Mayo Clinic Researchers Say Agent Provides Treatment Option for Women with H...(treat diabetic peripheral neuropathy and...),Health

Date:5/18/2009

treat diabetic peripheral neuropathy and for shingles; anecdotal evidence suggested that menopausal women who used it had a reduction in hot flashes, Dr. Loprinzi says. Multiple placebo-controlled studies have since demonstrated that this drug decreases hot flashes.

Gabapentin and a variety of antidepressants are now commonly prescribed for treatment of hot flashes, although these agents are not specifically approved by the FDA for such use.

Pregabalin is a newer version of gabapentin. "We thought it might also relieve hot flashes and thus was worth testing," Dr. Loprinzi says.

So, using funds from the National Cancer Institute, Dr. Loprinzi and colleagues set up a 207-participant study conducted by the North Central Cancer Treatment Group (NCCTG). The study was a Phase III double-blinded, placebo-controlled randomized trial, testing three different treatment arms: a placebo versus daily doses of 150 milligrams (mg) of pregabalin (75 mg twice a day) and 300 milligrams (150 mg twice a day). Patients getting pregabalin started off with lower doses which were increased weekly to the eventual full dose.

Participants, who reported having at least 28 hot flashes a week, kept a "hot flash diary" in which they recorded the number and severity of hot flashes they had each day while taking their study drug -- the content of which was unknown to them.

In the study group, 34 percent were using anti-estrogen therapy -- either an aromatase inhibitor, raloxifene, or tamoxifen -- to help prevent the recurrence of estrogen-sensitive breast cancer.

The researchers found that for the 163 patients for whom information was available, both doses of pregabalin reduced hot flashes to about the same degree, but that toxicities, such as cognitive dysfunction, were increased at the higher dose. Other reported side effects included weight gain, sleepiness, dizziness, coordination troubles, c
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