antiquity
12-27-2002, 12:19 PM
NEW YORK (Dec. 26) - The arthritis drug Celebrex is no more effective than a combination of standard treatments in preventing recurrent bleeding from ulcers, according to a study released on Thursday.
Celebrex, which is marketed by Pharmacia Corp. and Pfizer Inc., was designed to block plain without causing the ulcers and other bleeding problems linked to older painkillers. The bleeding is fatal to thousands of U.S. patients every year.
The study, published in Thursday's New England Journal of Medicine, involved 287 patients who had previously suffered ulcers and were considered at high-risk of developing new ones.
Among patients taking Celebrex, recurrent bleeding during the six-month study period was 4.9 percent. That was statistically no different from the 6.4 percent rate for patients taking a combination of the popular nonsteroidal painkiller diclofenac and ulcer drug Prilosec, made by AstraZeneca Plc.
The researchers concluded the slight difference was only enough to designate Celebrex "as effective as treatment with diclofenac plus (Prilosec), with respect to the prevention of recurrent bleeding," according to the New England Journal of Medicine.
"The results were unexpected. Neither regimen provided a good or even acceptable level of protection from recurrent ulcer bleeding," said an accompanying editorial in the publication written by Dr. David Graham of Veteran Affairs Medical Center in Houston.
Pharmacia spokeswoman Stephanie Fagan defended Celebrex, saying patients taking it alone fared as well as those taking the two other drugs.
"If you're a doctor and want to simplify things for your patients, you might well want to use one drug instead of two," she said.
Although the study reflects badly on Celebrex at first glance, the drug remains a safer alternative to many traditional painkillers, said Dr. Jay Goldstein, a researcher at the University of Illinois at Chicago who is a Pharmacia consultant.
He said the number of new ulcers during the trial might have been many times higher had patients not taken Celebrex or taken only diclofenac without also taking Prilosec -- a pill that prevents production of stomach acid.
"There's no way to know for sure because neither of the two treatment groups were tested against a group taking placebos," he said.
Celebrex and Merck & Co. Inc.'s Vioxx are members of a relatively new class of painkillers called COX-2 inhibitors that are intended to reduce the incidence of stomach-related side effects like ulcers that are suffered by patients taking older painkillers.
But since the two drugs were introduced a few years ago, a debate has raged over whether Celebrex and Vioxx significantly help protect against ulcers caused by other painkillers.
Pharmacia and Merck have lobbied the U.S. Food and Drug Administration with studies showing their drugs reduce the incidence of ulcers -- but for many doctors, the jury is still out.
In addition, insurers have balked at reimbursing for the two expensive drugs because they have not proven to kill pain any better than far-cheaper older drugs, such as aspirin, diclofenac and ibuprofen.
Pharmacia in June won a moderate victory when it said the label for Celebrex would be changed to show a generally favorable message about its lower risk of causing ulcers, but the label change did not show that the differences compared with two other drugs were statistically significant.
Celebrex has steadily gained market share over Vioxx in part because of a lingering concern that Vioxx raises the risk of heart-related side effects among patients taking the medicine. Some doctors are prescribing low-dose aspirin -- known to help prevent blood clotting that can lead to heart attacks -- along with Vioxx.
Celebrex generates more than $3 billion per year in sales for Pharmacia, which is being acquired by Pfizer. Vioxx produced sales of about $2.6 billion in 2001 for Merck.
Older painkillers, or non-steroidal anti-inflammatory drugs (NSAIDs), target two classes of proteins known as COX-2 enzymes and COX-1 enzymes. COX-1 enzymes which are known to protect the lining of the stomach. Celebrex and Vioxx are designed specifically target COX-2 and leave COX-1 alone, helping protect the stomach lining compared with other NSAIDs.
Shares of Pharmacia closed down $2.02, or 4.7 percent, to $40.98 Thursday. Pfizer fell $1.36, or 4.3 percent, to $30.02, also on the New York Stock Exchange, amid a 2 percent downturn for the drug sector. Those of rival Merck edged up 2 cents to $56.95.
