By John Otrompke
SAN DIEGO -- October 7, 2009 -- An experimental drug may cause fewer hot flushes in postmenopausal women than some products already on the market, according to researchers here at the 20th Annual Meeting of the North American Menopause Society (NAMS).
Arzoxifene, an experimental drug designed for use in postmenopausal women, was not associated with hot flushes in 1 trial and did not significantly increase the incidence of hot flushes over placebo in another study, reported Wulf H. Utian, MD, Case Western Reserve School of Medicine; and the Cleveland Clinic, Cleveland, Ohio, and colleagues.
"In the FOUNDATION trial, women randomised to placebo experienced 18 hot flushes in the study, compared with 21 on arzoxifene," said Dr. Utian in a presentation on October 2. "In the NEXT trial, 27 patients randomised to raloxifene experienced new or worsening episodes of hot flushes, compared with 11 in the arzoxifene arm."
Certain selective oestrogen-receptor modulators (SERMs) in clinical use, such as raloxifene and tamoxifen, increase the frequency and severity of hot flushes, as do some drugs in late-stage clinical development, such as bazedoxifene and lasofoxifene. In this study, arzoxifene, another SERM in clinical development, was not associated with hot flushes.
In FOUNDATION, a 2-year, placebo-controlled trial, hot flushes were reported by 47% of women at baseline. The FOUNDATION study randomised 331 postmenopausal women (mean age 55 years) with normal to low bone mass to raloxifene or placebo. Women reported new or worsening hot flushes at similar frequencies regardless of treatment group, and most incidents were in the first 3 months of study. In the placebo arm, 17.1% experienced new hot flushes, compared with 17.2% in the arzoxifene arm.
In the NEXT study, a 1-year trial that randomised 320 postmenopausal women (mean age 63 years) to arzoxifene 20 mg/day or raloxifene, hot flushes were reported by 7% of women at baseline. At 3 months, the raloxifene group experienced almost twice as many new or worsening hot flushes as the arzoxifene group. Additionally, reports of vasomotor events were lower in the arzoxifene group at 6 months, according to the researchers.
Funding for this study was provided by Eli Lilly and Company.
[Presentation title: Effect of Arzoxifene on Hot Flushes in Postmenopausal Women. Abstract S-22]
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