Characteristics of women with deep vein thrombosis (DVT) or pulmonary embolism (PE) during the MORE trial

Background: Raloxifene (RLX) increases the risk of DVT/PE by ∼ 3-fold in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial. Methods: Postmenopausal (PM) women with osteoporosis were randomized to RLX 60 or 120 mg/d, or placebo (PL; n=7705) and treated for ≤4 years. Women adjudicated with serious adverse events of DVT/PE were assessed for known DVT/PE risks. Results: In all, 64 PM women had a DVT/PE: 44 DVT, 14 PE, 6 both DVT/PE. Sixty-nine percent of events were in women who had ≥1 additional risk: 53% had concurrent immobilization (25% major surgery, 14% hospitalization >3 days without surgery, 8% trauma/fracture limb, 6% longhaul flight) and 27% had hypercoagulable state (9% advanced cancer, 11% history of DVT/PE, 8% genetic variant) [RLX v PL, overall P >0.7]). No deaths caused by DVT/PE were attributed to RLX. Of the 6 RLX-treated women who had a recurrent DVT/PE during the trial, 5 had this event in the first 13 months. During the first 2 years when most events occurred, 9% and 6% of RLX-treated women were on chronic aspirin and statins, respectively versus 0% and 0% for PL. Twenty-nine percent of RLX- and 56% of PL-treated women used estrogen previously. Conclusion: Most PM women with DVT/PE in the MORE trial had ongoing risk factors for DVT/PE, including immobilization and hypercoagulable state. Whether treatment with statins or aspirin reduces occurrence of DVT/PE while on RLX therapy requires further study.