Vanderbilt research shows high doses of popular pain reliever prescribed despite heart risk 7-9-2004
VUMC researchers have found that doctors continue to prescribe Vioxx at high doses for a long time, even though it raises the risk for serious heart problems./Anne Rayner
The evidence is growing: chronic, high-dose consumption of the arthritis pain reliever Vioxx can raise blood pressure and the risk of serious heart problems.
Yet a “substantial number” of patients continue to be prescribed high doses of the drug, according to researchers at
The researchers counted the number of prescriptions for non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, naproxen, Celebrex and Vioxx, given to participants over age 49 in
Of 40,000 participants who had prescriptions for any NSAID as of
The 50-milligram dose has not been shown to be more effective than lower doses of the drug in relieving chronic pain, and it has been linked to an increased risk of heart attacks. “Such use should be discouraged,” the researchers concluded in the June issue of the journal Pharmacoepidemiology and Drug Safety.
Vioxx (the brand name for rofecoxib) and Celebrex (celecoxib) are selective COX-2 inhibitors. They relieve inflammation by blocking the cyclooxygenase-2 enzyme, but they don’t inhibit the related COX-1 enzyme, which protects the stomach lining. Therefore they don’t irritate the stomach as much as NSAIDs that block both enzymes.
“They cause fewer ulcers,” explained the study’s lead author, Marie R. Griffin, M.D., MPH, professor of Preventive Medicine and Medicine. “That’s a good thing in many ways, although there’s a lot of people using them who are pretty low risk for GI (gastrointestinal) events.”
COX-2 inhibitors also cost $80 to $100 per month, compared to about $10 to $15 for a month’s supply of generic naproxen.
“We think that the rationale is that if 25 milligrams works well, then 50 milligrams is going to work better,”
“This is really common with a lot of drugs, that there’s a ceiling on the effective dose … But unfortunately, there’s usually not a ceiling on the side effects.”
In a study of TennCare participants published in the journal Lancet that year, the researchers reported patients on high doses of Vioxx had nearly twice the rate of serious heart problems, including heart attacks and heart-related deaths, compared to patients not on the drug.
Other groups have reported similar findings among high-dose Vioxx users: an increased risk of heart attack and congestive heart failure, a rise in blood pressure and a greater incidence of edema, or swelling, in the arms and legs, which can put extra strain on the heart.
Some doctors won’t prescribe Vioxx for patients at risk for developing high blood pressure, because the drug could make that condition more difficult to control,
Of the TennCare patients in the Vanderbilt study who were receiving over 25 milligrams of Vioxx a day, 15 percent had been treated for congestive heart failure during the previous 12 months, and 22 percent had been treated for other forms of heart disease, the researchers reported.
“Educating all clinicians about this is a very difficult task. There are so many drugs out there,”
“You hate to make people jump through hoops to get things but … it should be harder to prescribe drugs that would potentially do harm.”
Others who contributed to the Vanderbilt study were Patrick G. Arbogast, Ph.D., assistant professor of Preventive Medicine; James R. Daugherty, M.S., computer systems analyst in the department; and David J. Graham, M.D., of the U.S. Food and Drug Administration.
The study was supported in part by a grant from the U.S. Centers for Education and Research on Therapeutics.
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