antifaust

A month ago, Merck announced that it was pulling out its product Vioxx (Rofecoxib) because data from the unpublished APPROVe (Adenomatous Polyp Prevention on VIOXX) trial pointed to an increased risk for cardiovascular events, such as heart attacks and strokes. Recently, Pfizer announced that a clinical trial involving patients who underwent bypass surgery also showed increased risk for mycardial infraction and stroke for those receiving their COX-2 inhibitor Bextra (Valdecoxib). We’ve been prescribing the newer COX-2 inhibitors because of their gastrointestinal safety, but these recent announcements suggest a class effect that cannot be ignored.

I have not read the full text report of APPROVe, but even if the increased cardiovascular risk is indeed significant (I hear it isn’t), is there really need for a pull out of the newer coxibs? I’m with Medpundit on this one: Eric Topol’s scathing editorial against Merck was too self-congratulatory. Other factors could be contributing to the observed effect, such as age and — as RangelMD pointed out — lack of anti-platelet meds. I’ll have more to say about this once the APPROVe trial gets published: we need to get our hands on the raw data before we jump to conclusions.

All this talk about drug side effects reminded of a lecture one of our Adult Medicine consultants gave us in med school. He mentioned a study which illustrated how differently physicians and patients perceive risk. The study involved aspirin and warfarin, medications that help reduce the risk of stroke in patients with atrial fibrillation. Both drugs have a particularly nasty adverse effect though: they increase the incidence of gastrointestinal bleeding. The authors were able to demonstrate that patients were more willing to accept the risk of bleeding than physicians. In particular cases, the conclusion that a particular benefit outweighs the risks should factor in the perceptions and values of the patient. I’m not saying that we should continue to prescribe COX-2 inhibitors to all patients with pain (personally, I still use NSAIDs for most of my patients), but I don’t think they should be forgotten either. Would you not mention COX-2 inhibitors to an elderly patients whose arthritis does not respond to NSAIDs? What if he / she already had an episode of gastrointestinal bleeding because of NSAIDS — would you still not consider the COX-2 option?

On a related note: there have been efforts from Pfizer to defend their other COX-2 drug Celebrex (Celecoxib. A day or two after the Vioxx recall, a drug rep gave us a press release arguing that there is no evidence that the drug is linked to adverse cardiovascular events.

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