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Vioxx went mostly to patients who didn't need it, Stanford researcher says

ded target population: "therapeutic creep." In the case of COX-2s, not only does this expansion mean that millions of people paid more for a drug without reaping a substantial medical benefit, but it now appears they unnecessarily exposed themselves to the risk of heart problems, Stafford said.

COX-2 inhibitors have been at the center of a controversy since last September when Vioxx was pulled from the market after clinical trials showed that it posed significant risks of heart attacks. Similar findings were also recently reported for Celebrex, although it is still available.

What makes the widespread use of COX-2s so troubling is that they aren't any more effective at controlling pain than NSAIDs. While they were seen as a welcome alternative for those at greatest risk of gastrointestinal side effects from NSAIDs, they are more expensive. A daily dose of Vioxx at $2.64 costs about six times as much as a daily dose of ibuprofen at 42 cents, according to a 2002 compendium of drug prices.

For the study, Stafford and his colleagues looked at national databases that tracked patient visits to their physicians between 1999 and 2002 and the types of medications being either continued or prescribed. Additionally, they used a tool developed at Stanford in the 1990s to categorize patients according to their risk of gastrointestinal bleeding from NSAIDs.

According to the study, 73 percent of the patients had either a very low or low risk of GI bleeding from NSAIDs, meaning that there was no pressing medical reason for them to switch to COX-2 inhibitors. However, this was the group where the greatest growth in COX-2 use occurred. The study showed the number of physician visits associated with COX-2 use in these patients increased from approximately 9.5 million in 1999 to 20.9 million in 2002, accounting for 63 percent of the growth in the drugs' use during that time.

Patients most likely to benefit from COX-2s-those with either moderate o
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Contact: Susan Ipaktchian
650-725-5375
Stanford University Medical Center
21-Jan-2005


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