TY - JOUR
T1 - Heavy menstrual bleeding in women on anticoagulant treatment for venous thromboembolism: Comparison of high- and low-dose rivaroxaban with aspirin
AU - Boonyawat, K.
AU - Lensing, A.W.A.
AU - Prins, M.H.
AU - Beyer-Westendorf, J.
AU - Prandoni, P.
AU - Martinelli, I.
AU - Middeldorp, S.
AU - Pap, A.F.
AU - Weitz, J.I.
AU - Crowther, M.
N1 - Funding Information:
KB declares no conflict of interest. AWAL and AFP are employees of Bayer AG; MHP reports receiving personal fees from Bayer AG; JB-W received personal fees and fees paid to his institution from Bayer, Daiichi Sankyo, DOASENSE, and Portola; and fees paid to his institution from Pfizer. IM received fees from Sanofi and Bayer. SM received grants and fees paid to her institution from GSK, BMS/Pfizer, Aspen, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Sanofi, and Portola. PP received personal fees from Bayer and Sanofi; JIW received, honoraria from Bayer AG, Pfizer, Bristol-Meyers Squibb, Daiichi Sankyo, Portola, Anthos, Ionis and Tetherex. MAC reports that in the past 24?months he has sat on a Data and Safety Monitoring Board for Bayer; has served on advisory boards for Servier Canada, Asahi Kasei, Precision Biologics, and Hemostasis Reference Laboratory; and has received personal fees from Pfizer, CSL Behring, and Diagnostica Stago.
Publisher Copyright:
© 2021 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).
PY - 2021/2
Y1 - 2021/2
N2 - Background: Rivaroxaban may induce heavy menstrual bleeding. It is unknown if this effect is dose related or if rivaroxaban is associated with more menstrual bleeding than aspirin.Objectives: To demonstrate and compare menstrual patterns and actions taken among women receiving aspirin and two doses of rivaroxaban.Methods: The EINSTEIN-CHOICE trial compared once-daily rivaroxaban 20 mg, rivaroxaban 10 mg, and aspirin 100 mg for extended treatment of venous thromboembolism in patients who had completed 6 to 12 months of anticoagulant therapy. In 362 women with menstrual cycles, menstrual flow duration and intensity assessed at days 30, 90, 180, and 360 were compared with those before starting anticoagulant therapy.Results: Menstrual flow duration increased in 12%-18% of the 134 women given 20-mg rivaroxaban, in 6% to 12% of 120 women given 10-mg rivaroxaban, and in 9% to 12% of 108 women given aspirin. Corresponding increases in flow intensity were 19% to 24%, 14% to 21%, and 13% to 20%. The odds ratios (ORs) for increased menstrual flow duration were 1.36 (95% confidence interval [CI], 0.62-2.96) for rivaroxaban 20 mg versus aspirin, 0.77 (95% CI, 0.33-1.81) for rivaroxaban 10 mg versus aspirin, and 0.57 (95% CI, 0.26-1.25) for rivaroxaban 10 mg versus 20 mg. The ORs for increased menstrual flow intensity were 1.41 (95% CI, 0.67-2.99), 1.07 (95% CI, 0.49-2.34), and 0.76 (95% CI, 0.37- 1.57), respectively.Conclusions: There were no statistically significant differences in menstrual hemorrhage patterns between women treated with 10 or 20 mg of rivaroxaban and aspirin. Compared with 10-mg rivaroxaban or aspirin, 20-mg rivaroxaban showed numerically more often increased menstrual flow duration and intensity.
AB - Background: Rivaroxaban may induce heavy menstrual bleeding. It is unknown if this effect is dose related or if rivaroxaban is associated with more menstrual bleeding than aspirin.Objectives: To demonstrate and compare menstrual patterns and actions taken among women receiving aspirin and two doses of rivaroxaban.Methods: The EINSTEIN-CHOICE trial compared once-daily rivaroxaban 20 mg, rivaroxaban 10 mg, and aspirin 100 mg for extended treatment of venous thromboembolism in patients who had completed 6 to 12 months of anticoagulant therapy. In 362 women with menstrual cycles, menstrual flow duration and intensity assessed at days 30, 90, 180, and 360 were compared with those before starting anticoagulant therapy.Results: Menstrual flow duration increased in 12%-18% of the 134 women given 20-mg rivaroxaban, in 6% to 12% of 120 women given 10-mg rivaroxaban, and in 9% to 12% of 108 women given aspirin. Corresponding increases in flow intensity were 19% to 24%, 14% to 21%, and 13% to 20%. The odds ratios (ORs) for increased menstrual flow duration were 1.36 (95% confidence interval [CI], 0.62-2.96) for rivaroxaban 20 mg versus aspirin, 0.77 (95% CI, 0.33-1.81) for rivaroxaban 10 mg versus aspirin, and 0.57 (95% CI, 0.26-1.25) for rivaroxaban 10 mg versus 20 mg. The ORs for increased menstrual flow intensity were 1.41 (95% CI, 0.67-2.99), 1.07 (95% CI, 0.49-2.34), and 0.76 (95% CI, 0.37- 1.57), respectively.Conclusions: There were no statistically significant differences in menstrual hemorrhage patterns between women treated with 10 or 20 mg of rivaroxaban and aspirin. Compared with 10-mg rivaroxaban or aspirin, 20-mg rivaroxaban showed numerically more often increased menstrual flow duration and intensity.
KW - anticoagulants
KW - aspirin
KW - heavy menstrual bleeding
KW - management
KW - rivaroxaban
KW - therapy
KW - venous thromboembolism
KW - MANAGEMENT
KW - THERAPY
U2 - 10.1002/rth2.12474
DO - 10.1002/rth2.12474
M3 - Article
C2 - 33733030
SN - 2475-0379
VL - 5
SP - 308
EP - 313
JO - Research and practice in thrombosis and haemostasis
JF - Research and practice in thrombosis and haemostasis
IS - 2
ER -