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Study: No Long-Lasting Vioxx Heart Risk

Risk Goes Away When Vioxx Use Stops; Low-Dose Celebrex Seems Safe
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How Safe Is High-Dose Celebrex? continued...

Now, in an early release from the April 5, 2005 issue of Annals of Internal Medicine, Brophy's team provides more information. They found that:

 

  • Celebrex did not increase heart attack risk.
  • Vioxx did indeed increase heart attack risk.
  • Taking low-dose Vioxx -- 25 milligrams per day or less -- raised heart attack risk by 24%.
  • Taking high-dose Vioxx -- more than 25 milligrams per day -- increased heart attack risk by 73%.
  • People who took Vioxx in the past, but who stopped taking the drug, did not have a higher risk of heart attack.
  • Taking aspirin along with low-dose Vioxx protected against increased risk of heart attack, but taking aspirin along with high-dose Vioxx offered no protection at all.
  • Traditional NSAIDs did not increase heart attack risk. A report in December 2004 linked Aleve (naproxen) to an increase in heart attacks and strokes, but this study found no connection.

 

A close look at the findings does not give Celebrex a totally clean bill of health, says rheumatologist Axel Finckh, MD, a researcher at Brigham and Women's Hospital in Boston, who has studied Cox-2 inhibitors.

Finckh suggests that the findings provide added evidence that it is Cox-2 inhibition -- and not some other effect -- that underlies Vioxx's heart toxicity. Celebrex, too, is a Cox-2 inhibitor, although it is not nearly as potent as Vioxx in this regard.

"Very few of the Canadian patients took more than 200 milligrams per day of Celebrex -- and in clinical trials, the only heart risk was seen in those taking 400-800 milligrams per day," Finckh notes. "From this study we can see that lower doses of Celebrex seem to be relatively safe. I don't think we can say anything about higher doses of Celebrex."

And while Brophy's study shows that aspirin can remedy the heart toxicity of Cox-2 inhibitors, Finckh says this makes little clinical sense. Patients who do not suffer stomach and intestinal side effects from aspirin might as well take the equally effective and less-costly traditional NSAIDs.

"It abolishes the gastrointestinal security of the Cox-2 drugs to take aspirin," Finckh says. "If you need aspirin for heart protection, you might as well take a traditional NSAID for pain relief."

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