Lasofoxifene Improves Symptoms of Vaginal Atrophy in Postmenopausal Women: Presented at NAMS

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Title: Lasofoxifene Improves Symptoms of Vaginal Atrophy in Postmenopausal Women: Presented at NAMS
URL: http://www.pslgroup.com/dg/22DDA2.htm
Doctor's Guide
September 30, 2008

By Deborah Brauser

ORLANDO, Fla -- September 30, 2008 -- Lasofoxifene, a selective oestrogen receptor module (SERM), demonstrated significant improvements in vaginal atrophy in osteoporotic postmenopausal women by decreasing vaginal pH and improving the vaginal-cell maturation index, according to trial results presented here at the North American Menopause Society (NAMS) 19th Annual Meeting.

Steven Goldstein, MD, New York University School of Medicine, New York, New York, reported the results of a 3-year, phase 3 study of lasofoxifene in a late-breaking poster presentation here on September 25.

In the Postmenopausal Evaluation and Risk-Reduction With Lasofoxifene (PEARL) study, 8,556 postmenopausal women with osteoporosis were given calcium (1,000 mg) and vitamin D (400-800 IU), and then randomly assigned to lasofoxifene dosage groups of either 0.25 or 0.5 mg/d, or placebo. All subjects were aged 59 to 80 years.

A subset of 326 subjects from the PEARL trial was further assessed for vaginal pH and maturation index at baseline, 12 months, 24 months, and 36 months.

At the end of the trial, lasofoxifene treatment in the subset decreased pH log units -0.27 (95% CI, -0.38 to -0.16; P = .001) for the 0.25-mg dose and -0.13 (95% CI, -0.25 to -0.02; P = .001) for the 0.5-mg dose, compared with placebo. In addition, a significant effect was seen at 12 months in both dosage groups and was sustained throughout the study.

Both lasofoxifene groups also showed positive effects on the vaginal-cell maturation index, with an increase in superficial cells relative to parabasal cells at 12 months and sustained through 3 years. Additionally, shifts towards a lower proportion of parabasal cells, and greater proportions of intermediate and superficial cells were observed after both lasofoxifene treatments, while the relative proportion of parabasal, intermediate, and superficial cells remained generally unchanged in the placebo group.

Said Dr. Goldstein, "This really is the first SERM that seems to have a positive effect on objective findings in the vagina. So, whereas, in my clinical practice, pretty much every patient on raloxifene is also on an intravaginal oestrogen, a significant number of women theoretically on a drug like this would not need a second drug in the vagina because of the improvements in the vaginal effects."

"Here's a SERM that has a different action in the vagina than the ones we're familiar with," added Dr. Goldstein.

Funding for this trial was provided by Pfizer, Inc.

[Presentation title: Vaginal Effects of Lasofoxifene: 3-Year Results From the PEARL Trial. Abstract LB-5]

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