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Hormone-Free Hot Flash Drug on Horizon

But Experimental Drug Pristiq Gets Mixed Reviews

Mixed Results continued...

In a 12-month study of the drug, women who had 50 or more moderate to severe hot flashes weekly were assigned to placebo or Pristiq (50, 100, 150, or 200 milligrams), says Margery Gass, MD, professor of obstetrics and gynecology at the University of Cincinnati and an author of the study. She found a 60% to 64% reduction in the hot flashes as well as fewer nighttime awakenings due to night sweats. "Overall, the 100-milligram dose worked best," she tells WebMD.

But in another study of 465 women, conducted by James Pickar, MD, of Wyeth, Pristiq did not work much better than placebo and was inferior to tibolone, a hot-flash-relieving drug not available in the U.S. At week 12, placebo reduced hot flashes by 57.5%, Pristiq by 57.7%, and tibolone by 81%.

Night sweats, awakenings, mood. In another study of 843 women, led by Archer, Pristiq increased the minutes slept without waking up from 29 on placebo to 42 on 100 milligrams of Pristiq and 40 minutes on 150 milligrams of Pristiq. Women on Pristiq reported better moods than those on placebo and had fewer awakenings during the night.

Sexual problems. Gass also asked the 689 women in her study to complete a questionnaire about any sexual problems. Of the 467 women who did, there were no differences in sexual problems among groups, whether on placebo or the various Pristiq doses. But among the entire group of 689, a higher number of those on Pristiq (4.2%) reported sexual problems such as decrease in desire compared with those on placebo (1.3%). This difference, however, was not significant, she says.

Caveats

"I think these are preliminary studies," says William Parker, MD, staff gynecologist at Santa Monica-UCLA and Orthopaedic Hospital in Santa Monica, Calif. "I'd like to see a head-to-head comparison study with SSRIs." Many doctors prescribe the SSRI antidepressants to help relieve hot flashes and other symptoms of menopause.

Parker points out, too, that nausea is one of the side effects reported with Pristiq use. Researchers say the nausea subsides. According to Wyeth spokeswoman Danielle Halstrom, a new technique of increasing the dose over three days is expected to remedy the nausea problem.

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