Doctors treating people for chronic pain should avoid using all medications -- at least at first -- the American Heart Association advised yesterday in guidelines designed to have a significant impact on the use of medications known as nonsteroidal anti-inflammatory drugs, or NSAIDs.
The scientific statement said that, with the exception of aspirin, there is now strong evidence that NSAIDs are associated with an increased risk of heart attacks and stroke. If 100 patients who have had heart attacks in the past or are at risk for heart disease take these drugs for a year, researchers would expect to see six additional deaths in this group. NSAIDs reduce fever, pain and inflammation.
The statement expressed particular concern over a subgroup of these drugs known as Cox-2 inhibitors. The only drug in this group currently on the market in the United States is Celebrex.
The professional association laid out a step-by-step approach that is very different from the way physicians typically have approached treating chronic pain and inflammation.
"In the past, many physicians would prescribe the Cox-2 drugs first," said Elliott Antman, a professor at Harvard Medical School who led a group of experts assembled by the heart association to study the issue. "We are specifically recommending that they should be used as a last resort."
"This is a very firm statement we are making," he added. "It is our belief, hope and desire that physicians will take our advice, and by doing so it is our belief and hope that we will reduce the number of patients who suffer heart attacks and strokes."
Patients should be treated first with nonmedicinal measures such as physical therapy, hot or cold packs, exercise, weight loss, and orthotics before doctors even consider medication, said the AHA scientific statement published in the journal Circulation.
Patients who get no relief after those measures have been exhausted can be considered for drug therapy, but doctors should try drugs only in a certain order, the statement said:
"In general, the least risky medication should be tried first, with escalation only if the first medication is ineffective. In practice, this usually means starting with acetaminophen or aspirin at the lowest efficacious dose, especially for short-term needs."
While most patients are likely to be helped by those drugs, a smaller number may need to try a drug such as naproxen. Patients who require additional help should be given other nonprescription painkillers such as ibuprofen, and only after that option has been exhausted should physicians consider Cox-2 inhibitors, Antman said in an interview.
The heart association visualized a giant inverted pyramid in which patients who need the riskier drugs make up an ever-smaller number of patients.
Cox-2 inhibitors such as Celebrex, Vioxx and Bextra were once seen as wonder drugs that reduced pain and inflammation without causing the stomach problems of earlier drugs. But Antman said convincing evidence now shows that these drugs not only increase the risk of heart problems but also seem to do little to reduce serious stomach problems.
The Food and Drug Administration has issued a number of warnings and alerts about the drugs, but Antman said many physicians and patients still clamor for them.
"These drugs were heavily marketed to the medical community and patients through direct-to-consumer advertising, and they were very widely used and [are] still used quite widely," Antman said. "Fewer and fewer numbers of patients should receive the riskiest drugs. What has been done by many physicians is to make them the first line of treatment."