Cut Her Risk for First Vertebral Fracture
EVISTA significantly reduced the risk for first vertebral fracture in 3 years in postmenopausal women with osteoporosis*:

• *The MORE clinical trial included 7,705 postmenopausal women (mean age 67 years).³ All women were osteoporotic³ (mean T-scores at initiation of the trial were -2.6 at the spine, -3.2 at the femoral neck⁴). All were given calcium (500 mg/day) and vitamin D (400-600 IU/day).³

Cut Her Risk for Invasive Breast Cancer
In the MORE trial, EVISTA significantly reduced the risk for invasive breast cancer over 4 years in postmenopausal women with osteoporosis^†:

^†Reduction in risk for invasive breast cancer was a secondary endpoint in the MORE clinical trial.

In the CORE trial, EVISTA (60 mg) significantly reduced the risk for invasive breast cancer in a subset of postmenopausal women from the MORE trial followed for up to 8 years^‡,6,7:

^‡Reduction in risk for invasive breast cancer was a primary endpoint.

• In the 4-year CORE trial, EVISTA reduced the risk for invasive breast cancer by 56% vs placebo, with a 0.9% absolute risk reduction⁸
  • MORE participants who elected to participate in the CORE trial were not re-randomized; women who had been assigned to 120 mg/day in MORE were reassigned to 60 mg/day in CORE⁶

1. Physician's Guide to Prevention and Treatment of Osteoporosis. Washington D.C.: National Osteoporosis Foundation; 2007:11.
2. Data on file, Lilly Research Laboratories (EVI200011002).
3. JAMA. 1999;282:637-645.
4. Data on file, Lilly Research Laboratories (EVI199910005).
5. Data on file, Lilly Research Laboratories (EVI20070730).
6. J Natl Cancer Inst. 2004;96:1751-1761.
7. Data on file, Lilly Research Laboratories (EVI20070813B).
8. Data on file, Lilly Research Laboratories (EVI20070913).

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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.