Increased Risk Of Death For Post-Heart Attack Patients Taking COX-2 Drugs
In mid-November 2005 it was reported that Merck's Vioxx and Pfizer's Celebrex, as well as some similar painkillers, increase the risk of death among patients who had a previous heart attack, especially when the painkillers were taken in high doses. These findings from a Danish study were released November 13, 2005 at the American Heart Association conference in Dallas, Texas.
The findings come from a study which was funded by the Danish Heart Foundation and the Danish Pharmaceutical Association. This Danish study is reportedly the first to look at patients with known heart problems. The study's lead researcher, Dr. Gunnar Gislason, of the Bispebjerg University Hospital in Copenhagen, said at the Dallas conference this study indicates that patients who have heart disease should not use Celebrex or Vioxx, also called COX-2 inhibitors.
The November 2005 Danish study results showed that heart disease patients 25 milligrams ("mg") of Vioxx or more on a daily basis had a 5.03 times greater risk of dying when compared to those patients not taking any COX-2 drug. For Celebrex, those post-heart attack patients taking 200 mg of Celebrex or more daily had a 4.24 times greater risk of dying, while patients taking 200 mg of Celebrex or less had a 1.7 times greater risk.
A Merck spokesman, Chris Loder, was "quick" to criticize the Danish study -- insofar that no one at Merck, according to Mr. Loder, had seen Dr. Gislason's study. Merck's spokesman pointed out that randomized controlled clinical trials are the preferred way of establishing the safety of a drug, and that this study conducted by Dr. Gislason was not of this type. Mr. Loder asserted, "Randomized controlled clinical trials are the gold standard."
As is well-known by now, Merck pulled Vioxx off the market in September 2004 after such a clinical study showed an apparent increased risk of cardiovascular problems, including heart attacks and strokes, for patients who took Vioxx for at least 18 months. Merck maintains, however, that neither the earlier study nor any other randomized controlled clinical trial has established that there is an increased risk of death from using Vioxx, i.e., Merck disputes what this Danish study headed up by Dr. Gislason has found, now.
According to news reports, no Pfizer executives were immediately available to comment on the Danish study and its findings about Celebrex.
The Gislason study was based on the researchers' review of medical records for more than 58,000 Danish patients who had their first heart attack between 1995 and 2002.
(Posted by: Tom Lamb)