No apparent increase in coronary heart disease for women who initiate hormone therapy

Wyeth Pharmaceuticals, a division of Wyeth, provides comment on a re- analysis of pooled data from both hormone therapy arms of the Women's Health Initiative (WHI) Study published today in the Journal of the American Medical Association.

The pooled analysis showed no apparent increase in coronary heart disease for women who initiate hormone therapy close to menopause.

The publication also reports a statistically nonsignificant trend toward a reduction in coronary heart disease among hormone therapy users within 10 years of menopause. Study authors also reported 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 with a nonsignificant trend for increasing risk across other age groups. Additionally, consistent with previous findings, an increase in the risk of stroke for women taking hormone therapy was confirmed in this pooled analysis.

"These pooled findings with respect to coronary heart disease may be reassuring to newly menopausal women," says Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs for Wyeth Pharmaceuticals. "Hormone therapy remains a good health care choice for the appropriate woman seeking the relief of moderate to severe menopausal symptoms, including hot flashes, night sweats and vaginal atrophy and the prevention of postmenopausal osteoporosis. Hormone therapy should not be used for the prevention of cardiovascular disease.

"Furthermore, the overall findings of this pooled analysis of the WHI are consistent with major observational studies, such as the Nurses' Health Study," adds Dr. Camardo. "The overall risk/benefit ratio with hormone therapy may depend on many factors, including the type of therapy a woman chooses, such as estrogen or estrogen plus progestin, as well as a woman's age or years since menopause when therapy was initiated."

The findings reported in this publication are based on prespecified analyses of data from the WHI, 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(R) [conjugated estrogens tablets, USP]) and oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) (PREMPRO(R) [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.

The absolute risk for cardiovascular disease associated with hormone therapy use depends on the background rate, which increases with various risk factors, including age, personal health history and family history, among others. For most early menopausal women, the absolute risk of cardiovascular disease is low. Current hormone therapy labeling includes a warning about the risks of cardiovascular disease, and advises against using hormone therapy for the prevention of cardiovascular disease.

Wyeth continues to support the use of hormone therapy and recommends that it be used at the lowest effective dose for the appropriate duration consistent with treatment goals and risks for the individual woman. Hormone therapy is not appropriate for all women. Women experiencing menopausal symptoms are encouraged to speak with their health care professionals to determine whether hormone therapy might be the right treatment option for them.

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%) 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%) 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%) 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.