Bazedoxifene Demonstrates No Significant Increase of Vasomotor Effects in Nonflushing Postmenopausal Women: Presented at NAMS

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Title: Bazedoxifene Demonstrates No Significant Increase of Vasomotor Effects in Nonflushing Postmenopausal Women: Presented at NAMS
URL: http://www.pslgroup.com/dg/22DE82.htm
Doctor's Guide
September 30, 2008

By Deborah Brauser

ORLANDO, Fla -- September 30, 2008 – Bazedoxifene, a selective oestrogen receptor modulator (SERM), did not increase the incidence of vasomotor effects (hot flushes) in postmenopausal women, according to clinical-trial data presented here at the North American Menopause Society (NAMS) 19th Annual Meeting.

Bazedoxifene is undergoing clinical development for the prevention and treatment of postmenopausal osteoporosis, but this trial was specifically designed to evaluate the product's vasomotor effects in healthy, nonflushing postmenopausal women, noted Gloria Bachmann, MD, University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey.

During the multicentre, double-blind trial, 487 nonflushing women (based on the absence of flushing during the 2-week screening period) aged 65 or younger were randomised to receive either 5-, 10-, or 20-mg doses of bazedoxifene; a 60-mg dose of raloxifene; or a placebo once daily. Supplemental elemental calcium of 600 mg/day was also administered to all groups.

Two other recent studies have produced results that differ from those of Dr. Bachmann's study.(1,2) She noted that the discrepancies appear to be due to the selection criteria. "I think it's the methodology that made the difference," she reported at a poster session here on September 25. "We were able to clearly take and evaluate a nonflushing population of women because of our 2-week run-in [phase]. Women who had hot flushes during those 2 weeks in the placebo-induced situation were eliminated, giving us a group that was truly nonflushing for our study."

Dr. Bachmann also said that in the earlier studies, the majority of the reported incidences were mild to moderate.

The primary endpoint in the current study was the percentage of subjects reporting hot flushes at any time during the 12-week treatment period. The self-reporting was carried out through the use of daily diary cards. Effects on biochemical markers of bone metabolism and lipid parameters were also evaluated.

At the trial's end, none of the active treatment groups was statistically different from placebo in the percentage of subjects reporting hot flushes. The incidence of hot flushes reported by the placebo-treated group was 25.5%, by the bazedoxifene 5-mg group at 26.0%, 33.7% from the bazedoxifene 10-mg group, 27.6% at 20 mg bazedoxifene, and 21.4% with raloxifene.

In addition, there were no significant differences from placebo in the mean number or severity of hot flushes during secondary-endpoint evaluations at week 12 and over each 4-week period.

"I think what's most exciting is that with this new SERM, we're not going to have to deal with the increased risk of vasomotor symptoms for women who eventually use it for osteoporosis bone indications," stated Dr. Bachmann. "It's going to give us a profile that is very favourable."

Significantly greater (P < .05) reductions from baseline were observed compared with placebo in levels of urinary N-telopeptide in the bazedoxifene 10-mg dose group and the raloxifene group; in levels of urinary C-telopeptide with all bazedoxifene doses and raloxifene; and in levels of serum osteocalcin with bazedoxifene 10- and 20-mg doses and raloxifene.

In addition, treatment with bazedoxifene demonstrated beneficial effects on the lipid profile. The bazedoxifene 20-mg and raloxifene groups had significantly greater (P < .05) reductions from baseline in levels of total and low-density lipoprotein cholesterol when compared with the placebo group. In high-density lipoprotein cholesterol evaluations, there were no significant changes.

"Obviously, the safety and efficacy of this product are most important, but the results from this study are also valuable for the issues of vasomotor symptomatology," concluded Dr. Bachmann.

Funding for this trial was provided by Wyeth Pharmaceuticals Inc.

1. Miller PD et al. J Bone Miner Res. 2008;23:525-535.

2. Silverman SL et al. [Published online ahead of print July 28, 2008]. J Bone Miner Res. doi:10.1359/JBMR.080710.

[Presentation title: Vasomotor Effects of Bazedoxifene in Nonflushing Postmenopausal Women. Abstract P-10]

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