ORLANDO, Fla. — During an abstract session at the North American Menopause Society 23rd Annual Meeting, researchers reported on data from a phase 3 study of low-dose mesylate salt of paroxetine, providing evidence that the drug reduced the frequency of vasomotor symptoms associated with menopause after just 4 weeks of treatment.
James A. Simon, MD, CCD, NCMP, FACOG, of George Washington University School of Medicine, and colleagues found that low-dose mesylate salt of paroxetine (LDMP) 7.5 mg per day at bedtime for 24 weeks was a safe and effective treatment for vasomotor symptoms associated with menopause.
James A. Simon
“Vasomotor symptoms, which include hot flashes and night sweats, are the most bothersome symptoms associated with menopause. They affect up to 80% of US women experiencing menopause, and hormone therapy is currently the only approved treatment for moderate to severe vasomotor symptoms,” Simon said during a presentation. “Therefore, there is an unmet need that exists for safe, effective, non-hormonal therapeutic treatment options for women who seek treatment for vasomotor symptoms.”
Simon said paroxetine mesylate is an orally administered selective serotonin reuptake inhibitor with a chemical structure related to paroxetine hydrochloride, and lower doses of paroxetine vs. doses prescribed for psychiatric disorders (ie, those <20 mg per day) may be efficacious in treating moderate to severe vasomotor symptoms associated with menopause while having improved tolerability.
The 24-week, multicenter, double blind, randomized, placebo-controlled phase 3 study of LDMP in postmenopausal women aged at least 40 years with more than seven moderate-to-severe hot flashes daily included 570 patients (285 per group).
According to data, all 570 women were randomly assigned, and 453 completed the study (235 to LDMP; 218 to placebo).
Weekly reductions in vasomotor symptoms frequency were greater for those assigned to LDMP (–28.9) compared with placebo (–19) at week 4 (P<.0001). At week 12, the findings remained meaningful (–37.2% vs. –27.6%; P<.0001).
The mean weekly reductions in the severity of vasomotor symptoms also were significant for LDMP (–0.089) and placebo (–0.056) at week 4 (P=.0452). At week 12, the reductions were –0.123 for LDMP and –0.067 for placebo, also statistically significant (P=.0114).
By week 24, patients assigned to LDMP showed significantly more beneficial responses to therapy compared with placebo (47.5% vs. 36.3%).
Regarding treatment-emergent adverse events, Simon said the most common were nausea and bronchitis. However, these yielded no significant changes to laboratory values, vital signs or electrocardiograms in the LDMP or placebo group.
“There was a significantly greater reduction in the severity, as well as frequency, of moderate-to-severe hot flashes in weeks 4 and 12 with LDMP, compared with placebo. It was shown to be well tolerated and safe. These results provide support for LDMP at 7.5 mg per day at bedtime as a potentially safe and effective non-hormonal option for moderate-to-severe vasomotor symptoms associated with menopause,” Simon said. – by Samantha Costa
For more information:
Simon JA. S-2. Presented at: the North American Menopause Society 23rd Annual Meeting; Oct. 3-6, 2012; Orlando, Fla.
Disclosure: Simon is on the advisory board/review panel, has received grant or research support from, and/or has been on the speakers’ bureau for various entities, including: Abbott Laboratories, Agile Therapeutics, Amgen, Ascend Therapeutics, Azur Pharma, Bayer, BioSante Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Depomed, Endoceutics, Fabre-Kramer Pharmaceuticals, Laboratoire HRA Pharma, Meditrina Pharmaceuticals, Merck, Merrion Pharmaceuticals, NDA Partners LLC, Novartis Pharmaceuticals Corp., Novo Nordisk, Novogyne, Palatin Technologies, Pfizer, Shionogi, Slate Pharmaceuticals, Sprout Pharmaceuticals, Teva Women’s Health, Trovis Pharmaceuticals LLC, Warner Chilcott and Watson Pharmaceuticals.