In this first of a three-part interview, we discuss the latest research that may help women dealing with moderate to severe hot flashes. The author of this sub-study, Dr. JoAnn V. Pinkerton, Medical Director of the Midlife Health Center and Professor of Obstetrics and Gynecology, University of Virginia, takes a whole-care health approach with her patients during and beyond menopause.
Dr. Pinkerton offers further insight into this research study, what the initial results mean for women, and how these findings about PRISTIQ play a part in the evolving attitudes towards menopause and women’s overall health.
Q: To clarify, what were the ages of the 365 PRISTIQ trial participants and what made them suitable candidates for this study? Was there any particular emphasis on women in early or late stages of menopause or were the symptoms the most important consideration?
Dr. JP: “These women ranged in age from 45-71 with the average age being 52. These women were selected based on having moderate to severe hot flashes or being very symptomatic and needing treatment because their lives were significantly impacted as a consequence. We are talking about women dealing with at least seven or more hot flashes per day or around 50 per week, and whose hot flashes interfered with completing daily tasks, getting sufficient sleep, and contributing to an overall poor quality of health.”
Q: Compared to current HRT treatment options for vasomotor symptoms, will PRISTIQ be more suitable for a larger segment of the population and help to fill any existing gaps?
Dr. JP: “Our goal is that PRISTIQ will provide an alternative to hormone replacement therapy for those who cannot or choose not to take HRT.
For those symptomatic women who are candidates for estrogen, the good news is that in 2007, the Women’s Health Initiative (WHI) investigated and updated their original statement on HRT from July of 2002.
This reanalysis showed that women under age 60, or those within ten years of menopause, who took estrogen or other HRT for their menopause symptoms found the majority of the health risks on HRT occurred in the population beyond 60. Moreover, mortality was decreased for those under 60 on HRT compared to the general population.
This means that HRT is a reasonable option for symptomatic women under age 60 as they will not face increased mortality rates. The preferred FDA approved type of treatment still applies to those acutely symptomatic women who do not have any reasons for not taking or do not fear taking HRT. Physicians advocate using lower dose prescriptions for a three to five year range or as required to manage symptoms.
Similar recent studies, still in the testing stages, indicate a combination of estrogen and anti-estrogen for women who cannot or choose not to take estrogen. We need to have FDA approved options to offer symptomatic women, but currently only estrogen is FDA approved. Other mediations appear to improve hot flashes, but they are not FDA approved to treat hot flashes. As a result, doctors may resort to off-label suggestions. (Editor’s note: off-label refers to a medication used for other than its intended or listed purposes.)
If FDA approval is granted for PRISTIQ, doctors will have a non-hormonal option for women. This is important because we are pleased with the success rates from the study; PRISTIQ worked 63% or the time for highly symptomatic women vs. 38% of the time for those taking a placebo.
This statistical and clinical difference shows a decrease in the number and severity of hot flashes. Even more importantly, the effects were fairly rapid, with a median 50% reduction in the number of hot flashes in as little as 13 days (compared to 28 days with placebo); indicating PRISTIQ works better and faster than placebo.
In the studies, women are getting the results that make a difference. This is a group of women having up to 11 or even more hot flashes ever day. Women who have severe menopause symptoms such as these find that they are very disruptive, affecting everything from work to sleep. There is a huge clinical improvement; the possibility of providing a medication that improves women’s work and home lives.”
Q: Hot flashes are not life threatening but they are annoying and one of the most common complaints during menopause. Besides the hot flashes themselves, why is it important to allocate research and resources to vasomotor symptoms studies? Is this research based on women’s quality of life, or are there any additional aims regarding women’s health?
Dr. JP: “When we are looking at hot flashes or night sweats, we also need to look further into their impact on quality of life. Treatment of hot flashes with non-HRT does provide improvement in other areas of women’s health such as heart disease, osteoporosis, or libido issues. We need to be concerned about cholesterol levels, bone health, and genital dryness to understand the whole health picture for these women.
Therefore, hot flash research encourages research into all aspects of women’s health. Hot flashes are just one piece of the puzzle but in this particular sub-study, we met the goals of the study in terms of effectiveness, rapidity of effect, and overall tolerance. All of this shows promise for continuing allocating the necessary resources into women’s healthcare research.
Our interview continues by discussing patients currently taking PRISTIQ for depression. Plus Dr. Pinkerton advises how women can sort through the abundance of information with their doctor’s help.
A very special thank you to Dr. Joann V. Pinkerton for our recent telephone interview May 13, 2011.
Menopause, Your Doctor, and You