC-E2 and 6,059 COCLNG users over 40 were followed-up. NOMAC-E2 showed no increased VTE risk compared to COCLNG; confirmed events: 5 NOMAC-E2 (IR 5.9; 95% CI, 1.9-13.7) vs 4 COCLNG (IR 5.9; 95% CI, 1.6-15.1). Unintended pregnancy did not differ substantially between cohorts; confirmed events: 4 NOMAC-E2 (PI 0.05; 95% CI, 0.01-0.13) vs 5 COCLNG (PI 0.08; 95% CI, 0.03-0.18). No differential effect on mood and weight was observed between cohorts.Conclusions NOMAC-E2 can be considered a valid alternative to COCLNG in perimenopausal women.
Filiaciones:
von Stockum S.:
Berlin Ctr Epidemiol & Hlth Res ZEG, Berlin, Germany
Becker K.:
Berlin Ctr Epidemiol & Hlth Res ZEG, Berlin, Germany
Bauerfeind A.:
Berlin Ctr Epidemiol & Hlth Res ZEG, Berlin, Germany
Franke C.:
Berlin Ctr Epidemiol & Hlth Res ZEG, Berlin, Germany
Fruzzetti F.:
Pisa Univ Hosp, Dept Obstet & Gynecol, Pisa, Italy
Calaf J.:
Autonomous Univ Barcelona, Hosp Santa Creu & St Pau, Dept Obstet & Gynaecol, Barcelona, Spain
Keck C.:
Amedes MDL, Hamburg, Germany
Heinemann K.:
Berlin Ctr Epidemiol & Hlth Res ZEG, Berlin, Germany
hybrid, All Open Access; Hybrid Gold
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