Is Desvenlafaxine Effective for Reducing Hot Flashes In Postmenopausal Females

OBJECTIVE: The objective of this selective Evidence Based Medicine (EBM) review is to determine whether or not Desvenlafaxine is effective in reducing daily hot flashes in postmenopausal females. STUDY DESIGN: Review of three primary randomized controlled trials (RCTs) published after the year 2000 in the English language. DATA SOURCES: Three double-blind, randomized controlled trials were found using PubMed and EBSCOhost Web. All trials selected compared treatment with Desvenlafaxine to a visually matched placebo. OUTCOMES MEASURED: Patients completed daily diary cards on which they recorded the number and severity of daily hot flashes from the screening period through the 12 weeks of therapy. Patients completed self-administered questionnaires at baseline and after 12 weeks of treatment: Profile of Mood States, Work Limitations, Menopause Symptoms Treatment Satisfaction, Sexual Functioning, EuroQuality of Life Visual Analog Scale, Greene Climacteric Scale (GCS). RESULTS: All three RCTs demonstrated a statistically significant reduction in the number of moderate to severe daily hot flashes in postmenopausal women receiving treatment with Desvenlafaxine compared to those receiving the placebo. CONCLUSION: The results of the RCTs evaluated suggest Desvenlafaxine is effective in reducing the daily number of moderate-severe hot flashes in postmenopausal women. KEY WORDS: Desvenlafaxine, hot flashes, vasomotor symptoms, menopause, serotoninnorepinephrine reuptake inhibitor Graziano, Desvenlafaxine and Hot Flashes 1 INTRODUCTION Vasomotor symptoms, more commonly known as hot flashes, are transient periods of extreme warmth, flushing and sweating, most commonly affecting the trunk and face. Subsequent chills, anxiety and heart palpitations often occur concomitantly with hot flashes. Hot flashes ordinarily begin during the transition to menopause, and according to several trajectory studies, are most bothersome during late perimenopause and early postmenopause. Hot flashes are the most commonly reported menopausal symptom and affect as many as 79% of postmenopausal females in the United States. Vasomotor symptoms are such a prevalent problem for women, and result in increased direct and indirect costs as well as increased healthcare utilization. In a study of more than 500,000 women, it was calculated that women with hot flashes incurred an additional $339,559,598 in direct health care costs per year and $27,668,410 in indirect costs. Women affected by hot flashes in the study population had 1.5 million office visits over the one year period, representing an 82% increase in general outpatient visits, and a 121% increase in visits specifically for hot flashes as compared to control counterparts. The mechanism of hot flashes is multifaceted and not entirely understood, but it is likely related to declining estrogen production from the ovaries during menopause. More noticeable oscillations in core body temperature result from a restricted thermoneutral zone in females undergoing the menopausal transition. Vasodilation and increased blood flow to the trunk and face are responsible for the initial flushing feeling that is often followed by profuse sweating. Palpitations, anxiety, night sweats and consequent insomnia frequently accompany hot flashes. There are several therapies currently available to treat vasomotor symptoms associated with menopause. For quite some time, the mainstay of treatment was hormone replacement Graziano, Desvenlafaxine and Hot Flashes 2 therapy, consisting of estrogen, progestogen or a combination of the two. Nonhormonal pharmacological therapies include selective serotonin reuptake inhibitors (SSRIs), serotoninnorepinephrine reuptake inhibitors (SNRIs), Clonidine, and Gabapentin. An emphasis is also placed on nonpharmacologic therapies including behavioral changes, such as dressing in layers, setting a low room temperature and avoiding spicy foods and alcohol. Complementary and alternative treatments such as Black Cohosh, acupuncture and hypnosis are additionally being studied for the reduction of vasomotor symptoms. 3 While hormone therapy remains the most effective method for treating hot flashes, the use of hormone therapy has significantly declined after results were released from the 2002 Women’s Health Initiative (WHI). 4 The WHI highlighted several major risks associated with hormone therapy including breast cancer, pulmonary embolism, stroke and coronary heart disease, causing many to question whether the benefits outweighed the risks. Treatment with Desvenlafaxine, a serotonin norepinephrine reuptake inhibitor (SNRI), is being proposed because Desvenlafaxine has been shown to be an effective nonhormonal treatment alternative for hot flashes. This review evaluates three double-blind, randomized, placebo-controlled trials comparing the efficacy of Desvenlafaxine, a SNRI, as an oral nonhormonal medication for reducing hot flashes in postmenopausal females.