16:18 12-26-02
Celebrex, which is marketed by Pharmacia Corp. and Pfizer Inc., was designed to block plain without causing the ulcers and other bleeding problems linked to older painkillers. The bleeding is fatal to thousands of U.S. patients every year.
The study, published in Thursday's New England Journal of Medicine, involved 287 patients who had previously suffered ulcers and were considered at high-risk of developing new ones.
Among patients taking Celebrex, recurrent bleeding during the six-month study period was 4.9 percent. That was statistically no different from the 6.4 percent rate for patients taking a combination of the popular nonsteroidal painkiller diclofenac and ulcer drug Prilosec, made by AstraZeneca Plc.
The researchers concluded the slight difference was only enough to designate Celebrex "as effective as treatment with diclofenac plus (Prilosec), with respect to the prevention of recurrent bleeding," according to the New England Journal of Medicine.
"The results were unexpected. Neither regimen provided a good or even acceptable level of protection from recurrent ulcer bleeding," said an accompanying editorial in the publication written by Dr. David Graham of Veteran Affairs Medical Center in Houston.
Pharmacia spokeswoman Stephanie Fagan defended Celebrex, saying patients taking it alone fared as well as those taking the two other drugs.
"If you're a doctor and want to simplify things for your patients, you might well want to use one drug instead of two," she said.
Although the study reflects badly on Celebrex at first glance, the drug remains a safer alternative to many traditional painkillers, said Dr. Jay Goldstein, a researcher at the University of Illinois at Chicago who is a Pharmacia consultant.
He said the number of new ulcers during the trial might have been many times higher had patients not taken Celebrex or taken only diclofenac without also taking Prilosec -- a pill that prevents production of stomach acid.
"There's no way to know for sure because neither of the two treatment groups were tested against a group taking placebos," he said.
Celebrex and Merck & Co. Inc.'s Vioxx are members of a relatively new class of painkillers called COX-2 inhibitors that are intended to reduce the incidence of stomach-related side effects like ulcers that are suffered by patients taking older painkillers.
But since the two drugs were introduced a few years ago, a debate has raged over whether Celebrex and Vioxx significantly help protect against ulcers caused by other painkillers.
Pharmacia and Merck have lobbied the U.S. Food and Drug Administration with studies showing their drugs reduce the incidence of ulcers -- but for many doctors, the jury is still out.
In addition, insurers have balked at reimbursing for the two expensive drugs because they have not proven to kill pain any better than far-cheaper older drugs, such as aspirin, diclofenac and ibuprofen.
Pharmacia in June won a moderate victory when it said the label for Celebrex would be changed to show a generally favorable message about its lower risk of causing ulcers, but the label change did not show that the differences compared with two other drugs were statistically significant.
Celebrex has steadily gained market share over Vioxx in part because of a lingering concern that Vioxx raises the risk of heart-related side effects among patients taking the medicine. Some doctors are prescribing low-dose aspirin -- known to help prevent blood clotting that can lead to heart attacks -- along with Vioxx.
Celebrex generates more than $3 billion per year in sales for Pharmacia, which is being acquired by Pfizer. Vioxx produced sales of about $2.6 billion in 2001 for Merck.
Older painkillers, or non-steroidal anti-inflammatory drugs (NSAIDs), target two classes of proteins known as COX-2 enzymes and COX-1 enzymes. COX-1 enzymes which are known to protect the lining of the stomach. Celebrex and Vioxx are designed specifically target COX-2 and leave COX-1 alone, helping protect the stomach lining compared with other NSAIDs.
Shares of Pharmacia closed down $2.02, or 4.7 percent, to $40.98 Thursday. Pfizer fell $1.36, or 4.3 percent, to $30.02, also on the New York Stock Exchange, amid a 2 percent downturn for the drug sector. Those of rival Merck edged up 2 cents to $56.95.
16:18 12-26-02