Bone-Enhancing Raloxifene Doesn't Increase "Hot Flashes"

Alternative To HRT For Bone Strength Studied

For women looking to stop hormone replacement therapy and switch instead to the bone-enhancing drug Raloxifene, there is good news: You will not experience any increase in hot flashes.

Raloxifene is known as a SERM, a selective estrogen reuptake modulator. These are the so-called "designer" estrogens - medications that act like a hormone in certain areas of the body, such as the bones, while acting as an "anti-hormone" in other areas, such as the breasts and uterus.

In this way, a SERM can offer some of the same health benefits as estrogen with fewer risks, says Dr. Steven Goldstein, a professor of obstetrics and gynecology at New York University School of Medicine.

The finding, published in the medical journal Obstetrics and Gynecology, is also the first to document that once discontinuing hormone replacement therapy (HRT), the peak recurrence of hot flashes can be expected at approximately eight weeks, rather than four.

"This study is important because drugs similar to Raloxifene have been shown to increase hot flashes and, in fact, at least one never came to market because of this problem," says Dr. Goldstein.

One of the downsides of SERMS has been a tendency to increase hot flashes. This can be a problem for women wanting to get off HRT and take this alternative approach to bone health.

"What this study told us is that you can stop taking HRT on a Sunday and start taking Raloxifene on a Monday and it won't cause you to have any more hot flashes than you might otherwise have when stopping HRT," Dr. Goldstein says.

Hot Flashes a Fact of Life for Many Women

It is important to note, however, that most women who do stop HRT experience a return of at least some hot flash activity. All the new study is saying is the introduction of Raloxifene into the regimen will not exacerbate the problem, Dr. Goldstein adds.

Health experts say the second finding - that hot flashes peak at about eight weeks rather than four after stopping HRT - is also important.

The study authors suggest the commonly used "washout" period at four weeks - when HRT doses are slowly tapered off - may not be relevant because symptoms will not peak until eight weeks.

Dr. Goldstein believes, however, that if the tapering is gradual enough and the dosages of HRT carefully monitored, the incidence of hot flashes can be controlled.

The study involved 266 women who had been taking HRT for at least five months. Each woman was assigned to take one of the following treatments for 12 weeks: HRT; a placebo (an inactive substance); HRT for four weeks, followed by Raloxifene for eight weeks; or Raloxifene alone.

This initial treatment was followed by 36 weeks of Raloxifene-only therapy for all the women.

The result: Raloxifene did not appear to increase the risk of hot flashes over and above a placebo, when used after discontinuation of HRT.

Second Study Rules Out Urinary Incontinence

In another study of Raloxifene, also published in Obstetrics and Gynecology, a different group of physicians found the drug did not increase the risk of urinary incontinence, even after three years of treatment.

This research involved nearly 1,000 women at 10 sites across the US. All of them were at least two years past menopause and diagnosed with osteoporosis.

Each of the women filled out a questionnaire at the start of the study detailing, among other things, any incidence of incontinence. They were then assigned to take either a placebo or Raloxifene for three years. At the conclusion they were once again questioned on the same topics.

The result: The use of Raloxifene did not worsen any incontinence problems already present. And it did not bring on the condition in those who did not experience it before.

Eli Lilly and Co., the maker of Raloxifene, supported the two studies reported. 

Always consult your physician for a diagnosis.

Talking With Your Healthcare Provider 

The National Women's Health Information Center provides the following tips on questions to ask:

Make a list of concerns and questions to take to your visit with your healthcare provider. While you're waiting to be seen, use the time to review your list and organize your thoughts.

Describe your symptoms clearly and briefly. Say when they started, how they make you feel, what triggers them, and what you have done to relieve them.

Tell your healthcare provider what prescription and over-the-counter medicines, vitamins, herbal products, and other supplements you're taking. Be honest about your diet, physical activity, smoking, alcohol or drug use, and sexual history - withholding information can be harmful. Describe allergies to drugs, foods, or other things. Do not forget to mention if you are being treated by other healthcare providers.

Do not feel embarrassed about discussing sensitive topics. Do not leave something out because you are worried about taking up too much time. Be sure to have all of your concerns addressed before you leave.

If tests are ordered, be sure to ask how to find out about results and how long it takes to get them. Get instructions for what you need to do to get ready for the test(s) and find out about any risks or side effects with the test(s).

