Celebrex Strikes Out

There’s some disturbing news for Pfizer in the latest edition of the New England Journal of Medicine. Two company-funded clinical trials that tested Celebrex’s ability to prevent the recurrence of colon polyps showed the drug doubled the risk of heart attacks and stroke compared to people who took aspirin for the same purpose.

While that’s not as bad as Vioxx, which quadrupled the heart attack risk compared to people taking another pain pill (naproxen in that case), it’s still a pretty strong signal that this drug has no place in most persons' medicine chests.

The trials accomplished what they set out to do: they lowered the chance that people who have had colon polyps removed after routine colonoscopies would have a recurrence of the growths, which are often benign. But the ultimate benefits – which is colon cancer prevention – were relatively minor: if a thousand persons took the drug for three years, 1.5 persons on Celebrex would get cancer compared to 3.1 persons who took no drug at all. But a thousand persons taking low-dose aspirin would get almost exactly the same benefit – just 1.9 would get colon cancer.

But what would happen on the “cardiovascular events” side of the ledger for these thousand-person groups? The thousand-person group taking no drug at all would suffer 17.7 heart attacks and strokes, according to the data in the trials. The Celebrex group, meanwhile, would suffer 28.8 events and the low-dose aspirin group would experience only 12.1 events. One obvious conclusion from this trial is that low-dose aspirin is still one of the most effective tools we have for reducing one’s risk of cardiovascular disease, and we now know it is also somewhat effective at reducing the recurrence of colon polyps.

In an accompanying editorial to the studies (from which the above numbers were drawn), University of Washington professors Bruce Psaty and John Potter concluded that “celecoxib (Celebrex) has no role as a chemopreventive agent either in patients with nonfamilial colonic adenomas or in the general population.”

I suspect some cardiologists may take an even harder line, perhaps even calling for Celebrex’ removal from the market. Let’s hope we hear what they have to say in the morning papers.