A New Non-Estrogen for Hot Flashes
I recently interviewed presenters at the annual meeting of the North American Menopause Society (NAMS) in Orlando, Florida.
One new study to keep an eye on evaluated the effectiveness of a modified version of an antidepressant drug – paroxetine. The study was designed as part of the FDA approval process to evaluate a low-dose variant of an existing medication sometimes used for hot flashes. The hope was that this modified lower dose version would be an effective non-estrogen treatment for hot flashes with fewer side effects than the existing paroxetine.
The new drug differs from the original one in that it has a slightly different chemical structure that allows it to be used in a lower dosage. It is technically called a low-dose mesylate salt of paroxetine or LDMP. The intent was to prevent the frequently found side effects of the full dosage for which nausea, weight gain, and reduced sexual function are common.
The study evaluated LDMP in approximately 500 women who had at least seven hot flashes daily and were very affected by their symptoms. Half of the women received LDMP and the other half received a placebo. The women were followed for 12 weeks for efficacy and for a total of 24 weeks for safety.
Paroxetine comes in dosages of 10mg, 20mg, 30mg and 40mg. In this study, a low-dose of 7.5 mg of the mesylate salt of paroxetine was able to statistically reduce hot flashes both in frequency and severity compared to women who received a placebo.
The effect began at one week and became statistically significant shortly after that. The benefits remained statistically significant at 4, 8, 12, and 24 weeks, which was the duration of the study.
There was a low frequency of side effects; most commonly nausea, that occurred in 4 percent of treatment group compared to 1 percent of placebo.
Hot flashes affect approximately 75 percent of women as they enter and pass through perimenopause and menopause. As millions of women know, hot flashes are very disruptive and affect the way they feel and sleep and the quality of their lives.
So naturally, women in menopause are looking for a safe and effective treatment for hot flashes. For now, the one approved and effective treatment is estrogen. Unfortunately, estrogen, also called estrogen therapy (ET), hormone therapy (HT) or in the past, hormone replacement therapy (HRT) comes with side effects and risks that make it an unacceptable or undesirable choice for many women.
LDMP is currently being evaluated at the FDA and hopefully will become an FDA approved non-hormonal alternative to treat hot flashes some time near the end of 2013. See my interview above with the lead investigator, Dr. Jim Simon.
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