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EVISTA is a prescription
medication for the prevention and treatment of
osteoporosis (thin, weak bones) in women after
menopause. EVISTA is also for women who have already
been diagnosed with osteoporosis. It treats osteoporosis
by helping make bones stronger and less likely to break.
By increasing bone mass and strengthening your bones,
EVISTA can reduce the risk of fracture, which can rob
you of your independence and mobility. As well
preventing and treating osteoporosis, Evista also lowers
cholesterol. It lowers total cholesterol by about 7%
and LDL (bad) cholesterol by about 11%. It does not
change HDL (good) cholesterol. In clinical studies,
women taking Evista had no increased risk of breast
SIDE EFFECTS that may occur while
taking this medicine include hot flashes or leg cramps.
If they continue or are bothersome, check with your
doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if
you experience swelling of hands, feet, or legs; breast
pain or enlargement; unusual weight gain; or abnormal
vaginal bleeding or spotting. CONTACT YOUR DOCTOR
IMMEDIATELY if you experience pain in your calves, leg
swelling, sudden chest pain, shortness of breath, or
changes in vision. If you notice other effects not
listed above, contact your doctor, nurse, or pharmacist.
Some medicines or medical
conditions may interact with this medicine. INFORM YOUR
DOCTOR OR PHARMACIST of all prescription and
over-the-counter medicine that you are taking. Inform
your doctor of any other medical conditions, allergies,
pregnancy, or breast-feeding. USE OF THIS MEDICINE IS
NOT RECOMMENDED if you have a history of blood clots.
Contact your doctor or pharmacist if you have any
questions or concerns about taking this medicine.
Being immobile for long periods of
time while taking this medicine may increase your risk
of blood clots. During long periods of travel, get up
and move around as often as possible. DO NOT SHARE THIS
MEDICINE with others for whom it was not prescribed.
Evista has been evaluated in three phase III trials
in 1,764 postmenopausal women. These studies primarily
investigated the effect of Evista on BMD of the lumbar
spine and proximal femur. Additional endpoints included
effects on biochemical markers of bone turnover, and
serum lipids. Only one of these studies has been
published in full. Data provided by the two unpublished
studies are generally consistent with the following
The fully published European, double-blind,
placebocontrolled trial randomised 601 postmenopausal
women to Evista 30mg/day (n=152), 60mg/day (n=152),
150mg/day (n=147) or placebo (n=150).5 Compared with
placebo, two years treatment with Evista 60mg/day
increased BMD at the lumbar spine,
hip, femoral neck & total body, by 1-2%.
decreased the serum levels of
biochemical markers of bone turnover.
decreased the serum concentrations
of total and LDL cholesterol.
Data from the MORE study (n = 7,705) demonstrate that
treatment with evista 60mg for 3 years, reduced the
risk of a new vertebral fracture in osteoporotic
postmenopausal women by 30%. A reduction in the risk of
hip or wrist fractures has not been demonstrated.
1. Eli Lilly and Company Limited. Evista. Summary of
Product Characteristics 2000.
2. Fordham J. Treatment of established osteoporosis.
Pharm J 2000;264:593-6.
3. Eastell R. Treatment of postmenopausal osteoporosis.
N Engl JMed 1998;338:736-46.
4. Osteoporosis. Clinical guidelines for prevention and
treatment. Royal College of Physicians of London. 1999.
5. Delmas P, Bjarnason N, Mitlak B, Ravoux A, Shah A, et
al.Effects of raloxifene on bone mineral density, serum
cholesterol concentrations, and uterine endometrium in
women. N Engl J Med 1997;337:1641-7.
6. Walsh BW, Kuller LW, Wid RA, Paul S, Farmer M, et al.
Effects of raloxifene on serum lipids and coagulation
factors in healthy postmenopausal women. JAMA
7. Draper M, Flowers D, Huster W, Neild J, Harper K, et
al. A controlled trial of raloxifene (LY139481) HCl:
impact on bone turnover and serum lipid profile in
healthy postmenopausal women. J Bone Miner Res
8. Ettinger B, Black D, Mitlak B, Knickerbocker R,
Nickelsen T. Reduction of vertebral fracture risk in
postmenopausal women with osteoporosis treated with
raloxifene. JAMA 1999;282:637-45.
9. Davies G, Huster W, Plouffe L, Lakshmanan M. Adverse
events reported by postmenopausal women in controlled
trials with raloxifene. Obstet Gynecol 1999;93:558-65.
10. Cummings S, Eckert S, Krueger K, Grady D, Powles T,
et al. The effect of raloxifene on risk of breast cancer
in postmenopausal women. JAMA 1999;281:2189-97.
11. Cohen F, Watts S, Shah A, Akers R, Plouffe L.
Uterine effects of 3-year raloxifene therapy in
postmenopausal women younger than age 60. Obstet Gynecol
12. Goldstein S, Scheele W, Rajagopalan S, Wilkie J,
Walsh B, et al. A 12-month comparative study of
raloxifene, estrogen, and placebo on the postmenopausal
endometrium. Obstet Gynecol