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New Data on Raloxifene - Benefits come at a price - Breast Cancer Study Compares Drug to Tamoxifen

July 14th 2006

New Data on Raloxifene - Benefits come at a price - Breast Cancer Study Compares Drug to Tamoxifen

Tamoxifen and raloxifene

For the past several years, Lilly Pharmaceuticals and the National Cancer Institute have been conducting a head to head trial called STAR, comparing raloxifene (Evista) to Tamoxifen (Nolvadex) to see if one was better than the other at lowering the risk of breast cancer in high risk women.

As expected, both drugs yielded a strong benefit in lowering the risk of invasive breast in the women studied. Raloxifene appeared to be superior to tamoxifen because it provided equal protection against breast cancer while resulting in slightly fewer cases of endometrial cancer, serious blood clots, and cataracts; although, these differences were not large and may have been due to chance. Nevertheless, the results of this trial were sensationalized and made headlines.

 

Tamoxifen was shown long ago to lower the risk of getting breast cancer, but women were never really keen on using it for prevention since the side effects mentioned above really tipped the scale. Therefore, a need for a safer alternative became a priority. But just a few days ago, the results of another trial called RUTH, which was studying the effectiveness of raloxifene for heart disease prevention in at-risk women, were released and have lessened the hope that it will indeed become that much-sought-after alternative to Tamoxifen.

Raloxifene did not lower the risk of heart disease among the trial participants and it appeared to increase the risk of blood clots. Although the drug, unlike Tamoxifen or estrogen, did not raise the risk of stroke, the women who did have a stroke were slightly more likely to die from it if they were taking Raloxifene. These results were highly unexpected because previous clinical trials (MORE - Multiple Outcomes of Raloxifene) showed a heart disease benefit among the women who were at high risk.

 

The problem with MORE wasn't that the trial or its design were faulty and a complete fluke, it was that the researchers looked at the OVERALL heart disease outcomes first (part of the originial protocol), which were neutral but THEN went back and divided the women up according to their heart risk and found a benefit for the higher risk women.

This is a prime example of why subgroup analyses, PARTICULARLY when they weren't factored in to the original trial design, lack true power to prove a cause and effect if they contrast with the overall results. And Lilly did recently get into big trouble for promoting Raloxifene as heart protective ($36 million worth of trouble to be exact!) before clinical trial data were in. This example also illustrates why I personally think Wyeth, the makers of Premarin and Prempro, should be treading more lightly themselves since they too have overemphasized insignificant subgroup results of the WHI hormone trials.

Nevertheless, Raloxifene isn't all bad. It does lower breast cancer risk as well as fractures of the vertebra. It too, according to RUTH, did not increase uterine and endometrial cancer, which are a huge pitfall of Tamoxifen and unopposed estrogen use in non-hysterectomized women. And it certainly is a good thing that the necessary data are in to support the appropriate use of this drug. Like estrogen, Raloxifene has failed as a general health tonic and does pose some serious risks. But it's probably not as disheartening as it may seem, since we really are starting to enter an age of thinking where we realize a single pill isn't going to shield us from all ailments and keep us healthy.

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Jonathan Raymond
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Copyright 2005 Best Syndication                   Last Updated Saturday, July 10, 2010 09:46 PM