Wyeth: Latest WHI data links Premarin to reduced incidence of fracture and fewer cases of breast cancer
Wyeth: Latest WHI data links Premarin to reduced incidence of fracture and fewer cases of breast cancer
MADISON, N.J., April 13, 2004 -- Data from the estrogen-alone study arm of the Women's Health Initiative (WHI) associate estrogen therapy with a reduction in fractures and fewer cases of breast cancer than placebo, according to Wyeth Pharmaceuticals, a division of Wyeth.
Wyeth says the risk of stroke seen with estrogen in the WHI is consistent with information in the existing product label.
According to the study authors, "Women considering initiating CEE (conjugated equine estrogens) should be counseled about an increased risk of stroke, but can be reassured about no excess risk of heart disease or breast cancer for at least 6.8 years of use." The authors also state, "The WHI estrogen-alone trial provides strong evidence that CEE reduces the risk of hip, clinical vertebral and other fractures."
The average age of the women in the estrogen-alone study group was 63 at the time of enrollment. In preliminary sub-analyses, it appears that the risks monitored in WHI were lower for women ages 50 - 59 and increased with age. This is important since the average age of a woman at the time of hysterectomy is 42. While these results should be interpreted with caution, they appear to suggest that CEE may have a more favorable risk profile for younger versus older women.
Wyeth is encouraged by the study findings and will work closely with the U.S. Food and Drug Administration (FDA) to include them in the product label for Premarin (conjugated estrogens tablets, USP).
The report published today addresses the use of estrogen therapy as a long-term preventive agent and suggests an overall balance of benefits and risks. However, this assessment does not take into account the FDA-approved benefits of estrogen therapy for the relief of moderate to severe menopausal symptoms such as hot flashes, night sweats, and vaginal dryness, and the prevention of postmenopausal osteoporosis.
Specifically, the WHI data show that per 10,000 women per year, when compared with placebo, estrogen is associated with:
- 12 additional cases of stroke (39% higher). This finding is consistent with the information in the current Premarin labeling.
- 56 fewer cases of total osteoporotic fracture, including 6 fewer cases of hip fracture and 6 fewer cases of vertebral fracture (30-39% lower)
- 7 fewer cases of breast cancer (23% lower)
Estrogen-alone is most commonly prescribed to treat menopausal symptoms and prevent osteoporosis in women who have had a total hysterectomy (surgery to remove a woman's uterus and ovaries).
In addition, up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. In fact, approximately 35 million American women of menopausal age are at risk for osteoporosis and low bone mass, characterized by fragile bones and fracture susceptibility.
Wyeth says it is important to note that the WHI evaluated the 0.625 mg strength of Premarin; today, a number of lower doses of Premarin are widely available. Estrogen therapy should be prescribed at the lowest dose for the shortest duration consistent with treatment goals and risks for the individual woman.
Wyeth plans to distribute reprints of the study publication to facilitate the timely counseling of patients by physicians. The Company is also providing an online resource (www.estrogeninfo.com), where clinicians and women can get more information on this announcement from a variety of authoritative sources.
Source: Wyeth www.wyeth.com
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