The NSAID and CVD Balancing Act

An Expert Interview With Daniel Solomon, MD

Linda Brookes; Daniel Solomon, MD


August 30, 2011

In This Article

Weighing the Risks and Benefits of NSAIDs When Managing Pain

Medscape: At the time of the FDA hearings into the COX-2 inhibitors, some patients were concerned about potentially losing rofecoxib, which they claimed was the only drug that gave them pain relief, and they said that they were willing to accept a small increase in cardiovascular risk for this.[23]

Dr. Solomon: It comes down to a benefit-to-risk ratio, and that is very much about your perspective. Is it cardiocentric (ie, anything that might cause damage to the heart should not be used)? Or is your perspective that of a physician trying to treat patients' symptoms -- their pain and their lack of function -- and trying to trade off the potential benefits and risks of these analgesics?

NSAIDs have been used for decades for this indication, and patients and randomized trials clearly speak to their benefits. When I discuss risks and benefits with patients in pain and explain that these drugs may increase their risk for a heart attack from 5 per 1000 per year to 6 or 7 per 1000 per year, they reply, "So, I should take it?"

How do you weigh the benefits and how do you weigh the potential risks? No one would say that these drugs are not risky -- we know they are risky. All of them, including the nonselective drugs, have significant risk for gastrointestinal bleeding. They all have significant risk for renal insufficiency. They all have a minimal risk for liver toxicity. This is very long list of potential risks, as with all drugs. But they have known benefits. And again, if you are a physician seeing patients with pain, you are sitting there saying, "What am I going to give for this patient's pain?"

When you are talking about cardiovascular risk, patients do not come in and say, "Is this drug risky for my heart?" They say, "Is it safe?" They are not asking about their heart, they are asking about overall safety. So we want to think about composite measures of safety. And patients are also asking about benefits: "Is it going to help me?" So the $64,000 question for a given patient is: which drugs have the best benefit-to-risk ratio? We do not really know, that is the bottom line, because most of the information, including the data from the study by Trelle and colleagues, does not tell us about people with different sets of risk factors. It only tells us about cardiovascular outcomes in the whole population.

Medscape: There has been concern about cardiovascular side effects of drug classes used in other areas of medicine, but a lot of attention has been focused on analgesics used in rheumatology.

Dr. Solomon: People focus on this because NSAIDs are such commonly used drugs, because there was a very high-profile issue with rofecoxib, and because cardiovascular risks in the elderly are a big deal. I completely agree with the perspective that even a 1% increase in risk multiplied in the millions of people who take NSAIDs is a public health issue. However, pain and disability are also public health issues.


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