Collegeville, Pa., June 20, 2007 -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), provides comment on the Women's Health Initiative (WHI) Coronary Artery Calcium Study published today in The New England Journal of Medicine (NEJM). The study found that younger menopausal women (aged 50-59) who received a standard dose of oral conjugated estrogens had significantly less coronary artery calcification at the end of the study period compared with those taking placebo. Coronary artery calcification is a marker of plaque in the arteries and a predictor of future cardiovascular events.
"In the five years since the WHI study ended, new data have emerged that help put the initial findings into perspective. These results showed that in these younger menopausal women, estrogen therapy reduced calcified plaque buildup in the arteries," says Howard Hodis, M.D., Professor of Medicine and Preventive Medicine; Director, Artherosclerosis Research Unit, University of Southern California. "These data support initiation of estrogen therapy, where indicated when a woman first enters menopause and begins experiencing symptoms and bone loss."
Wyeth is unaware of any coronary artery calcification data for women taking estrogen plus progestin. The investigators did not study coronary artery calcification in women who were over 60 at the beginning of the study.
These findings are consistent with a recent re-analysis of pooled estrogen alone and estrogen plus progestin data from the WHI study, published April 4, 2007, in the Journal of the American Medical Association (JAMA). This study found no apparent increase in coronary heart disease for women who initiated hormone therapy within 10 years of menopause; and a statistically significant reduction in total mortality among women aged 50-59 in the group receiving hormone therapy compared with those in the placebo group.
"The recent pooled analysis published in JAMA provides reassurance about coronary artery disease to newly menopausal women considering estrogen plus progestin therapy or estrogen alone therapy for symptom relief and prevention of postmenopausal bone loss. The data published today in NEJM provide additional evidence for women considering estrogen alone therapy," says Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs for Wyeth Pharmaceuticals. "We hope this information can help clarify the clinical perspective for women who choose hormone treatment for menopausal symptoms and prevention of osteoporosis."
The authors conclude, "Hormone therapy should not be initiated (or continued) for the express purpose of preventing cardiovascular disease in either younger or older postmenopausal women." The authors further state, "The current recommendations from many organizations that hormone therapy be limited to the treatment of moderate to severe menopausal symptoms, with the lowest effective dose used for the shortest duration necessary, remain appropriate." Wyeth continues to support the use of hormone therapy. Hormone therapy is not appropriate for all women. Women experiencing menopausal symptoms are encouraged to speak with their health care professional to determine whether hormone therapy might be the right treatment option for them.
The WHI was a large-scale study sponsored by the National Institutes of Health that was designed to evaluate hormone therapy, dietary modification, calcium and vitamin D as preventive therapies for menopausal women. The hormone therapy arms were designed to assess select long-term risks and benefits of hormone therapy. The WHI studied conjugated estrogens (0.625 mg) (PREMARIN® [conjugated estrogens tablets, USP]) and oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) (PREMPRO™ [conjugated estrogens/medroxyprogesterone acetate tablets]). PREMARIN and PREMPRO are the most widely prescribed hormone therapy products in the United States and offer significant clinical experience and the largest safety database available among hormone therapy products, providing extensive information to assist health care professionals in making appropriate treatment recommendations.
What is the most important information you should know about PREMARIN (estrogens) or PREMPRO (a combination of estrogens and a progestin)"
- Estrogens increase the chances of getting cancer of the uterus.
- Report any unusual vaginal bleeding right away while you are taking these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider 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 chances of getting heart attacks, strokes, breast cancer and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women aged 65 years or older. You and your health care provider should talk regularly about whether you still need treatment with estrogens.
PREMARIN® (conjugated estrogens tablets, USP) is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching and burning in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).
PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) is used after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching and burning in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). PREMARIN and PREMPRO should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. If using PREMARIN or PREMPRO only to treat your symptoms of vaginal dryness, consider topical therapies first. If you do not have symptoms, non-estrogen treatments should be carefully considered before taking PREMARIN or PREMPRO solely for the prevention of postmenopausal osteoporosis.
In a clinical trial, the most commonly reported (=5 percent) side effects that occurred more frequently with PREMARIN than with placebo were vaginitis due to yeast or other causes, vaginal bleeding, painful menstruation and leg cramps.
In a clinical trial, the most commonly reported (=5 percent) side effects that occurred more frequently with PREMPRO 0.45 mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg than with placebo were breast pain/enlargement, vaginitis due to yeast or other causes, leg cramps, vaginal spotting/bleeding and painful menstruation. In a clinical trial, there was no difference in the commonly reported (=5 percent) side effects for women taking PREMPRO 0.3 mg/1.5 mg compared with those taking placebo.
PREMARIN and PREMPRO 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 in the past year, have or had blood clots, have liver problems, are allergic to any of the ingredients in PREMARIN or PREMPRO, or think you may be pregnant. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
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 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.
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