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New drug cleared for osteoporosis in women.

The FDA has cleared for marketing a new drug for the prevention of osteoporosis in postmenopausal women. Called Evista, the drug is the first in a class of new drugs called selective estrogen receptor modulators (SERMs) to be used for this purpose.

"Millions of postmenopausal women at risk for osteoporosis will soon have a new option for stopping bone loss and preserving their strength," says Dr. August M. Watanabe, president of Lilly Research Laboratories, a division of Eli Lilly and Company, the drug's manufacturer. Lilly expects the drug to be available in pharmacies by now.

Osteoporosis, which affects more than 28 million Americans, most of them women, is just one result of menopause. As a woman's ovaries stop producing estrogen, her bones become increasingly fragile and can easily break. Already more than 12,000 women in 28 countries have participated in 50 clinical studies on Evista.

"Clinical studies show that Evista acts like estrogen in the skeletal system and stops the loss of bone that occurs after menopause," says investigator Robert Lindsay, M.D., Ph.D., chief of internal medicine at Helen Hayes Hospital in New York. "The preservation of healthy bone is critical in preventing the onset of osteoporosis and protecting a woman during her postmenopausal years."

Evista was not shown in clinical trials to increase the risk of endometrial or breast cancer. However, as with most drugs, Evista is associated with some side effects, the majority of which were reported as mild. The most serious side effect associated with Evista was an increase in venous thromboembolic events, but this was rare. The most common side effect observed was a higher rate of "hot flashes" among women who took the drug during clinical studies, compared to those who took a placebo. Women taking Evista also reported a higher rate of leg cramps than women taking placebos; nevertheless, the cramps did not cause them to stop taking Evista.

The occurrence of adverse uterine tissue effects and vaginal bleeding were no different between women taking Evista and women taking placebos in clinical trials. In contrast, women taking hormone-replacement therapy (HRT) had an increased incidence of spotting and bleeding. Women taking Evista also reported no differences regarding breast pain between themselves and those who took placebos, but women taking HRT reported increased incidence of breast pain. Finally, Evista produced significant reductions in LDL (low-density lipoprotein, or "bad") cholesterol and total cholesterol, and did not change triglyceride levels.

Evista, under the generic name of raloxifene hydrochloride, will be available as a preventive for postmenopausal American women in 60 mg tablets. Its manufacturer has already submitted applications, to market the drug in more than 30 countries around the world.
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Author:Gramling, Jack
Publication:Medical Update
Date:Feb 1, 1998
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