Clinical Studies

Click on a published study from the list below to view the abstract.

• Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women's Health Initiative Randomized Trial
  Cauley JA, Robbins J, Chen Z, et al. JAMA. 2003;290:1729-1738.
  
  
• Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene. Results from a 3-year randomized clinical trial
  Ettinger B, Black DM, Mitlak BH, et al. JAMA. 1999;282:637-645.
  
  
• Effect of raloxifene on the risk of new vertebral fracture in postmenopausal women with osteopenia or osteoporosis: a reanalysis of the Multiple Outcomes of Raloxifene Evaluation trial
  Kanis JA, Johnell O, Black DM, et al. Bone. 2003;33:293-300.
  
  
• Safety assessment of raloxifene over 8 years in a clinical trial setting
  Martino S, Disch D, Dowsett SA, et al. Curr Med Res Opin. 2005;21:1441-1452.
  
  
• Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP study of tamoxifen and raloxifene (STAR) P-2 trial
  Vogel VG, Constantino JP, Wickerham DL, et al. JAMA. 2006;295:2727-2741.
  
  
• Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-year results from the MORE trial
  Cauley JA, Norton L, Lippman ME, et al. Breast Cancer Res Treat. 2001;65:125-134.
  
  
• The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial
  Cummings SR, Eckert S, Krueger KA, et al. JAMA. 1999;281:2189-2197.
  
  

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Important Safety Information for EVISTA

Contraindications
EVISTA is contraindicated in nursing women and in women who are or may become pregnant, as it may cause fetal harm. EVISTA is also contraindicated in women with active or past venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Warnings and Precautions
In a study of postmenopausal women at high risk for cardiovascular disease taking EVISTA, there was no increase in the incidence of stroke; however, there was an increase in death due to stroke. EVISTA also did not increase or decrease the incidence of overall mortality, cardiovascular mortality, or heart attack. The risk-benefit balance should be considered in women at risk for stroke, such as those with prior stroke or transient ischemic attack (TIA), atrial fibrillation, hypertension, or cigarette smoking. EVISTA should be used with caution in patients with hepatic impairment or moderate/severe renal impairment since safety and efficacy have not been established in these patients. The safety of concomitant use of EVISTA with systemic estrogens has not been established and its use is not recommended.

Adverse Reactions
The common adverse reactions considered to be drug related:

Adverse reactions occurring in the clinical trials at a frequency ≥2.0% in either group and in more EVISTA-treated women than in placebo-treated women include:

The majority of adverse reactions occurring during the osteoporosis prevention and treatment studies were mild and generally did not require discontinuation of therapy.

Please see Contraindications, Warnings and Precautions, and Adverse Reactions sections of full Prescribing Information for other Important Safety Information.