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Women's Health Initiative Study Data Show No Increased Risk of ...

...Wyeth provided the medications used in the HT portion of the WHI study, but did not have a role in the analysis or reporting of study findings.

The HT portion of the WHI study enrolled approximately 27,000 women between 1993 and 1998.

The estrogen-plus-progestin sub-study began with more than 16,000 women randomized to estrogen-plus-progestin or placebo.

The estrogen-alone sub-study enrolled more than 10,700 hysterectomized women.

The primary efficacy endpoint of WHI was the prevention of CHD, and the primary safety endpoint was the risk of breast cancer.

The secondary endpoints included hip fracture, colorectal cancer, stroke, pulmonary embolism and death from other causes.

The WHI was not designed to assess the relief of menopausal symptoms, such as hot flashes, night sweats and dryness from vaginal atrophy - the primary reasons women initiate therapy.

The estrogen-plus-progestin study arm of the WHI concluded in July 2002; the estrogen-alone arm concluded in March 2004.

Sub-study participants were then asked to enter into a follow-up phase.

It is important to note that the estrogen-alone sub-study of WHI evaluated the 0.625 mg strength of Premarin; today, a number of lower doses of the Premarin Family of Products are widely available, including Premarin 0.3 mg and 0.45 mg and About Estrogen-Alone Therapy Both estrogen-alone and estrogen-plus-progestin therapy ...

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