Reuters is reporting that Pfizer is stopping a Celebrex trial due to heart problems with the drug.
Pfizer Inc. on Friday said a government-sponsored cancer-prevention trial of its blockbuster arthritis drug Celebrex was halted after patients taking it had more than twice as many heart attacks as patients taking a placebo.
Pfizer Inc. on Friday said patients taking its blockbuster arthritis drug Celebrex in a long-term cancer-prevention trial had more than twice the number of fatal or non-fatal heart attacks as those taking a placebo.
Shares of Pfizer, a component of the Dow Jones industrial average, dipped 17 percent in early trade after the unfavorable details emerged on the large, long-term trial, sponsored by the National Cancer Institute.
Pfizer said the trial involved patients taking 400-milligram and 800-milligram daily doses of Celebrex to prevent adenomas, tumors that grow from glandular tissue. The anti-inflammatory drug was being tested on the theory that inflammation is a cause of cancer.
Celebrex is in a class of drugs known as a Cox-2 inhibitor. Recently, Vioxx has been yanked from the market because of similar heart problems. The whole class of drugs is now suspect. At this point it appears that Celebrex is less dangerous than Vioxx but more dangerous than other NSAIDs. A recent University of Pennsylvania study reported the following:
Penn Epidemiological Study Shows Difference In Cardiovascular Effects Between Vioxx And Celebrex
Philadelphia, PA -- In the first epidemiological study designed and executed specifically to determine the heart-attack risk associated with COX-2 inhibitors rofecoxib (Vioxx) and celecoxib (Celebrex), researchers at the University of Pennsylvania School of Medicine found a greater risk of heart attack associated with Vioxx than Celebrex, although neither of the two drugs showed a statistically significant elevated risk of heart attack relative to people who did not use the drugs. In addition, the researchers found discrete clinical differences between the two COX-2 inhibitors -- which suggest that the effect of the drugs on the cardiovascular system should be viewed separately rather than as a single class of drugs. This study appears online December 7, 2004 and will be published in the February 1, 2005 print issue of the Annals of Internal Medicine.
The study, which also compared the heart-attack risk between COX-2 inhibitors and older nonsteroidal anti-inflammatory drugs (NSAIDs), found a lower risk with NSAIDs rather than COX-2 inhibitors. The NSAIDs studied included aspirin, ibuprofen (Advil and Motrin), and naxproxen (Aleve).
"Our results suggest that there is a marked difference between rofecoxib and celecoxib relative to heart-attack risk," said Stephen E. Kimmel, MD, Associate Professor of Medicine at Penn and lead author of the study. Use of rofecoxib was associated with 2.72-higher odds of heart attack than was the use of celecoxib. That difference, Kimmel suggests, may be due to a number of factors, including differences in selectivity for the COX-2 isoenzyme, blood pressure, endothelial function, and oxidative stress. Rofecoxib was also associated with a higher odds of heart attack compared with older NSAIDs.
It would seem that this is all new, but it is not. The following was reported in the British Medical Journal in 2001.
Treatment with certain COX 2 inhibitors, non-steroidal anti-inflammatory drugs that relieve the pain associated with arthritis, may increase the risk of heart attack, according to a retrospective analysis of two separate marketing studies.
The research comes within weeks of the National Institute for Clinical Excellence approving these types of drug for use in the NHS in England and Wales. The institute acknowledged in a recent technology appraisal guidance bulletin (No 27, July 2001; www.nice.org.uk) that there is such a risk and that COX 2 inhibitors should not be prescribed routinely to patients with cardiovascular disease.
Researchers from the Cleveland Clinic Foundation in Ohio analysed the cardiovascular event rates in two randomised multicentre trials. They also looked at myocardial infarction rates in the placebo group (23407 patients) in a meta-analysis of four large aspirin studies.
They found that the annual myocardial infarction rate in the aspirin placebo group was 0.52% This compared with 0.74% (P=0.04) for the COX 2 inhibitor rofecoxib (Vioxx) in the Vioxx gastrointestinal outcomes research (VIGOR) study and 0.80% for the inhibitor celecoxib (Celebrex) in the celecoxib long term arthritis safety study (CLASS) (JAMA 2001;286: 954-9).
Bottom line: if you are using any Cox-2 inhibitor, see your doctor.
The following comment was left on this page.
Title: Generic Drugs
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Description:Celebrex from Canada (Celecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) known as a COX-2 inhibitor. Celebrex from Canada (Celecoxib) is used to relieve pain and swelling (inflammation).
We are waiting your response
Thankyou
Stupid robots. I wonder who would want to get Celebrex after reading this.
Posted by: Rich | February 14, 2005 at 11:34 AM