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Low Dose Estrogen Approved for Prevention of Postmenopausal Osteoporosis
MADISON, N.J., July 17 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has approved the 0.3 mg and 0.45 mg dosage strengths of PREMARIN® (conjugated estrogens tablets, USP) for the prevention of postmenopausal osteoporosis. This approval is based on data from a prospective clinical study that found these low doses of PREMARIN to be as effective as the current standard dose in preventing postmenopausal bone loss in women with menopausal symptoms.
With this most recent action, FDA has issued four separate approvals in recent months pertaining to new low dose strengths of PREMARIN and PREMPRO™ (conjugated estrogens/medroxyprogesterone acetate tablets) -- PREMARIN 0.3 mg, PREMARIN 0.45 mg, PREMPRO 0.3 mg/1.5 mg, and PREMPRO 0.45 mg/1.5 mg. These new dosage strengths are all indicated for use by menopausal women for the treatment of moderate to severe hot flashes, moderate to severe vaginal dryness, and for the prevention of postmenopausal osteoporosis.
These approvals are consistent with the recommendation to prescribe low dose postmenopausal hormone therapy. Women should take the lowest effective dose of postmenopausal hormone therapy for the shortest duration consistent with treatment goals and risks for the individual woman. The FDA, other health experts, and Wyeth recommend that when used solely for the prevention of postmenopausal osteoporosis, hormone therapy should be considered only for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
Three of these low dose strengths are currently available: PREMARIN 0.3 mg, PREMARIN 0.45 mg, and PREMRPO 0.45 mg/1.5 mg. The company expects that PREMPRO 0.3 mg/1.5 mg will be available by the end of 2003.
"With this approval, women and clinicians have two additional low dose estrogen options to better individualize effective treatment for menopausal symptom relief and concomitant bone protection," says Victoria Kusiak, Vice President Global Medical Affairs, and North American Medical Director, Wyeth Pharmaceuticals.
Data supporting the efficacy of low doses of PREMARIN for the prevention of osteoporosis are based on a substudy of the Women's Health, Osteoporosis, Progestin, and Estrogen (HOPE) trial, a prospective, randomized, double-blind, placebo-controlled, multicenter study of 2,673 healthy postmenopausal women age 40 to 65 years. A total of 822 women participated in the bone substudy. The Women's HOPE bone data were published in the May 22/29, 2002 issue of the Journal of the American Medical Association (JAMA).
Postmenopausal estrogen therapy, which was first introduced more than 60 years ago, remains an important therapeutic option for menopausal women. Postmenopausal estrogen/hormone therapy is the only treatment approved by the FDA for the relief of menopausal symptoms and the concomitant prevention of postmenopausal osteoporosis.
Wyeth's hormone therapy products are prescribed more often than any other brand of postmenopausal hormone therapy.
What is the most important information a woman should know about PREMARIN® (a mixture of estrogen hormones) or PREMPRO™ (a combination of estrogens and a progestin)?
* Estrogens increase the chances of getting cancer of the uterus. A woman should report any unusual vaginal bleeding right away while taking these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Her 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, or strokes. * Using estrogens with or without progestins may increase a woman's chances of getting heart attacks, strokes, breast cancer, and blood clots. A woman and her health care provider should talk regularly about whether she still needs treatment with estrogens.
PREMARIN® is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning in or around the vagina; and to help reduce a woman's chances of getting osteoporosis (thin, weak bones).
PREMPRO™ 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 or around the vagina; and to help reduce a woman's chances of getting osteoporosis (thin, weak bones).
PREMARIN and PREMPRO should be used for the shortest duration consistent with a woman's treatment goals and risks. If a woman does 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 adverse events (>5%) for PREMARIN 0.3 mg or 0.45 mg or 0.625 mg that were statistically different than placebo included vaginal moniliasis, vaginitis, vaginal bleeding, dysmenorrhea, and leg cramps.
In a clinical trial, the most commonly reported adverse events (greater than or equal to 5%) for PREMPRO 0.45 mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg were mastaglia, vaginal bleeding, vaginal moniliasis, leg cramps, dysmenorrhea, breast enlargement, and vaginitis. In a clinical trial, there was no difference in the commonly reported adverse events (greater than or equal to 5%) for women taking PREMPRO 0.3 mg / 1.5 mg compared to those taking placebo.
PREMARIN and PREMPRO should not be used if a woman has unusual vaginal bleeding, has or had cancer of the breast or uterus, had a stroke or heart attack in the past year, has or had blood clots, has liver problems, is allergic to any of the ingredients in PREMARIN or PREMPRO, or thinks she may be pregnant.