When you are given medication and other treatments, ask your healthcare provider about them. Talk about the latest studies and recommendations for treating menopausal symptoms. Ask how long treatment will last, if it has any side effects, how much it will cost, and if it is covered by insurance. Make sure you understand how to take your medications; what to do if you miss a dose; if there are any foods, drugs, or activities you should avoid when taking the medicine; and if there is a generic brand available at a lower price (you can also ask your pharmacist about this).

Understand everything before you leave your visit. If you do not understand something, ask to have it explained again.

Bring a family member or trusted friend with you to your visit. That person can take notes, offer moral support, and help you remember what was discussed. You can also have that person ask questions as well.

Online Resources

(Our Organization is not responsible for the content of Internet sites.)    

American College of Obstetricians and Gynecologists

Centers for Disease Control and Prevention (CDC)

HealthierUS.Gov

National Institutes of Health (NIH)

National Women's Health Information Center

Office of Research on Women's Health

March 2004

Bone-Enhancing Raloxifene Does Not Increase "Hot Flashes"

Hot Flashes a Fact of Life for Many Women

Second Study Rules Out Urinary Incontinence

Talking With Your Healthcare Provider

Menopause Defined

Online Resources

Menopause Defined

When a woman permanently stops having menstrual periods, she has reached the stage of life called menopause.

Often called the "change of life," this stage signals the end of a woman's ability to have children.

Many physicians actually use the term menopause to refer to the period of time when a woman's hormone levels begin to change. Menopause is said to be complete when menstrual periods have ceased for one continuous year.

The transition phase before menopause is medically referred to as climacteric, but more recently has also been called perimenopause.

During this transition time before menopause, the supply of mature eggs in a woman's ovaries diminishes and ovulation becomes irregular.

At the same time, the production of estrogen and progesterone decreases. It is the enormous drop in estrogen levels that causes most of the symptoms commonly associated with menopause.

While the average age of menopause is 51, menopause can actually occur any time between the ages of 40 and 55. Women who smoke and are underweight tend to experience an earlier menopause, while women who are overweight often experience a later menopause. Generally, a woman tends to experience menopause at about the same age as her mother did.

Menopause can also occur for reasons other than natural reasons. These include, but are not limited to, the following:

• premature menopause
  Premature menopause may occur when there is ovarian failure before the age of 40, and may be associated with smoking, radiation exposure, chemotherapeutic drugs, or surgery that impairs the ovarian blood supply.

• surgical menopause
  Surgical menopause may follow an oophorectomy (removal of an ovary or both ovaries), or radiation of the pelvis, including the ovaries, in premenopausal women. This results in an abrupt menopause, with women often experiencing more severe menopausal symptoms than if they were to experience menopause naturally.

Each woman may experience symptoms differently - with some having few and less severe symptoms, while others have more frequent and stressful ones.

Hot flashes are, by far, the most common symptom of menopause, with about 75 percent of all women experiencing sudden, brief, periodic increases in their body temperature.

Usually hot flashes start before a woman's last period. For 80 percent of women, hot flashes occur for two years or less.

A small percentage of women experience hot flashes for more than two years. These flashes seem to be directly related to decreasing levels of estrogen.

Hot flashes vary in frequency and intensity for each woman.
In addition to the increase in the temperature of the skin, a hot flash may cause an increase in a woman's heart rate.

This causes sudden perspiration as the body tries to reduce its temperature. This symptom may also be accompanied by heart palpitations and dizziness.

Hot flashes that occur at night are called night sweats. A woman may wake up drenched in sweat and have to change her night clothes and sheets.
 
Vaginal atrophy involves the drying and thinning of the tissues of the vagina and urethra.

This can lead to dyspareunia (pain during sexual intercourse), as well as vaginitis, cystitis, and urinary tract infections. 

Relaxation of the pelvic muscles can lead to urinary incontinence and also increase the risk of the uterus, bladder, urethra, or rectum protruding into the vagina.

Intermittent dizziness, paresthesias (an abnormal sensation such as numbness, prickling, tingling, and/or heightened sensitivity), cardiac palpitations, and tachycardia may occur as symptoms of menopause.

Changing hormones can cause some women to experience an increase in facial hair and/or a thinning of the hair on the scalp.

While it is commonly thought that mental health may be negatively affected by menopause, several studies have indicated that menopausal women suffer no more anxiety, depression, anger, nervousness, or feelings of stress than women of the same age who are still menstruating.

Psychological and emotional symptoms of fatigue, irritability, insomnia, and nervousness may be related to both the lack of estrogen, the stress of aging, and a woman's changing roles.

Always consult your physician for more information.