WCO: Raloxifene Side Effects Less Bothersome Than Alendronate Or Hormone Replacements
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WCO: Raloxifene Side Effects Less Bothersome Than Alendronate Or Hormone Replacements

CHICAGO, IL -- June 19, 2000 -- Women are far more likely to continue using raloxifene hydrochloride (Evista, Eli Lilly and Company) for the prevention of osteoporosis than they are any other medications, including estrogen replacement therapy, it was reported at this year's meeting of the World Congress on Osteoporosis.

Previous studies have shown that 40 per cent of women will not even have their prescription for a common estrogen-based product filled a second time -- that is to say they take it for one or two months, and then stop. Women taking raloxifene, however, are 34 percent more likely to continue taking the drug for one year or more.

Dr. Bruce Ettinger, a professor of medicine at the University of California at San Francisco and senior investigator at the Kaiser Permanente medical care program in northern California, presented from what he said was the first truly objective study to examine women’s compliance with hormone replacements and SERMs (selective estrogen receptor modulators), of which raloxifene is one.

Compliance has long been an issue for women taking hormone replacement therapies, and to date, there has been little research as to why women stop taking the medications, despite knowing its benefits, he said.

The study he conducted involved 1003 women over the age of 60 who were taking hormone replacements, and 331 women who were taking raloxifene. It was found that 68 percent stopped taking the hormone within the first year, whereas only 48 per cent of women stopped taking raloxifene within the first year.

By comparison, in a similar study, just over 60 per cent of women who had been taking the bisphosphonate alendronate (Fosamax, Merck & Co) stopped taking the drug within the first year, citing new upper gastro-intestinal complaints in more than half of the cases. A further 26 percent of women were advised by their doctors to discontinue Fosamax within one year, Dr. Ettinger added. Only 25-30 per cent of women who started on alendronate were still taking it at the end of three years.

It's also interesting to note that in a study of more than 3,000 women who were taking nasal calcitonin to prevent osteoporosis, more than 60 per cent discontinued the drug within the first year.

Data from a further telephone survey of women who had been taking raloxifene and participated in the original survey were also interesting. The women had been taking raloxifene for a mean of 7.4 months when they took part in the telephone interviews. Among their reported comments, 45 per cent were taking raloxifene despite having a history of breast cancer.

"Clearly in the US and elsewhere, raloxifene is not indicated for the treatment or prevention of breast cancer but physicians are prescribing this drug for women who are at high risk, or who have had breast cancer in the past," he said.

A further 24 per cent of women who were taking it reported a history of osteoporosis, or osteopenia.

"There were significant differences in ages as to who would continue taking hormone replacements and who would stop, with women over the age of 65 being much more likely to stop, complaining of breast tenderness and renewed bleeding," he said.

Side effects from raloxifene, particularly hot flashes, are a significant issue, and yet in this study, only 20 per cent of women said they were bothered by hot flashes, and only two per cent said the hot flashes were severe enough that they stopped taking the drug as a result.

"It's interesting that among these women, very few of them had any other side effects, in other words, it was quite tolerable from that point of view," he said. Women with osteoporosis, or who are at risk of osteoporosis need more than just a quick fix and therefore it is important that physicians prescribe a drug that the woman is most likely to continue taking, he said.

Related Links: raloxifene (Evista), Eli Lilly and Company, alendronate (Fosamax) and Merck & Co.

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