22 A post hoc analysis of a cohort of 1280 women from the pooled RE-COVER I, RE-COVER II, and RE-MEDY trials reported a significantly lower rate of AUB in women treated with LMWH and dabigatran compared with those treated with LMWH and warfarin (5.9% vs 9.6% OR, 0.59 95% CI, 0.39-0.90). 21 In the Hokusai study, vaginal bleeding occurred in 158 patients (9%) treated with edoxaban compared with 126 patients (7.1%) treated with enoxaparin or warfarin.
Although the absolute number of vaginal bleeding events was comparable between recipients of apixaban and enoxaparin or warfarin, the relative occurrence of vaginal bleeds among all clinically relevant non-major bleeds was higher in women treated with apixaban (OR, 3.4 95% CI, 1.8-6.7). 17 In a cohort from the AMPLIFY study, clinically relevant non-major vaginal bleeding occurred in 28 (2.5%) of 1122 women treated with apixaban and in 24 (2.1%) of 1106 women treated with warfarin (odds ratio, 1.2 95% CI, 0.67-2.0). 5 Definition and brief discussion of the etiology of HMBĪ cohort study reported that HMB occurred in 9.3% of women treated with apixaban. HMB is likely to be associated with a need for direct treatment of its consequences and compromise of anticoagulant compliance, paradoxically increasing the risk of recurrent thromboembolism. There are limited data on HMB in women who are receiving anticoagulants and, to the best of our knowledge, there are no published or proposed practice guidelines for the management of anticoagulant-associated HMB, 4 despite the major impact HMB has on quality of life, especially in women who require long-term anticoagulation. 2, 3 Because HMB is not usually life-threatening, is chronic in nature, and is not usually a separate prespecified end point in clinical trials of anticoagulant therapy, it is underrecognized by physicians. 1 Despite this, there is an increasing focus on the role that DOACs may play in causing abnormal uterine bleeding (AUB) including HMB.
Physicians and patients share concerns about bleeding complications associated with anticoagulants overall, patients treated with direct oral anticoagulants (DOACs) have a lower rate of life-threating bleeding when compared with patients treated with low-molecular-weight heparin/vitamin K antagonists (LMWH/VKAs). Women who do not respond to medical treatment or who do not wish to retain their fertility should be considered for surgical management. Selection of type of hormonal therapy is based on patient preference, other indications for and contraindications to therapy, adverse effect profile, and ongoing thrombotic risk factors. The risk of thrombosis during anticoagulant therapy with these treatments is not well studied but is likely to be low. For women who require long-term anticoagulation, a levonorgestrel intrauterine system, tranexamic acid (during menstrual flow), high-dose progestin-only therapy, or combined hormonal contraceptives are effective for controlling HMB. In the acute setting, the decision to withhold anticoagulants is based on an individual patient’s risk of thrombosis and the severity of the bleeding. Consequences of HMB should be assessed and treated on an ongoing basis. Premenopausal women should be advised of the potential effect of anticoagulant therapy on menstrual bleeding at the time of treatment initiation. Anticoagulant-associated heavy menstrual bleeding (HMB) is an underrecognized but not uncommon problem in clinical practice.
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