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 drug.
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 The Cox-2 drug Vioxx was withdrawn from the market in the fall of 2004 after reports linked its long-term use to an increase in heart attack and stroke risk.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 2005.
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, MD.
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 procedures.
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.