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.