Study Evaluating Efficacy and Safety of Two Low-dose Regimens of Premarin Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published
COLLEGEVILLE, Pa., July 13 /PRNewswire-FirstCall/ -- Wyeth
Pharmaceuticals, a division of Wyeth (NYSE:WYE) , announced the publication of data
that supported daily and twice-weekly use of PREMARIN (conjugated
estrogens) Vaginal Cream 0.5 g to relieve some of the bothersome
symptoms of moderate-to-severe vulvar and vaginal atrophy,
including painful intercourse (dyspareunia). This study evaluated
the efficacy of two low-dose regimens of conjugated estrogens (CE)
cream (0.5 g daily and twice weekly) using a double-blind,
placebo-controlled study design for 12 weeks followed by a 40-week
open-label phase. Endometrial safety for both dosing regimens was
also assessed in women who completed 52 weeks of therapy. These
study results are published in the July/August issue of Menopause:
The Journal of the North American Menopause Society.
In this study, dyspareunia was the most bothersome symptom at
baseline (57%) followed by vaginal dryness, itching and
burning.Unlike hot flashes or night sweats, signs and symptoms of
vaginal atrophy have been shown to increase over time in
postmenopausal women.
"Based on market research data, we understand that many
postmenopausal women are not discussing their symptoms with their
health care professionals," says Gloria Bachmann, M.D., lead study
author and director of the Women's Health Institute at the
University of Medicine and Dentistry of New Jersey-Robert Wood
Johnson Medical School, New Brunswick, N.J., and chief of the
OB/GYN service at the teaching hospital. "We are encouraged by this
52-week data that showed twice-weekly use of PREMARIN Vaginal Cream
was sufficient to provide relief from painful intercourse due to
menopause. The study also supported daily use of PREMARIN Vaginal
Cream 0.5 g to treat postmenopausal vaginal dryness. This
information should aid postmenopausal women and their health care
professionals in discussing whether and how they may treat vaginal
atrophy."
Study Design and Results:
In this multicenter clinical study, 423 postmenopausal women
(ages 45-80 years) with moderate-to-severe vaginal atrophy were
randomized to receive PREMARIN Vaginal Cream 0.5 g (equivalent to a
low-dose of CE cream 0.3 mg) or placebo once daily (21 days on/7
days off) or twice weekly for 12 weeks. Treatment regimens were
consistent within the 12-week and 40-week periods. The primary
endpoints of the study were changes in vaginal maturation index
(VMI; percentage of superficial cells), vaginal pH and severity of
participant-reported most bothersome symptom (vaginal dryness,
itching, burning or dyspareunia) at week 12.The study also
evaluated safety related to systemic effects of CE cream on
endometrial tissue during one year of therapy.
At week 12, improvements in VMI and vaginal pH with daily and
twice-weekly use of PREMARIN Vaginal Cream 0.5 g were significantly
greater relative to placebo (P<0.001). Results from the 12-week
phase also showed that both low-dose regimens of PREMARIN Vaginal
Cream (0.5 g daily and twice weekly) significantly improved the
most bothersome symptoms score versus placebo at 12 weeks (P less
than or equal to 0.001), including those for dyspareunia (P less
than or equal to 0.01).
After 52 weeks of therapy, with the same respective dosing
regimens as in the double-blind phase, results were similar to
those observed at week 12 and demonstrated the efficacy of PREMARIN
Vaginal Cream versus placebo. Endometrial safety was assessed in
women who completed the 52-week study period and had evaluable
endometrial biopsies. There were no reports of endometrial
hyperplasia or endometrial carcinoma in these women in either
regimen. In this study, the most common treatment emergent AE's
were headache, infection, arthralgia and vaginitis.
About PREMARIN Vaginal Cream
PREMARIN Vaginal Cream is used to treat menopausal changes in
and around the vagina and painful intercourse caused by these
changes.Menopause can cause changes in the vaginal tissue,
resulting in uncomfortable symptoms. PREMARIN Vaginal Cream treats
the underlying cause of many of these symptoms and can restore the
tissues that provide elasticity and lubrication with a low-dose and
low-cream volume. PREMARIN Vaginal Cream is only available by
prescription.
Important Safety Information:
What is the most important information you should know about
PREMARIN Vaginal Cream (an estrogen mixture)?
Estrogens may increase the chance of getting cancer of the
uterus.
Report any unusual vaginal bleeding right away while you are
using PREMARIN Vaginal Cream. Vaginal bleeding after menopause may
be a warning sign of cancer of the uterus (womb). Your health care
professional should check any unusual vaginal bleeding to find out
the cause.
Do not use estrogens with or without progestins to prevent heart
disease, heart attacks, strokes, or dementia.
Using estrogens, with or without progestins, may increase your
chance of getting heart attacks, strokes, breast cancer, and blood
clots. Using estrogens, with or without progestins, may increase
your chance of getting dementia, based on a study of women age 65
years or older. You and your health care professional should talk
regularly about whether you still need treatment with PREMARIN
Vaginal Cream.
PREMARIN (conjugated estrogens) Vaginal Cream is used after
menopause to treat menopausal changes in and around the vagina and
to treat painful intercourse caused by menopausal changes of the
vagina.
PREMARIN Vaginal Cream should not be used if you have unusual
vaginal bleeding, have or had cancer of the breast or uterus, had a
stroke or heart attack, have or had blood clots or liver problems,
are allergic to any of the ingredients in PREMARIN Vaginal Cream,
or think you may be pregnant.
The most commonly reported side effects of PREMARIN Vaginal
Cream include headache, infection, abdominal pain, accidental
injury, and vaginitis.
About Vulvar and Vaginal Atrophy
Women produce less estrogen after menopause. When estrogen
levels begin dropping, vaginal walls become thinner and less
lubricated, and some women experience vulvar and vaginal atrophy.
Vulvar and vaginal atrophy can result in vaginal irritation,
dryness, dyspareunia (painful sexual intercourse), discharge and
bleeding after sex.
About Dyspareunia
Dyspareunia, or pain experienced during sexual intercourse, can
be a bothersome symptom of vulvar and vaginal atrophy. Based on a
survey of 200 women transitioning through menopause, approximately
one in three reported experiencing dyspareunia. Dyspareunia
typically does not subside without treatment.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products
in the areas of women's health care, infectious disease,
gastrointestinal health, central nervous system, inflammation,
transplantation, hemophilia, oncology, vaccines and nutritional
products.
Wyeth is one of the world's largest research-driven
pharmaceutical and health care products companies. It is a leader
in the discovery, development, manufacturing and marketing of
pharmaceuticals, vaccines, biotechnology products, nutritionals and
non-prescription medicines that improve the quality of life for
people worldwide. The Company's major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.
The statements in this press release that are not historical
facts are forward-looking statements that are subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. These risks and
uncertainties include, among others, risks related to our proposed
merger with Pfizer, including satisfaction of the conditions of the
proposed merger on the proposed timeframe or at all, contractual
restrictions on the conduct of our business included in the merger
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in key business activities or any impact on our relationships with
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quarterly reports on Form 10-Q and annual report on Form 10-K,
particularly the discussion under the caption "Item 1A, Risk
Factors" in our Annual Report on Form 10-K for the year ended
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Commission on February 27, 2009. The forward-looking statements in
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Source: Wyeth Pharmaceuticals
CONTACT: Media Contacts: Gwen Fisher, Wyeth
Pharmaceuticals,
+1-484-865-5160; Douglas Petkus, Wyeth, +1-973-660-5218; or
Investor Contact:
Justin Victoria, Wyeth, +1-973-660-5340
Web Site: http://www.wyeth.com/
