For a decade, researchers have been concerned about how the arthritis drug celecoxib would affect the heart compared to two other drugs that are commonly prescribed for the condition. A new study shows that these concerns were unwarranted.
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The study, published online Sunday in the New England Journal of Medicine, shows that celecoxib, which is sold under the brand name Celebrex, does not confer excess cardiovascular risk compared with ibuprofen and naproxen, two non-steroidal anti-inflammatory drugs (NSAIDs) widely prescribed to treat arthritis.
In fact, celecoxib is associated with fewer cardiovascular adverse events than naproxen and ibuprofen, says the study, which is called the PRECISION trial. The results show that the drug also appears to cause lower rates of gastrointestinal and renal problems — and perhaps even death rates.
Getting the facts
PRECISION was a 10-year study prompted by the 2004 market withdrawal of a drug that worked similarly to celecoxib, after disclosure of the drug’s association with increased risk of heart attack and stroke.
In response, the Food and Drug Administration (FDA) required the manufacturer of celecoxib to conduct a long-term safety study as a condition of keeping the drug on the market.
Most experts believed celecoxib was probably somewhat worse than the two NSAIDs for cardiovascular safety, says Steven Nissen, MD, Chairman of Cardiovascular Medicine at Cleveland Clinic and lead author of the PRECISION trial.
“The answer is now in — and there was no increase in risk,” Dr. Nissen says. “In fact, the actual number of cardiovascular events that occurred was smaller with celecoxib than with ibuprofen or naproxen.”
That’s useful new information for the more than 50 million Americans who suffer from arthritis pain.
No increase in risk
Researchers in the PRECISION study treated more than 24,000 people with osteoarthritis and rheumatoid arthritis who were at high risk for heart disease.
Participants were split into three groups and received daily prescription doses of either celecoxib, ibuprofen or naproxen. They were treated for an average of 20 months and followed for about three years.
The primary results show that celecoxib did not increase the risk of heart complications.
Researchers also looked into other known complications from these drugs — stomach ulcers, kidney problems and overall risk of dying.
Secondary results show that celecoxib had generally lower risk of these complications when compared to ibuprofen and naproxen.
Dr. Nissen says the results were surprising — even more so when it came to naproxen.
“Many guidelines and commentators over the years have recommended to heart patients that they take naproxen,” he says. “Naproxen was believed to be the safest of the drugs and we didn’t find that.
“Like everyone else, I thought celecoxib probably would prove to be a bit worse than the other NSAIDs in cardiovascular risk. The fact that it went in the other direction was very surprising.”
Prescription strength drugs, used long-term
It’s important to note that the medication doses in the study were prescription-strength and that study participants used the drugs over a long period of time.
Dr. Nissen says people should not be excessively fearful of taking the occasional over-the-counter ibuprofen or naproxen for aches and pains — as long as they are taking the recommended dose.
“It is sobering and it does require people to understand that they need to stay within the dosing guidelines for those over-the-counter drugs,” Dr. Nissen says.