Pfizer: Celebrex Trials Show No Increased Heart Risk
2/11/2005
Editor's note: For the official SAA Position Statement on the COX-2 Inhibitors (Vioxx, Celebrex, Arcoxia, Bextra) please click here.
This past week, Pfizer announced that an analysis of 41 of the pharmaceutical company's own trials on its COX-2 inhibitor, Celebrex (celecoxib), found no evidence of increased cardiovascular risk when taking the drug. In total, the studies involved over 44,000 patients.
This announcement comes after a 2004 study by the National Cancer Institute, the APC (Adenoma Prevention with Celecoxib) trial showed increased cardiovascular risk over placebo when taking Celebrex. Patients in that study were taking 400mg and 800mg daily, far higher than the normal recommended dosage. The study was subsequently halted.
Another trial in 2004, the Prevention of Spontaneous Adenomatopus Polyps (PreSAP) trial, showed no increased risk of cardiovascular risk when taking Celebrex.
In a 1999 study involving 425 patients taking Celebrex in order to assess its affect on Alzheimer's disease, participants suffered heart attacks at nearly four times the normal rate. Pfizer stated that not only had that study been public knowledge since 2000, but also that no conclusions regarding heart attack risk could be drawn from the trial because of the variations in the participant's medical history.
Pfizer admits that the 41 studies analyzed did not take into account external studies such as the APC trial.
About Celebrex (celecoxib)
Celebrex is a COX-2 inhibitor a non-steroidal anti-inflammatory drug that is sometimes prescribed for those with ankylosing spondylitis and related diseases. The drug comes in capsule form and is taken orally.