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Epilepsy Drug Emerges as HRT Alternative
Jan. 31, 2003 -- A drug traditionally used to treat epilepsy and migraine may be a valuable alternative to hormone replacement therapy (HRT) for postmenopausal women who suffer from hot flashes. A new study shows use of the drug, known generically as gabapentin and sold under the name Neurontin, can reduce both the frequency and severity of hot flashes.
Researchers say hot flashes affect about 75% of postmenopausal women, and women who suffer from hot flashes are also more likely to suffer from sleep and mood disturbances than others. Hormone replacement therapy is one of the few effective treatments for treating these symptoms of menopause, but many women are now looking for alternative treatments in the wake of recent research that has shown HRT can slightly increase the risk of heart disease and breast cancer in some women.
The study, published in the February issue of Obstetrics and Gynecology, compares the effects of gabapentin vs. a placebo in relieving hot flashes.
Researchers randomly assigned a group of 59 postmenopausal women who suffered from seven or more hot flashes a day to receive either the drug or a placebo for 12 weeks. During that period, the women kept a diary to record their hot flash frequency and severity.
The study found that women who took a low dose of the drug (900 mg/day) reported a 54% reduction in overall hot flash activity (both frequency and severity) compared with a 31% drop in the placebo group.
After the study ended, the women were also given the opportunity to participate in a five-week extended trial in which they took higher doses of the drug (up to 2,700 mg/day). Researchers found these higher doses were associated with an even higher reduction (up to 67%) in hot flash activity.
"It's very exciting to have an effective, non-hormonal hot flash treatment for women who have chosen to discontinue their hormone replacement therapy," says researcher Thomas L. Guttuso Jr., MD, a neurologist at the University of Rochester Medical Center, in a news release.
Gabapentin is FDA-approved for the treatment of epilepsy and shingles pain, but it is also frequently used to treat migraine headache, panic disorder, and social phobia. Side effects of the drug include sleepiness, dizziness, and leg swelling. About 13% of the women in the study dropped out because of side effects.
Guttuso says women should slowly increase their dose of the drug and take it with food to minimize potential side effects.
Researchers say more studies are needed to understand how gabapentin relieves hot flashes, but Guttuso says the drug may interact with calcium channels in the brain to create a reduction in the release of a chemical in the brain associated with hot flashes.
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VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.
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