Newly Published Study Demonstrates Sustained Efficacy of Evista -raloxifene HCl- in Reducing Risk of Spinal Fractures

     
BW20021001002239  20021001T131010Z UTC


( BW)(ELI-LILLY-&-CO)(BC43) Newly Published Study Demonstrates
Sustained Efficacy of Evista -raloxifene HCl- in Reducing Risk of
Spinal Fractures

    Business Editors
    UK REGULATORY NEWS

    INDIANAPOLIS--(BUSINESS WIRE)--Oct. 1, 2002--

       Confirming That Evista is a Proven, Non-hormonal Option
                   to Protect Bones After Menopause

Findings from the Multiple Outcomes of Raloxifene Evaluation (MORE)
study, a prospective, randomized, placebo-controlled trial involving
more than 7,700 women with osteoporosis, have shown conclusively that
Evista (raloxifene HCl) has continued efficacy in reducing a woman's
risk of spinal fractures through four years of treatment. Importantly,
the results which are published in the in the October issue of the
Journal of Clinical Endocrinology and Metabolism(1), show that Evista
(raloxifene HCl, 60 mg/day) exhibits sustained efficacy in reducing
the risk of spinal fractures. Specifically, Evista reduced the risk of
new spinal fractures by 55 percent in the first three years of the
study in women who had not yet suffered a fracture, and this decrease
was sustained at 50 percent in the fourth year of treatment(1).

Further evidence of sustained efficacy was demonstrated in women who
had already suffered a vertebral fracture. Evista reduced the risk of
new spinal fractures among this group of women by 30 percent in the
first three years and 38 percent in the fourth year(1).

"Evista has demonstrated that its ability to prevent fractures is just
as strong in the fourth year as in the earlier years of treatment,"
said Per Cantor, MD, Medical Director, Lilly. "Results from this four
year, evidence-based trial are particularly relevant, given the
recently released findings from the Women's Health Initiative trial.
The MORE study demonstrates that with Evista, women and physicians
have a proven alternative to hormone replacement therapy (HRT) to
protect women's bone health after menopause."

"The comprehensive analysis of the four-year data is significant,
because it confirms raloxifene's ability to give long-term, consistent
protection to postmenopausal women at risk of spinal fracture," said
Professor Pierre Delmas, MD, PhD, study author and Professor of
Medicine and Rheumatology at the University Claude Bernard of Lyon,
France. "Spinal fractures are the most common type of fracture
associated with osteoporosis and one in three women, 50 years or
older, experience spinal fractures related to osteoporosis--with or
without symptoms."

Additional analyses of four-year data from the MORE osteoporosis study
showed continued evidence that Evista is safe for the breast(2),
uterus, and the cardiovascular system(3).

Side effect information

No medicine is right for everyone, and Evista is no exception. It is
contraindicated for women who are, or can become pregnant, are
breast-feeding, have severe liver problems, or have blood clots
requiring medical treatment. A rare, but serious side effect of Evista
is blood clots in the veins, occurring with similar frequency to that
associated with HRT. The most commonly reported side effects are hot
flashes and leg cramps. However, most women taking Evista do not get
these symptoms.

Further information

Lilly, a leading innovation driven corporation, is developing a
growing portfolio of best-in-class pharmaceutical products by applying
the latest research from its own worldwide laboratories, and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, USA, Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs.

Evista(R) (raloxifene hydrochloride, Lilly)

References:

(1) Delmas PD, et al. Multiple Outcomes of Evista Evaluation (MORE)
Investigators. Efficacy of Evista on vertebral fracture risk reduction
in postmenopausal women with osteoporosis: Four-year results from a
randomized clinical trial. The Journal of Clinical Endocrinology and
Metabolism 2002; 87: 3609-17

(2) Cauley JA et al. Continued breast cancer risk reduction in
postmenopausal women treated with Evista: 4-year results from the MORE
trial. Multiple outcomes of Evista evaluation. Breast Cancer Res Treat
2001; 65: 125-34.

(3) Barrett-Connor E, et al. The MORE Investigators (Multiple Outcomes
of Evista Evaluation). JAMA 2002; 287: 847-57

   Short Name: Lilly (Eli) & Co
   Category Code: MSC
   Sequence Number: 00000875
   Time of Receipt (offset from UTC): 20021001T133355+0100

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    CONTACT: Eli Lilly and Company
             Sondra McQueary, +1-317/276-1209
             Angela Sekston, +1-317/277-8503
             Frances Beves, [phone] 

    KEYWORD: INDIANA FRANCE UNITED KINGDOM INTERNATIONAL EUROPE
    INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL PRODUCT 
    SOURCE: Lilly (Eli) & Co


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