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Venlafaxine and estradiol alleviate hot flushes and night sweats

Venlafaxine and low-dose estradiol alleviate menopause-related hot flushes and night sweats, according to the results of a placebo-controlled clinical trial published in JAMA Internal Medicine (26 May 2014).

The study provides “robust evidence” of the efficacy and tolerability of low-dose oral 17ß-estradiol and the nonhormonal serotonin-noradrenaline reuptake inhibitor (SNRI) venlafaxine, say the researchers.

In the UK, no serotonergic drug is currently licensed for the menopause, says Chloe Benn, principal pharmacist for women’s and children’s services at Royal Free London NHS Foundation Trust. The use of these types of agents, especially the SNRIs, are limited by a high incidence of nausea, adverse sexual effects and discontinuation symptoms.

The researchers randomly assigned 339 perimenopausal and postmenopausal women to one of three treatments: oral 17ß-estradiol 0.5mg/day, venlafaxine extended release 75mg/day or placebo for eight weeks. After unblinding the study cohorts, women in the estradiol group received medroxyprogesterone acetate for 14 days for endometrial protection.

The primary end point was the mean daily frequency of vasomotor symptoms (hot flushes and night sweats), which at the end of treatment fell by 52.9% to 3.9 symptoms per day in the estradiol group, by 47.6%, to 4.4 per day in the venlafaxine group and by 28.6% to 5.5 per day in the placebo group.

Both drugs were more effective than placebo for the primary endpoint and for secondary measures of symptom severity, bother and interference, and both were well tolerated. However, patient-reported treatment satisfaction was highest for estradiol, at 70.3%, and 51.5% for venlafaxine and 38.4% for placebo.

“Treatment decisions should weigh the risk profile of each agent for each individual woman, taking into account her risk factor status and personal preferences regarding treatment options,” the investigators conclude.

Nuttan Tanna, consultant pharmacist in women’s services for North West London NHS Trust, welcomes the study’s findings but says the estradiol dose used in the trial is unusual in clinical practice most women receive 1mg/day.

“The use of 0.5mg is interesting,” she says. “The research team therefore ‘in principle’ left women with intact uteri on unopposed estrogen, but put these women on progestin after unblinding at eight weeks. In clinical practice we need information on use of HRT (estrogen and progestin as combined therapy) versus venlafaxine.”

The National Institute for Health and Care Excellence currently recommends paroxetine, fluoxetine, citalopram or venlafaxine where HRT is contraindicated or not preferred. “There are other nonhormonal alternative treatments for vasomotor symptoms, including clonidine and gabapentin,” says Benn.

Citation: The Pharmaceutical Journal URI: 11139010

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