Evista

[Raloxifene]

Comparison of EVISTA and Hormone Replacement Therapy Adverse Events EVISTA was compared with estrogen-progestin replacement therapy (HRT) in three clinical trials for prevention of osteoporosis. Table 7 shows adverse events occurring more frequently in one treatment group and at an incidence 2.0% in any group. Adverse events are shown without attribution of causality.

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Laboratory Changes

The following changes in analyte concentrations are commonly observed during EVISTA therapy: increased apolipoprotein A1; and reduced serum total cholesterol, LDL cholesterol, fibrinogen, apolipoprotein B, and lipoprotein (a). EVISTA modestly increases hormone-binding globulin concentrations, including sex steroid-binding globulin, thyroxine-binding globulin, and corticosteroid-binding globulin with corresponding increases in measured total hormone concentrations. There is no evidence that these changes in hormone-binding globulin concentrations affect concentrations of the corresponding free hormones.

There were small decreases in serum total calcium, inorganic phosphate, total protein, and albumin which were generally of lesser magnitude than decreases observed during ERT/ HRT.

Platelet count was also decreased slightly and was not different from ERT. Additional Safety Information Incidences of estrogen-dependent carcinoma of the endometrium and breast are being evaluated across all completed and ongoing clinical trials involving 17,151 patients, of which at least 10,850 women have received at least one dose of raloxifene. These trials provided over 21,000 person-years of raloxifene exposure with a maximum exposure of 58 months.

Endometrium —

Compared to placebo, raloxifene did not increase the risk of endometrial cancer.

Breast —

Compared to placebo, raloxifene did not increase the risk of breast cancer (see CLINICAL PHARMACOLOGY, Effects on the Breast). Postintroduction Reports Adverse events reported since market introduction include: very rarely -retinal vein occlusion.

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