Protect Her Bones

Vertebral fractures:

• Are the most common type of osteoporotic fracture¹
• Lead to an elevenfold increase in risk for subsequent vertebral fractures²
• Begin to increase in incidence earlier than hip fractures³

Vertebral Fracture Risk Reduction
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).⁵ All women were osteoporotic⁵ (mean T-scores at initiation of trial were -2.6 at the spine, -3.2 at the femoral neck⁶). All were given calcium (500 mg/day) and vitamin D (400-600 IU/day).⁵

Radius and Spine are Most Common First Fracture Sites in Osteoporotic Women

• Approximately 32% of all first fractures occur in the spine.⁷

• †Data are from 875 postmenopausal women with no prior vertebral or nonvertebral fracture randomized to the placebo group of the more trial. Average age of patient was 64.5 years.

Consequences of High Turnover with Negative Balance

• Conversion of plates to rods⁸
• Decreased trabecular width and bone volume⁸
• Resorption pits are stress risers that concentrate biomechanical strain, like a notch in a glass rod⁹
• Perforations result in loss of connectivity⁸

1. America's Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation.
   Washington, DC: National Osteoporosis Foundation; 2002:2,5-7.
2. Osteoporos Int. 1999;10:214-221.
3. N Engl J Med. 1986;314:1676-1686.
4. Data on file, Lilly Research Laboratories (EVI200011002).
5. JAMA. 1999;282:637-645.
6. Data on file, Lilly Research Laboratories (EVI199910005).
7. Data on File, Lilly Research Laboratories (EVI20090122).
8. J Clin Invest. 1983;72:1396-1409.
9. J Bone Miner Res. 2005;20:177-184.

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.

For additional information, please see the full Prescribing Information and Medication Guide.

---

EVISTA is a once-daily 60-mg tablet. Supplemental calcium and/or vitamin D should be added to diet if daily intake is inadequate.

Prescribing Information | Medication Guide | Safety Information and Boxed Warning | Site Map | Contact Us