No weight gain or sexual dysfunction with first nonhormonal treatment for hot flashes

“Since the 2002 publication of initial findings of the [Women’s Health Initiative], women and clinicians have been much more interested in nonhormonal treatment options for moderate to severe vasomotor symptoms,” said Andrew M. Kauntiz, MD, at NAMS 2013.

“Because of this interest, we have seen extensive trials of SSRIs [selective serotonin reuptake inhibitors] and SNRIs [selective norepinephrin reuptake inhibitors] for the treatment of bothersome hot flashes. We recognize that these agents do have efficacy greater than placebo in the treatment of these distressing symptoms among menopausal women. However, a concern among women and their providers has been that SSRIs and SNRIs can cause unwanted weight gain as well as sexual side effects,” Dr. Kaunitz said.

Low-dose mesylate salt of paroxetine (Brisdelle), an SSRI, was FDA-approved in June 2013 as 7.5-mg paroxetine tablets—the first nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause.

Dr. Kaunitz and colleagues pooled the data from two Phase 3 randomized, double-blind, placebo-controlled trials that demonstrated reduced frequency and severity of vasomotor symptoms and favorable tolerability with the 7.5-mg paroxetine formulation.

They found no clinically meaningful or statistically significant changes from baseline in weight or sexual function among the paroxetine group (median weight 74.5 kg) versus placebo (75.8 kg). The median body mass index (BMI) was 27.9 kg/m ² among women using paroxetine versus 28.2 kg/m ² in the placebo group. The Arizona Sexual Experience Scale (ASEX) score was 59% in the paroxetine group versus 58% in the placebo group.

In addition, no significant difference between treatment groups was observed in the proportion of patients who had a gain in body weight of 7% or greater at weeks 4, 12, or 24. The rates of adverse events suggestive of sexual dysfunction were low and were similar in both treatment groups.

“What’s encouraging with our clinical trial findings is that it is the first nonhormonal treatment for menopausal vasomotor symptoms and does not cause weight gain or sexual side effects," said Dr. Kaunitz.

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