article · Menopause The Journal of The North American Menopause Society
Two phase 3, multicentre, randomised, double-blind trials investigated the safety and efficacy of daily low-dose paroxetine 7.5 mg compared to placebo for treating menopausal vasomotor symptoms over 12 and 24 weeks. Across both studies, 591 postmenopausal women received paroxetine and 593 received placebo. The 24-week trial met all four primary efficacy endpoints, while the 12-week trial met three. Paroxetine significantly decreased weekly vasomotor symptom frequency compared to placebo at weeks 4 and 12 in both trials. Symptom severity was also significantly reduced at week 4 in the 12-week study, and at weeks 4 and 12 in the 24-week study. Therapeutic benefits persisted through 24 weeks. Adverse events were predominantly mild to moderate, without clinically significant changes in laboratory values or vital signs, and no withdrawal symptoms emerged following treatment cessation.
Vasomotor symptoms such as hot flushes cause substantial discomfort during menopause. These phase 3 clinical trial findings demonstrate that a low-dose 7.5 mg formulation of paroxetine provides a well-tolerated, non-hormonal treatment option that reduces both the frequency and severity of symptoms over several months without causing discontinuation issues.
This research evaluates a near-market pharmaceutical intervention, having completed phase 3 clinical trials in over 1,100 postmenopausal participants. The primary application is as a daily oral therapy for managing moderate to severe menopausal vasomotor symptoms. The evidence supports clinical adoption and regulatory pathways for pharmaceutical developers and healthcare providers seeking tested, non-hormonal prescription alternatives for postmenopausal women.
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OBJECTIVE: The efficacy and safety of low-dose paroxetine 7.5 mg for the treatment of menopausal vasomotor symptoms were evaluated in two multicenter, double-blind, placebo-controlled, phase 3 studies of 12 and 24 weeks' duration. METHODS: Postmenopausal women were randomly assigned 1:1 to receive paroxetine 7.5 mg or placebo once daily. The four primary efficacy endpoints included mean changes in the frequency and severity of moderate to severe vasomotor symptoms on weeks 4 and 12; an additional endpoint was persistence of treatment benefit on week 24. RESULTS: Five hundred ninety-one participants were randomly assigned to treatment with paroxetine 7.5 mg, and 593 participants were randomly assigned to treatment with placebo. All primary endpoints were met in the 24-week study; three of four primary endpoints were met in the 12-week study. In both studies, paroxetine 7.5 mg significantly reduced the mean weekly vasomotor symptom frequency compared with placebo on week 4 (P < 0.0001 for both studies) and week 12 (P = 0.0090, 12-wk study; P = 0.0001, 24-wk study). Mean weekly reduction in vasomotor symptom severity was significantly greater for paroxetine 7.5 mg than for placebo on week 4 (P = 0.0048) in the 12-week study and on week 4 (P = 0.0452) and week 12 (P = 0.0114) in the 24-week study. Persistence of treatment benefit was demonstrated in the 24-week study. Most treatment-emergent adverse events were mild or moderate in severity. No clinically significant changes in laboratory values or vital signs were noted, and no short-term discontinuation of symptoms followed treatment cessation. CONCLUSIONS: Paroxetine 7.5 mg is well-tolerated, is effective in reducing the frequency and severity of menopausal vasomotor symptoms, and demonstrates persistence of treatment benefit through 24 weeks of treatment.
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DOI: 10.1097/gme.0b013e3182a66aa7
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