June 4, 2014
Venlafaxine Nearly Equal To Estrogen in Reducing
Boston—Can a nonhormonal therapy be as effective as oral estrogen in reducing the number of hot flashes and night sweats plaguing menopausal women?
A new study from Brigham and Women's Hospital (BWH) suggests that it can come close. The research, published recently in JAMA Internal Medicine, compared both low-dose oral estrogen and low-dose venlafaxine hydrochloride extended release to placebo and found both were effective in reducing vasomotor symptoms (VMS) reported by menopausal women.
The authors note that their study is the first to simultaneously evaluate estrogen therapy compared to venlafaxine, a first-line treatment in women who are unwilling or unable to use ET. Venlafaxine hydrochloride extended release is marketed as Effexor XR.
“Estrogen therapy (ET) is the gold standard treatment for hot flashes and night sweats, but some women are unable or unwilling to use it because of associated risks,” according to background in the article. “The serotonin-norepinephrine reuptake inhibitor venlafaxine hydrochloride is used widely as a non-hormonal treatment. While the clinical impression is that serotonin-norepinephrine reuptake inhibitors are less effective than estrogen, these medications have not been simultaneously evaluated in one clinical trial to date.”
“Since the publication of the Women's Health Initiative findings, which demonstrated risks associated with ET and led to our current recommendations—that ET be used only at the lowest possible dosage for the shortest possible duration—there has been increased interest in non-hormonal treatments,” added lead author Hadine Joffe, MD, MSc, director of the Women’s Hormone and Aging Research Program at BWH. “Our new findings provide critical data for physicians and women making treatment decisions for hot flashes/night sweats. Our data show that first-line hormonal and non-hormonal pharmacological treatments are well-tolerated and effective options for alleviating symptoms.”
Joffe pointed out that VMS symptoms such as hot flashes and night sweats affect up to 80% of women in midlife and are the primary symptoms leading menopausal women to seek medical attention.
Between December 5, 2011, and October 15, 2012, 339 perimenopausal and postmenopausal women with bothersome VMS were recruited for the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) trial. The objective of the National Institutes of Health–sponsored study was to determine the benefit and tolerability of low-dose estradiol and low-dose venlafaxine therapy to resolve hot flashes and night sweats.
For the study, researchers randomized participants to one of the treatments for 8 weeks. At the end of the study period, results indicate that the frequency of hot flashes/night sweats decreased by 52.9% with estradiol, 47.6% with venlafaxine, and by 28.6% with placebo.
The authors report that, on average, estradiol reduced the frequency of symptoms by 2.3 more per day and venlafaxine by 1.8 more per day than placebo, with the effect statistically significant for both therapies compared to placebo.
The difference in how much symptoms were reduced by low-dose estradiol compared to venlafaxine—0.6 more per day—was not statistically significant, however. While the benefit of low-dose estradiol was found to be slightly superior to venlafaxine in this study, the authors emphasize that the difference was found to be small and likely of limited clinical relevance.
Similar outcomes were found for secondary outcomes, such as hot flash/night sweat severity and the interference of symptoms with daily life.
Overall treatment satisfaction was highest for estradiol, intermediate for venlafaxine, and lowest for placebo, according to the report, although both interventions were well tolerated.
|U.S. Pharmacist Social Connect