Are Anti-Inflammatory Drugs Safe? I’m Confused About The American Heart Association Comments. By Nathan Wei At Isnare.com Ezine Articles

The use of non-steroidal anti-inflammatory drugs to treat musculoskeletal problems has come under intense fire from the cardiology community. It is their position that these drugs often pose an unacceptably high risk of cardiovascular events.

A recent paper from the American Heart Association presents their position. Obviously, the thoughts of a practicing rheumatologist are going to be at loggerheads with that of cardiologists. Their ten-point program along with my comments in parentheses follows:

1. For patients with musculoskeletal symptoms whose symptoms are not controlled by non-pharmacological approaches, pharmacological treatments should then be considered. (When choosing any medication, both safety and efficacy should be considered. While cardiovascular risk is a possibility, the treating physician should take into account the patient’s lifestyle and quality of life. In addition, the likelihood of cardiovascular risk needs to be accounted for. A patient with a prior history of cardiovascular events or who has many risk factors for cardiovascular events is not a good candidate for anti-inflammatory drugs therapy. However, a patient of the same age with no cardiovascular risk factors whose arthritis limits his ability to function may need to take anti-inflammatory medicine to achieve the lifestyle he desires.)

2. From both the patient's and the physician's perspectives, one needs to balance the risks and benefits of medications for pain relief. (The risks and benefits will vary from patient to patient as noted above.)

3. 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. Despite the potential for abuse, a role remains for narcotic medications for short-term pain relief. (In reality, acetaminophen is not very helpful for most significant arthritis pain. And it also carries the risk of significant kidney and liver toxicity over the long run. Also, the use of narcotic analgesics brings on another measure of risk... namely habituation and addiction.)

4. Current evidence indicates that selective cyclooxygenase (COX)-2 inhibitors have important adverse cardiovascular effects that include increased risk for myocardial infarction, stroke, heart failure, and hypertension. (The reality is that the only COX-2 drug on the market, Celebrex, has no higher cardiovascular risk than any other non-COX-2 drug. Vioxx- a drug that was removed by the FDA- obviously did. Unfortunately, the Vioxx experience spread a black cloud over all COX-2 drugs.)

5. The risk for these adverse effects is likely greatest in patients with a prior history of or at high risk for cardiovascular disease. In these patients, use of COX-2 inhibitors for pain relief should be limited to patients for whom there are no appropriate alternatives, and then, only in the lowest dose and for the shortest duration necessary. (I actually agree with this statement. But again, there is no inherent risk of Celebrex over the remaining non COX-2 non-steroidal anti-inflammatory drugs. In a patient with cardiovascular risk factors, any anti-inflammatory drug carries a risk.)

6. More long-term data are needed to fully evaluate the extent to which these important adverse cardiovascular effects may potentially be offset by other beneficial effects of these medications. (Now... this is a stupid statement. The question is this: Will this drug improve my quality of life enough that I’m willing to chance the risk of a cardiovascular event? The only person who can answer that question is the patient.)

7. More data are also needed on the cardiovascular safety of conventional NSAIDs. Until such data are available, the use of any COX inhibitor, including over-the-counter NSAIDs, for long periods of time should only be considered in consultation with a physician. (All non-steroidal anti-inflammatory drugs, whether they are COX-2 selective or not, have a risk attached to them. A study- the PRECISION trial- is currently underway to determine the relative risk of anti-inflammatory drugs and cardiovascular events in patients with arthritis.)

8. Evidence indicates that ibuprofen, but not rofecoxib (a COX-2 inhibitor), acetaminophen, or diclofenac, interferes with aspirin's ability to irreversibly acetylate the platelet COX-1 enzyme. Patients taking immediate release low-dose aspirin (not enteric coated) and ibuprofen 400 mg should take the ibuprofen at least 30 minutes after aspirin ingestion, or at least 8 hours before aspirin ingestion to avoid any potential interaction. (This is an important point. Patients taking ibuprofen should take note. Rofecoxib (Vioxx), which was associated with an unacceptable risk, is no longer available.)

9. The debate about the increased risk of cardiovascular events attributed to the selective COX-2 inhibitors and the nonselective NSAIDs is part of a broader national debate about drug safety. (Truer words were never said. The PRECISION trial should help answer some of these issues.)

Optimal safety evaluation of drugs requires timely and complete submission of scientific data from the manufacturers, as well as increased funding and authority granted to the Food and Drug Administration by Congress. (Duhhh)

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