A couple of months back I wrote a post discussing the concerns I and many others have regarding the return of severe gastrointestinal side effects as a result of the increasing use of the so-called traditional anti-inflammatories. This is of course to be expected due to the fears so many patients have now of the sole COX-2 inhibitor remaining on the market in the United States–Celebrex.
Many of my patients are simply refusing to take Celebrex out of fear it “might kill me.”
The issue of whether the use of COX-2 inhibitors with low-dose aspirin is reasonable for patients at risk of cardiovascular events raised its weary head once more the last few weeks. This time, a provocative article appeared in the December 22, 2007 issue of the British medical journal “The Lancet.”
The author, a rheumatologist at Stanford University, feels that COX-2 inhibitors are preferable to traditional anti-inflammatories (such as Motrin and Voltaren) in patients with chronic pain and cardiovascular risk requiring low-dose aspirin.
However, other physicians disagree with this conclusion, stating that there is no data showing that the COX-2 inhibitors are safe to use in a population at risk for cardiovascular illness and complications.
In fact, the issue of heart safety will only be resolved through a prospective randomized trial. And, as luck would have it, there is such a trial now ongoing.
This trial, known as PRECISION, is enrolling 20,000 patients with osteoarthritis or rheumatoid arthritis AND a high risk for significant cardiovascular problems. The patients entering the study will be assigned to groups who will take either ibuprofen, naproxen, or celecoxib. Approximately 50% of the study subjects will be taking aspirin.
When this study is completed in 2011 we should finally have definitive information regarding the safety and efficacy of the traditional anti-inflammatories versus the COX-2 inhibitor Celebrex in a population at high risk for cardiovascular illness.
And we should all not forget the gastrointestinal problems that can come with the use of an aspirin a day. One of the early Celebrex studies showed that taking low-dose aspirin with Celebrex cancelled out the gastrointestinal benefits of the COX-2 inhibitor Celebrex.
As you can imagine, this further increases the patient’s pharmacy budget. And so the patient would probably do just as well with a traditional anti-inflammatory with, say, Nexium if that patient is already on aspirin.
I don’t know about you, but all this has me scratching my head.