April 1, 2008 (Chicago) -- Now there's scientific proof to back what many
doctors advise: If you take the popular painkiller Celebrex, use the lowest dose
possible to get relief, especially if you have risk factors for heart disease.
A pooled analysis of data from six studies shows that people who take 400
milligrams of Celebrex twice a day have three times the risk of having heart
attacks, other heart problems, strokes, or cardiovascular disease death,
compared with people who don't take the drug.
People who take 200 milligrams twice a day have nearly double the risk, and
those who take 400 milligrams once a day have a 10% higher risk of a
The researchers did not report on the once-daily 200-milligram dose of
Celebrex that is taken by most people with osteoarthritis because the
studies in the analysis did not include that dose.
At every dose, the more risk factors a person had for cardiovascular
disease, the greater the risk of Celebrex-related adverse events.
Celebrex a Last Resort for Heart Patients
"If you're at very low risk of cardiovascular disease, these data should
provide some comfort about taking [Celebrex]," says Scott D. Solomon, MD,
director of noninvasive cardiology at Brigham and Women's Hospital in
On the flip side, "patients at high risk for cardiovascular disease
should have a discussion with their doctor," he says.
Solomon tells WebMD that the analysis supports American Heart Association
(AHA) guidelines stating that people with heart risks should take the pain drug
Celebrex as a last resort and for the shortest possible time because of heart attack and stroke risk.
The guidelines, and Solomon, also say that caution could be warranted for
the long-term use of other nonsteroidal anti-inflammatory drugs (NSAIDs) --
with the exception of heart-protective aspirin.
Celebrex is a Cox-2 inhibitor, a type of NSAID. It's the only Cox-2
inhibitor on the market and already carries a "black box" warning that
notes heart attack and stroke risk.
The study, funded by the National Cancer Institute, involved the analysis of
six studies pitting Celebrex against placebo in nearly 8,000 patients being
treated for conditions other than arthritis.
American College of Cardiology past president Steven Nissen, MD, tells
WebMD that the fact that the 400-milligram once-daily dose raised risks by only
10% was "reassuring." Nissen is chairman of the department of
cardiovascular medicine at Cleveland Clinic.
He is heading another study, called PRECISION, which will compare 200
milligrams of Celebrex, ibuprofen, and naproxen in 20,000 patients
with osteoarthritis or rheumatoid arthritis and a high
risk for cardiovascular events. Results should be available in 2011.
Nissen says the 200-milligram, once-daily dose was chosen because it's used
by up to 90% of patients on Celebrex.
"PRECISION should help guide us regarding which one of these treatment
options is best," Solomon says.
In the meantime, he says treatment should be individualized based on your
risk of cardiovascular disease and your need for pain medication.
"All I can say at this point is that the 400-milligram, once-daily dose
was safest of the doses we tested. My guess is that lower doses would be safer,
but we can't yet say that with confidence," he says.