“This study will change the way I prescribe it.”
Investigators at Cleveland Clinic recently concluded that after studying the safety of the pain reliever celecoxib (Celebrex) for more than 10 years, it poses no more risk to heart health than ibuprofen (Advil or Motrin) or naproxen (Aleve). It also causes fewer stomach and kidney issues than ibuprofen, one of the most popular pain relievers available without a prescription.
This was a surprise to the study’s authors who maintained a long-held belief that naproxen was the safest.
“The study was very well done, sponsored by the Cleveland Clinic, which is an indicator of excellence,” said orthopedic surgeon Jesse Affonso MD. “Whenever you see a study coming out of the Cleveland Clinic, you take notice.”
Celecoxib is a prescription drug used primarily to treat the pain and inflammation from arthritis. It received FDA approval in 1998. Concerns began to emerge soon after, when there was a surge in the incidence of both fatal and non-fatal heart attacks among the users of a similar drug, Vioxx.
“Celebrex has always been under the cloud of Vioxx. They both belong to a group of drugs called COX-2 inhibitors. I have been hesitant to prescribe it, never using it for more than a short course of pain relief,” said Dr. Affonso. “This study will change the way I prescribe it.”
While Vioxx was removed from the market in 2004, Celebrex was allowed to stay in use, with a contingency. The FDA mandated that maker Pfizer commission a long-term safety study.
The Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen and Naproxen (PRESICION) trial concluded a decade-long evaluation in 2014. The goal was to see if Celebrex was at least as safe as the other two drugs.
The PRECISION trial included 24,081 patients in 926 centers across 13 countries. Participants all had arthritis and were either at high risk for, or diagnosed with, cardiovascular disease.
The results were published in The New England Journal of Medicine on November 14, 2016.
Investigators found that celecoxib outperformed naproxen and ibuprofen on several measures, including:
- It had the lowest rate of cardiovascular events (188), either fatal or non-fatal, as compared to naproxen (201) and ibuprofen (218).
- More people taking ibuprofen (92) experienced serious kidney disease than either naproxen (71) or celecoxib (57), which was the safest.
- There were 25 percent more deaths from all causes among the naproxen group (163) than those taking celecoxib (132), which was the lowest.
- The fewest incidents of gastric bleeding or ulcers occurred among users of celecoxib (86), followed by naproxen (119) and ibuprofen (130).
Is Taking Celecoxib Safe For Regular Use?
Cape Cod Healthcare cardiologist Mallory Hatfield MD still isn’t so sure.
“I have had patients calling and asking about this study,” said Dr. Hatfield. “And what I tell them is the answer isn’t that simple.”
Dr. Hatfield commends the makers of Celebrex for trying to evaluate the safety of all of these drugs, especially since ibuprofen and naproxen are taken without a doctor’s prescription.