Cox-2 Drugs: Less CV Risk Than Other NSAIDs?
7 CommentsBy Ed Silverman // February 26th, 2008 // 12:56 pm
That’s the conclusion in a piece in the latest issue of the Journal of Cardiovascular Pharmacology and Therapeutics. The only exception is naproxen, according to the authors, who reviewed a meta-analysis published two years ago in the British Medical Journal, 138 clinical trials and observational studies involving Merck’s Vioxx, Pfizer’s Celebrex and Bextra, and such widely used painkillers as ibuprofen and diclofenac.
The upshot is that the Cox-2 inhibitors - the Merck and Pfizer drugs - didn’t post a statistically significant greater risk of cardiovascular disease than the other non-steroidal anti-inflammatories. However, the Merck and Pfizer drugs did pose a greater risk than taking nothing, notes Charles Hennekens, a professor at Florida Atlantic University who helped prove that aspirin can benefit the heart and a member of the FDA panel that reviewed the Cox-2 drugs in early 2005. This is the study. Whether it gains any traction remains to be seen.
“When I was on the panel, I was struck by the epidemiological claims of much larger risk, but the randomized evidence didn’t come until later,” Hennekens says. “So we decided to look at all the evidence and this commentary essentially says what was published in the BMJ two years ago, but didn’t receive wide attention. Although we looked at more than the clinical trials. The conclusion is that the Cox-2 drugs offer no greater risk of cardiovascular disease than the other NSAIDs, except naproxen.”
We should note that Hennekens has served as a consultant for numerous drugmakers, including Pfizer and Merck. And he has also provided ‘expert advice’ to Pfizer concering its litigation. In fact, the ties to the drugmakers among numerous FDA panel members in early 2005 caused a controversy. Meanwhile, his co-author, Steve Borzak, has received speaking fees from Merck.
Someone
Before making such a statement they need to ensure that they had access to the raw data and not just the results of the published studies….
No job is finished until all the paperwork is done…
Brian
More people have been injured / killed by aspirin and the NSAIDs than vioxx and any COX-2 inhibitor..GI side effects have plagued these drugs for decades but no one seems to notice.
Justice in Michigan
A couple of years ago, the aspirin/GI risks were talked about all the time (recall Singh’s testimony in Nov ‘04). Then it turned out that Vioxx’s advantage was neglible and Celebrex’s non-existent (at least based on CLASS when the full data set was made public).
The author of this study comes in with a hundred red flags around him. They may or may not mean anything. It will be interesting to see.
Brian
Thousands dead every year from GI effects but it wasn’t seen until NSAID were widely used. You wouldn’t expect to see the benefit of COX-2 clearly in a standard clinical trial because the numbers are too small. Same with CV effects are they real or not…plus the RA ,OA population is already at higher risk…
CV
Ed,
I believe that you should be very careful with a statement like “less CV risk” in the headline, which will be widely interpreted as lower by a statistically significant margin. I’m quite sure that this is not correct since the quote from the article says “no greater”, which can mean slightly less than, no different from, the same as, or slightly greater than, but certainly does not mean less than or greater than.
By the way, as a physician, I think that low-dose aspirin(81mg) is all the vast majority of people need to receive anti-platelt effect. A small portion may need 160mg. If a patient can’t take aspirin, then a little bit of naproxen is probably the best alternative.
CV
Bob Freeman
Many years ago I worked in the NSAID area, specifically safety issues among the various drugs in the class. There are definitely “safer” NSAIDS especially in the population at risk (over 50, alcohol intake, smokers). The problem with gastropathy is that about 40% of the cases are asymptomatic although clinically signficant bleeds.
Frankly, I think the CoX-II designation is a creation of marketing as far GI and CV risks are concerned.
Ed Silverman
Hi CV,
I understand. That’s why I deliberately used a question mark - to underscore any uncertainty the findings may engender. But I wasn’t trying to be inaccurate, either, of course. Then again, the difference between slightly less and less can have statistical meaning, but less of something is still less, at least when it comes to headlines.
In any event, thanks for pointing that out and I will be mindful going forward.
Regards
ed