Celebrex and Increased Cardiovascular Risk
12/17/2004
Editor's note: For the official SAA Position Statement on the COX-2 Inhibitors (Vioxx, Celebrex, Arcoxia, Bextra) please click here.
A study by the National Cancer Institute, the APC (Adenoma Prevention with Celecoxib) trial showed increased cardiovascular risk over placebo when taking Celebrex.
However, a second study, the Prevention of Spontaneous Adenomatopus Polyps (PreSAP) trial, showed no increased risk of cardiovascular risk when taking Celebrex.
The conflicting results come amidst the controversy surrounding the COX-2 class of anti-inflammatory drugs, which led to Vioxx being pulled from the market by drug maker Merck & Co., and Bextra having a new warning label attached because of the increased risk of cardiovascular events such as heart attack and stroke.
The maker of Celebrex, Pfizer, issued a statement on their website, Pfizer.com, addressing the findings. Pfizer CEO and chairman, Hank McKinnell, said in the statement, "These clinical trial results are new. The cardiovascular findings in one of the studies (APC) are unexpected and not consistent with the reported findings in the second study (PreSAP). Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world."
According to the National Cancer Institute (NCI), patients taking 400mg and 800mg of Celebrex daily had an approximately 2.5 fold increase in their risk of experiencing a major fatal or non-fatal cardiovascular event compared to those patients taking placebo in the APC trial. Because of this, NCI has suspended the use of Celebrex in the study.
The COX-2 inhibitors are a form of NSAID (non-steroidal ant-inflammatory drug), which are commonly prescribed in the treatment of ankylosing spondylitis and related diseases. Pfizer urged in its statement that patients using Celebrex should "discuss appropriate treatment options with their healthcare professionals. Physicians should factor this new information, as well as ulcer risks and gastrointestinal bleeding seen with traditional NSAIDs, into their prescribing decision."
Pfizer also said that the company will continue to work with the FDA on plans to "sponsor a major clinical study to further assess Celebrex in osteoarthritis patients at high-risk for cardiovascular disease."