Celebrex May Help Some Heart Patients
Study Shows the Cox-2 Drug May Help Patients With Drug-Coated Stents
Aug. 16, 2007 -- The anti-inflammatory drug Celebrex appears to improve
outcomes among heart patients treated with drug-coated stents, but experts say
the risk to patients may still outweigh the benefits.
In a newly reported study from
South Korea, patients who took Celebrex prior to and after receiving stents to
open clogged arteries were less likely to suffer another blockage in the
treated vessels within six months than patients who didn't take the
Reblockage due to scar tissue formation, known as restenosis, is a common
complication in heart patients treated with stents.
No Increase in Heart Risk
Researchers found no evidence of an increase in heart attacks or other
adverse heart events among Celebrex users, but the drug's safety in heart
patients remains an open question, a spokesperson for the American Heart
Association (AHA) tells WebMD.
Celebrex belongs to a class of painkillers known as Cox-2 inhibitors. The
Cox-2 drug Vioxx was withdrawn from the market in the fall of 2004 after
reports linked its long-term use to an increase in heart attack and stroke
risk. Another Cox-2 inhibitor, Bextra, was removed from the U.S. market in
Pfizer's Celebrex is the only Cox-2 inhibitor still sold in the U.S. Early
this year, AHA officials issued a statement calling for its use "only as a
last resort" in heart patients.
"Celebrex has not been entirely free of adverse events in previously
published trials, although its effects may not be as great as those seen with
some of the other more Cox-2 selective drugs in the class," says Wake
Forest University cardiology professor and AHA spokesman David Herrington,
The South Korean study included 274 patients with coronary artery blockages
scheduled to receive coated stents.
All patients got standard treatment including aspirin and another
anti-platelet drug Plavix, and roughly half were randomly assigned to receive
400 milligrams of Celebrex daily prior to having the stent procedure and for
six months afterward.
During this time, half as many patients who took the Cox-2 developed stent
restenosis (11% vs. 24%), and a third as many (5% vs.15%) needed repeat stent
The single cardiac death among the study participants occurred in a patient
who was not taking Celebrex.
"Administration of [Celebrex] for six months does not seem to increase
the risk of adverse cardiac events in the intermediate term when used with dual
anti-platelet therapy," wrote researcher Bon-Kwon Koo, MD, and colleagues
from the Seoul National University College of Medicine.
The study appears in the Aug. 18 issue of the journal The Lancet.
Heart Patients and Celebrex
Vincenzo Pasceri, MD, of Rome's Ospedale San Filippo Neri, says the study
was too small and the follow-up too short to prove that the Cox-2 inhibitor is
safe for heart patients treated with stents.
Pasceri co-wrote an editorial accompanying the study calling for larger and
longer studies to clarify the issue.
"We may be improving the outcome of restenosis at the expense of
increasing longer-term heart attack risk," Pasceri tells WebMD. "We
just don't know."
Herrington expressed the same concerns in an interview with WebMD.
"This study is certainly provocative, but the sample size was not large
enough and the duration of follow-up was not long enough to tell us with
certainty that Celebrex is both effective and safe for use in this patient
population," he says.