Evista Clinical Pharmacology

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Evista - Clinical Pharmacology [Raloxifene]

Treatment of Osteoporosis

The effects of EVISTA on fracture incidence and BMD in postmenopausal women with osteoporosis were examined at 3 years in a large randomized, placebo-controlled, double-blind multinational osteoporosis treatment trial. All vertebral fractures were diagnosed radiographically; some of these fractures also were associated with symptoms (i. e., clinical fractures). The study population consisted of 7705 postmenopausal women with osteoporosis as defined by: a) low BMD (vertebral or hip BMD at least 2.5 standard deviations below the mean value for healthy young women) without baseline vertebral fractures, or b) one or more baseline vertebral fractures. Women enrolled in this study had a median age of 67 years (range 31 to 80) and a median time since menopause of 19 years.

EVISTA, 60 mg administered once daily, increased spine and hip BMD by 2 to 3%. EVISTA decreased the incidence of the first vertebral fracture from 4.3% for placebo to 1.9% for EVISTA (relative risk reduction = 55%) and subsequent vertebral fractures from 20.2% for placebo to 14.1% for EVISTA (relative risk reduction = 30%) (Table 2). All women in the study received calcium (500 mg/ day) and vitamin D (400 to 600 IU/ day). EVISTA reduced the incidence of vertebral fractures whether or not patients had a vertebral fracture upon study entry. The decrease in incidence of vertebral fracture was greater than could be accounted for by increase in BMD alone.

Table 2. Effect of EVISTA on Risk of Vertebral Fractures Number of Patients Absolute Risk
Reduction Relative Risk Reduction (95% CI)
EVISTA Placebo Fractures diagnosed radiographically Patients with no baseline
fracture a n= 1401 n= 1457 Number (%) of patients with
1 new vertebral fracture 27 (1.9%) 62 (4.3%) 2.4% 55%
(29%, 71%) Patients with 1 baseline fracture a n= 858 n= 835 Number (%) of patients with
1 new vertebral fracture 121 (14.1%) 169 (20.2%) 6.1% 30%
(14%, 44%) Symptomatic vertebral fractures All randomized patients n= 2557 n= 2576
Number (%) of patients with 1 new clinical (painful)
vertebral fracture 47 (1.8%) 81 (3.1%) 1.3% 41% (17%, 59%) a
Includes all patients with baseline and at least one follow-up radiograph.