Bazedoxifene/Conjugated Oestrogens Reduce Sleep Disturbances in Postmenopausal Women: Presented at NAMS

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Title: Bazedoxifene/Conjugated Oestrogens Reduce Sleep Disturbances in Postmenopausal Women: Presented at NAMS
URL: http://www.pslgroup.com/dg/22DD36.htm
Doctor's Guide
September 29, 2008

By Deborah Brauser

ORLANDO, Fla -- September 29, 2008 -- Bazedoxifene/conjugated oestrogens (BZA/CE), a tissue-selective oestrogen complex, significantly improve sleep issues in postmenopausal women, according to results from a phase 3 clinical study presented here at the North American Menopause Society (NAMS) 19th Annual Meeting.

Lead investigator Holly Yu, MSPH, Wyeth Research, Collegeville, Pennsylvania, reported the favourable findings in a clinical poster session here on September 25.

In this multicentre, double-blind trial, Yu and her team randomised 318 postmenopausal women to receive once-daily oral doses of either BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo for 12 weeks. All subjects were 40 to 65 years of age with an intact uterus and experiencing at least 7 moderate to severe hot flushes per day (or at least 50 per week).

The subjects assessed and recorded sleep parameters and symptoms at baseline and at week 12 using 2 self-administered questionnaires: the Medical Outcomes Study (MOS) sleep scale and the Menopause-Specific Quality of Life (MENQOL) questionnaire. Overall treatment satisfaction was also assessed at week 12 using the Menopause Symptoms-Treatment Satisfaction Questionnaire (MS-TSQ).

At trial's end, results showed that both doses of BZA/CE resulted in significant improvements (P < .001) in the mean change from baseline in the MOS sleep scale for time to fall asleep, sleep adequacy, sleep disturbance, and sleep problems indices I and II compared with placebo. Improvements (P < .001) were also noted in mean MENQOL vasomotor and total scores.

In the MS-TSQ, subjects reported significantly greater overall satisfaction with BZA 20 mg/CE 0.45 mg (73.5%) and BZA 20 mg/CE 0.625 mg (78.2%) compared with placebo-treated subjects (44.4%; P < .001).

Treatments with BZA/CE in either dosing group were also associated with greater satisfaction with sleep quality (P < .001), ability to control hot flashes during the day or night (P < .001), effect on mood or emotions (P < .05), and tolerance to side effects compared to placebo (P < .05 for BZA 20 mg/CE 0.625 mg and P < .01 for BZA 20 mg/CE 0.45 mg).

"The most exciting thing about this study is that it will help women to go ahead and seek treatment, said Ms. Yu. "[Patients] have been concerned about the side effects of various products, but this one will help them with overall menopausal symptoms, including reducing nighttime awakenings, which will certainly lead to better overall sleep."

Funding for this trial was provided by Wyeth Pharmaceuticals, Inc.

[Presentation tile: Effects of Bazedoxifene/Conjugated Estrogens on Sleep and Overall Menopause Symptoms. Abstract 65]

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