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September 28, 2010

The Danger of NSAID painkillers - Diclofenac: Similar CV cardiovascular risk to Rofecoxib in health people

June 8, 2010 inCirculation: Cardiovascular Quality and Outcomes.
Background: The Cox-2 inhibiting anti-inflammatory (NSAID) drug Vioxx (Merck) was famously pulled from a host of markets following research that showed a marked rise in cardiovascular complications and deaths in patients who were on the drug.  Interestingly, other Cox-2 inhibitors, using very similar ingredients were allowed to remain on the market.  "NSAID" stands for "non-steroidal anti-inflamatory drug" which really means a non-cortizone related drug.

In their study, Emil Loldrup Folbøl et al investigated the dangers of similar drugs that remain on the market, including ibuprofen (in high doses), naproxen and Celebrex (Pfizer).  The study involved about 1 million Danes, who had filled at least one prescription of a relevant drug and fulfilled the other selection criteria.

They found a significant increase in death rates with odds ration 1.91 and 1.66 from use of Diclofenac and Rofecoxib, respectively. The sample size was insufficient to make any conclusions about the use of Celebrex. 
There was indications of increased risk of stroke (fatal and non-fatal) with high doses of ibuprofen (odds ration 1.29), Naproxen, however,  was not associated with an increased risk of cardiovascular failures.
 Their study also revealed that all NSAIDs, except Celebrex, dramatically increased the risk of serious increased internal bleeding. They also concluded that these various complications varied with the dose taken, meaning that patients who either took more or took it for a longer time were more likely to have complications.

My comments:  This story brings forth a whole host of possible comments, ranging from issues with governmental oversight, to positioning of inter-professional relationships, to public health and information issues - but I'll restrain myself.
I will choose just to concur with the authors' comments that most painkillers have some kind of side effect, ranging from negative to deadly and that most of them should be avoided as much as possible and for as long as possible. Wonder what the results would have looked like if they had focused in only on people who had taking these drugs for a year or longer ?   Having said that, in my daily work I do mention the possibility of managing pain temporarily with NSAIDs while we take care of the underlying causes. But that is as a temporary measure to help the patient cope in their daily life while we get them better - not as an actual treatment for the problem - and that is a major difference.