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Median study drug exposure was 5. Therapy was discontinued due to an adverse reaction in 25% of 5044 EVISTA-treated women and 24% of 5057 placebo-treated women. The incidence per year of all-cause mortality was similar between the raloxifene (2. Adverse reactions reported more frequently in EVISTA-treated women than in placebo-treated women included peripheral edema (14. Tamoxifen-Controlled Trial Of Postmenopausal Women At Increased Risk For Invasive Breast Cancer (STAR) The safety of EVISTA 60 mg/day versus tamoxifen 20 mg/day over 5 years was assessed in 19,747 postmenopausal women (age range 35-83 years) in a randomized, double-blind trial. As of 31 December 2005, the median follow-up was 4. The safety profile of raloxifene was similar to that in the placebo-controlled raloxifene trials [see Clinical Studies ]. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported very rarely since market introduction include retinal vein occlusion, stroke, and death associated with venous thromboembolism (VTE). Concomitant administration of cholestyramine with EVISTA is not recommended. Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect. EVISTA should not be co-administered with other anion exchange resins [see CLINICAL PHARMACOLOGY ]. If EVISTA is given concomitantly with warfarin or other warfarin derivatives, prothrombin time should be monitored more closely when starting or stopping therapy with EVISTA [see CLINICAL PHARMACOLOGY ]. Other Highly Protein-Bound Drugs. 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