Treating Menopause: Are We Going Loco?

Charles P. Vega, MD


August 06, 2013

In This Article

Nonhormonal Agent for Vasomotor Symptoms of Menopause

While physicians need to be careful about embracing hormone therapy too closely, the recent FDA approval of a new formulation of paroxetine (Brisdelle™) reflects ongoing paranoia about the dangers of hormone treatment. This is the first nonhormonal agent approved for vasomotor symptoms of menopause. Clinical data support the use of paroxetine in the management of these symptoms. In one placebo-controlled trial of 165 women, controlled-release paroxetine resulted in reductions of hot flash composite scores of over 60%.[9] The results were similar in a study of paroxetine 10 and 20 mg, with some evidence of patient intolerance of the higher dose.[10]

This new formulation, a low-dose mesylate salt of paroxetine (LDMP), addresses the tolerability issue and allows for a dose of only 7.5 mg daily, well below the dose of paroxetine typically used to treat depression. In a randomized trial of 568 women, participants taking LDMP experienced an average of 9 fewer hot flashes per week compared with women receiving placebo.[11] After 24 weeks of therapy, relief from hot flashes was reported by 47.5% of women treated with LDMP and by 36.3% of participants receiving placebo. Adverse events were generally similar in comparing LDMP and placebo.

Physicians should also bear in mind that venlafaxine and gabapentin have been demonstrated to be effective in the treatment of hot flashes, although these agents do not have FDA approval for this indication.[12] It is important to have nonhormonal options for the treatment of hot flashes among women at risk for complications of hormone therapy, including those with a history of cancer or who are at elevated risk for venous thrombosis.

But physicians should focus their use of nonhormonal treatment for hot flashes based on risk factors, not efficacy. There are no trials comparing hormone therapy vs nonhormone therapy, but it is understood that hormone therapy has remained highly effective for vasomotor symptoms for many years. Offering nonhormonal therapy to a broad population of women will not only expose them to a new array of side effects, but it may also be less effective than using hormone therapy. If the makers of LDMP are confident in their product, then a trial of women in early menopause treated with LDMP, hormone therapy, or placebo is in order. Until then, hormone therapy should remain first-line treatment for vasomotor symptoms for the majority of menopausal women.

It's like Mr. Martin told us in 1999:

She's into new sensations
New kicks in the candle light
She's got a new addiction
For every day and night
(lyrics from "Livin' La Vida Loca" by Ricky Martin)

Sometimes the cure for la vida loca, like hot flashes, is employing what is tried and true.


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