Wednesday December 10, 2:55 pm Eastern Time
Company Press Release
SOURCE: Wyeth-Ayerst Laboratories
Raloxifene Less Effective Than Estrogen for Prevention of
Osteoporosis Effect on Fracture Risk Not Yet Known
Premarin(R) (conjugated estrogens tablets, USP) Delivers Multiple Health
Benefits
PHILADELPHIA, Dec. 10 /PRNewswire/ -- While today's market clearance of raloxifene by the U.S. Food and
Drug Administration (FDA) may offer another alternative therapy for the prevention of osteoporosis, raloxifene will
not be a substitute for the multiple health benefits millions of American women receive from estrogen replacement
therapy (ERT) after menopause. Premarin(R) (conjugated estrogens tablets, USP), which is the most prescribed
medication in the United States, will retain its place as the leading medication for the prevention and management of
osteoporosis in postmenopausal women. Nearly ten million American women currently take Premarin.
''Based on data comparing raloxifene and Premarin, I expect that Premarin will remain the first-line treatment for the
prevention of osteoporosis in postmenopausal women,'' said William C. Andrews, M.D., Professor Emeritus,
Eastern Virginia Medical School. ''There is nothing in the clinical data to suggest that raloxifene can substitute for
the multiple benefits of Premarin. However, raloxifene may be an option for the small number of women for whom
estrogen is contraindicated.''
Limited Raloxifene Data
Data presented at the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on November 20, 1997
comparing Premarin to raloxifene and placebo, indicated that bone mineral density improvements were significantly
better for Premarin than raloxifene. Over the 24 months of the study, bone mineral density at the hip increased three
times more in patients on Premarin than those receiving raloxifene. While Premarin continued to show a positive
effect on bone mineral density throughout the entire 24 months, raloxifene showed bone mineral density declining
after 18 months of use.
The Committee generally characterized raloxifene's bone data as only modestly effective. They also expressed desire
to see fracture data -- which were not available -- and raised questions about the long-term effects of therapy with
respect to heart disease, cognitive function, and breast cancer. Only limited data with no comparison to estrogen
were presented at the advisory committee meeting concerning raloxifene's effect on breast tissue. Several experts
noted that safety data were far too limited and preliminary to attribute any potential breast-protective effect to
raloxifene.
In addition, hot flashes occurred five to nine times more frequently with raloxifene compared to Premarin(R)
(conjugated estrogens tablets, USP). The primary reason women seek medical treatment at the time of menopause is
for relief of vasomotor symptoms, such as hot flashes, night sweats, and vaginal dryness all of which can affect a
woman's sense of well-being and sexual intimacy. Furthermore, raloxifene failed to increase HDL or ''good
cholesterol'' levels.
''The FDA Advisory Committee reiterated that Premarin provides women with a range of health benefits for today
and tomorrow,'' said Marc W. Deitch, M.D., Senior Vice President, Medical Affairs, Global Medical Director,
Wyeth-Ayerst Laboratories. ''Premarin has a 55-year history of use by millions of women, and researchers continue
to discover more benefits about Premarin every day.'' Premarin is indicated for vasomotor symptoms and the
prevention and management of osteoporosis in postmenopausal women. It is the most prescribed medication in the
United States.
Premarin is being studied in the Women's Health Initiative (WHI) national trial involving more than 27,500 women.
WHI is designed to examine the impact of estrogen replacement therapy or hormone replacement therapy on heart
disease, cancer and osteoporosis over a period of 14 years. Wyeth-Ayerst also sponsors the Heart and
Estrogen-progestin Replacement Study (HERS), as well as the Women's Health Initiative Memory Study
(WHI-MS), which is investigating the use of ERT/HRT in Alzheimer's disease.
Contraindications
Some women should not take estrogen replacement therapy (ERT). A woman should make sure her doctor or health
care provider is aware of her complete personal family history before taking ERT. The history should include
instances of breast cancer, breast lumps, abnormal vaginal bleeding, abnormal blood clotting, severe headache,
dizziness, and liver disease. Women who are pregnant should not take ERT. Estrogens have been reported to
increase the risk of cancer of the uterus in postmenopausal women. If women have had a hysterectomy they don't
have this risk. Adding the hormone progestin to estrogen greatly reduces the risk.
Wyeth-Ayerst Laboratories, a division of American Home Products Corporation (NYSE: AHP - news), is a major
research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular
and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines, and generic
pharmaceuticals. As a world leader in women's health care, the company is committed to improving health care
options available to women through ongoing research efforts and patient education programs.
Wyeth-Ayerst is the first U.S. company with a major research facility devoted exclusively to women's health. The
Wyeth-Ayerst Women's Health Research Institute is actively engaged in research that addresses the health care needs
women face during all phases of their lives.
American Home Products is one of the world's largest research-based pharmaceutical and health care products
companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and
over-the-counter medications. It is also a global leader in vaccines, biotechnology, agricultural products, animal
health care, and medical devices.
The statements in this press release that are not historical facts are forward-looking statements that involve risks and
uncertainties including those detailed from time to time in AHP's periodic reports, including quarterly reports on
Form 1O-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results
may differ from the forward-looking statements.
SOURCE: Wyeth-Ayerst Laboratories
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