Does the presence of coexisting diseases modulate the effectiveness of a low-dose estrogen/progestin, ethinylestradiol/drospirenone combination tablet in dysmenorrhea? Reanalysis of two randomized studies in Japanese women

Mikio Momoeda,1 Masakane Hayakawa,2 Yukio Shimazaki,3 Hideki Mizunuma,4 Yuji Taketani5 1Department of Integrated Women's Health, St Luke's International Hospital, Tokyo, 2Medical Affairs, 3Product Development, Bayer Yakuhin, Ltd, Osaka, 4Department of Obstetrics and Gynecology, Faculty of Medicine, Hirosaki University, Hirosaki, 5Japan Labour Health and Welfare Organization, Kawasaki, JapanBackground: The purpose of this study was to investigate the effectiveness of a combination of ethinylestradiol (EE) and 0.02 mg/drospirenone (DRSP) 3 mg in Japanese women with dysmenorrhea and in particular to determine whether or not the presence of specific coexisting organic diseases (eg, endometriosis, uterine fibroids, uterine adenomyosis) has an impact on treatment.Methods and results: Four hundred and ten patients with dysmenorrhea aged 20 years or older (315 without coexisting organic disease, 28 with endometriosis, 37 with uterine fibroids, and 46 with uterine adenomyosis [some patients had multiple coexisting organic diseases]) were enrolled and treated with EE/DRSP in either a 16-week comparator study or a 52-week long-term safety study. Evaluations included changes in total dysmenorrhea score, visual analog scale for dysmenorrhea, severity of symptoms, hormone levels, endometrial thickness, and safety outcomes. In both studies, the total dysmenorrhea score was significantly (P