Cut 2 Risks With EVISTA

As postmenopausal women with osteoporosis age, they may be at increased risk for vertebral fracture¹ and invasive breast cancer.² EVISTA is the only agent indicated to treat osteoporosis and reduce the risk for invasive breast cancer in postmenopausal women with osteoporosis.

Learn about other risk factors for osteoporosis and breast cancer.

The Efficacy and Safety of EVISTA Were Studied in Three Large Clinical Trials: MORE, CORE, and RUTH

• In the MORE (Multiple Outcomes of Raloxifene Evaluation) trial:
  • EVISTA significantly reduced the risk for invasive breast cancer over 4 years in postmenopausal women with osteoporosis*^,3
• In the CORE (Continuing Outcomes Relative to EVISTA) trial:
  • EVISTA significantly reduced the risk for invasive breast cancer in a subset of postmenopausal women from the MORE trial followed for up to 8 years^†,4
• In the RUTH (Raloxifene Use for The Heart) trial:
  • The invasive breast cancer risk reduction demonstrated by EVISTA in the MORE and CORE trials was confirmed^†,‡,5

• *Invasive breast cancer risk reduction was a secondary endpoint in the MORE trial.
• †Invasive breast cancer risk reduction was a primary endpoint in the CORE and RUTH trials.
• ‡EVISTA is not recommended for the patient population studied in RUTH. For additional information on this trial, view Clinical Trials.

She's at risk for fracture

• Female
• Age 58
• No history of fracture, T-score -2.5
• No family history of osteoporosis

She may also be at risk for invasive breast cancer

• Female
• Age 58
• No abnormal mammograms
• No family history of breast cancer

Can any other approved osteoporosis agent address both risks?

1. Lancet. 2006;367:2010-2018.
2. American Cancer Society. Breast Cancer Facts & Figures 2005-2006.
   Available at: http://www.cancer.org/downloads/STT/CAFF2005BrF.pdf. Accessed January 12, 2007.
3. Breast Cancer Res Treat. 2001;15:125-134.
4. J Natl Cancer Inst. 2004;96:1751-1761.
5. N Engl J Med. 2006;355:125-137.
6. Manufacturer's prescribing information.

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EVISTA is a registered trademark of Eli Lilly and Company.
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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.