Heart Attack Support Group

Risk of heart attack and stroke

There has been much concern about the possibility of increased risk for heart attack and stroke in users of NSAID drugs, particularly COX-2 selective NSAIDs such as Celebrex. since the withdrawal of the COX-2 inhibitor rofecoxib (Vioxx) in 2004. Like all NSAIDs on the U.S. market,Celebrex carries an FDA-mandated "black box warning" for cardiovascular and gastrointestinal risk. In February 2007, the American Heart Association warned that Celebrex should be used "as a last resort on patients who have heart disease or a risk of developing it", and suggested that paracetamol (acetaminophen), or certain older NSAIDs, such as naproxen, may be safer choices for chronic pain relief in these patients.[4]

The cardiovascular risks of Celebrex are controversial, with apparently contradictory data produced from different clinical trials. In December 2004, "APC", the first of two trials of Celebrex for colon cancer prevention, found that long-term (33 months) use of high-dose Celebrex (400 and 800 mg daily) demonstrated an increased cardiovascular risk compared with placebo.[5] A similar trial, named PreSAP, did not demonstrate an increased risk.[6] Still, the APC trial, combined with the recent Vioxx findings, suggested that there might be serious cardiovascular risks specific to the COX-2 inhibitors. On the other hand, a large Alzheimer's prevention trial, called ADAPT, was terminated early after preliminary data suggested that the nonselective NSAID naproxen, but not Celebrex, was associated with increased cardiovascular risk.[7] In April 2005, after an extensive review of data, the FDA concluded that it was likely "that there is a 'class effect' for increased CV risk for all NSAIDs".[8]

Two studies on the cardiovascular risks of Celebrex and other NSAIDs were meta-analyses, published in 2006. The first of these, published in the British Medical Journal, looked at the incidence of cardiovascular events in all previous randomized controlled trials of COX-2 inhibitors, as well as some trials of other NSAIDs. The authors concluded that a significant increased risk did exist for Celebrex, as well as some other selective and nonselective NSAIDS. However, the increased cardiovascular risk in Celebrex was noted only at daily doses of 400 mg or greater. [9] A second meta-analysis published in the Journal of the American Medical Association, which included observational rather than randomized studies (mostly at lower doses) did not find an increased cardiovascular risk of Celebrex vs placebo.[10]

To establish more conclusively the true cardiovascular risk profile of Celebrex, Pfizer has agreed to fund a large, randomized trial specifically designed for that purpose. The trial, centered at the Cleveland Clinic, has a planned enrollment of 20,000 high-risk patients. Celebrex will be compared with the non-selective NSAIDS naproxen and ibuprofen.[11] Since all patients have arthritis, ethical considerations make it difficult to have a placebo group. This trial has just begun enrollment according to the Clinical Trials database, and is not scheduled to be completed until 2010. Ultimately, this trial will help answer the question as to whether Celebrex has a riskier cardiovascular profile compared with naproxen or ibuprofen.

hope this helps
Rich

Hi Rich,
Thanks for the info. I called my cardi today and talked to the nurse who said a week or two would be fine, but not beyond that. I really don't know why I'm having all this shoulder pain. It also hurts when I take a deep breath. If things aren't improved by Monday I'm calling my PCP or cardi and making an appointment. I don't see how it can be heart-related, however.

Thanks again for your post.
Pam

pk

i have rhumatoid arthritis and was on celebrex---after my heart attack the RA doctor and cardiologist stopped the celebrex immediately--no nsaids whatsoever!

hope this helps

gary

Gary and Rich,

Thanks for your posts. I went to my PCP today and he took me off the Celebrex. Although my cardi nurse said it would be okay for a week or two I had some concerns. PCP did an EKG and everything looked okay. Put me on prednisone and I already feel much better. Pain is mostly gone. He also gave me some tylenol with codeine in case I need it. I go back Tuesday for a check up.

Thanks again for your help! You guys are great!
Pame