Celebrex - a so-called COX-2 inhibitor provides 2.5 times greater risk of serious heart problems so long-term randomized double-blind study. Shares of Pfizer fell 17% in value in one day.
December 17, 2004: Source: Medscape, thanks to Bob who sent us this messageYesterday it was announced that Celebrex - cyclo-oxygenase (COX) -2 inhibitor celecoxib - a so-called COX-2 inhibitor risk of serious heart problems increased by a factor of 2.5. The first reaction was that the share of producer Pfizer at the fair in the U.S. fell by 17%. Probably we suspect Celebrex from the market are. What we still always surprised that this kind of study results from animal experiments are never reported or even after Phase I and Phase II studies? Again, the hand seems to have been informed by objective research, as so often seems to happen. And the Dutch media? Neither NRC nor Volkskrant newspaper or what I've realized that study reported results. Independent reporting on current terms, because this post was yesterday afternoon around 18.00 hours known Overheard in economic overview on Radio 1. Achereenvolgens artilel uti press release from Reuters Health and Medscape about Celebrex
Medscape Medical News 2004. © 2004 Medscape
December 17, 2004 - The cyclooxygenase (COX) -2 inhibitor celecoxib (Celebrex) More Than doubled the risk of cardiovascular events in subjects enrolled in the adenoma Prevention with Celecoxib (APC) study, celecoxib maker Pfizer Inc. said today.
The large randomized, double-blind, placebo-controlled, multicenter study was designed to Investigate whethere celecoxib Could Prevent colon cancer in people who had had colon polyps Previously. Subjects who fired celecoxib was 2.5 times as many fatal and nonfatal heart attacks as Those Who did not take the drug.
Patients enrolled in the trial are being Told to Stop Taking Medication study.
Accor ding to a statement from Pfizer, the Prevention of Colorectal Sporadic Adenomatous Polyp (PreSAP) trial, another ongoing study looking at celecoxib whethere CAN Prevent colon cancer, "revealed no cardiovascular risk Greater Than placebo." This trial Used The Same The Same Heart Measures and safety monitoring board as the APC trial.
Celecoxib is in The Same class of drugs as rofecoxib (Vioxx). Vioxx was with drawn from the market after a colon cancer prevention trial found it Increased the risk of heart attacks. Pfizer Also Manufactures valdecoxib (Bextra), another COX-2 inhibitor.
, Br> "Pfizer Taking immediate steps to fully understand the [APC study] results and Rapidly Communicate new information to regulators, physicians, and patients around the world," Pfizer CEO Hank McKinnell says in a news release.
Investigators in the APC trial gift patiënten 400 mg and 800 mg doses of celecoxib per day. People who take celecoxib for arthritis are Prescribed doses of 100 mg to 400 mg per day.
The APC and PreSAP trials have enrolled some 3600 people. Some Of Them Have Been Taking celecoxib for More Than Four Years. Pfizer notes That some 2000 people are enrolled in another study looking at whethere celecoxib can-preventDefault Alzheimer's disease in high-risk people. Some 750 acres of These Patients Taking 400 mg daily or delecoxib. As or December 10, this study's safety review board Decided to proceed with the study.
Pfizer says it learned of the heart Findings from the APC study last night. The National Cancer Institute (NCI) is conducting the study. An NCI spokesman tells WebMD thats the trial's safety monitoring board with Until 11:30 pm last night.
The impact of the New Findings is not yet clear. Celecoxib is the ninth best-selling drug in the U.S., with 2003 sales of 2.6 Billion, According To Forbes.com.
Reviewed By Michael Smith, MD.
This press release from Reuters Health on the same message:
Celebrex Trial Stopped After Heart Attacks
By Ransdell Pierson
NEW YORK (Reuters) - Pfizer Inc. on Friday said ITS popular Celebrex arthritis drug doubled the risk of more Than heart attack in a large cancer-prevention trial, a setback Comes That just weeks after Merck & Co.. Recalled ITS similar drug Vioxx due to heart safety risks.
Shares of Pfizer, a component of the Dow Jones industrial average, Fell 14 percent in morning trade following news of the trial, sponsored by the National Cancer Institute.
Merck on Vioxx Recalled Sept. That study found 30 after a long-term use of the drug doubled the risk of heart attack and stroke. Both Celebrex and Vioxx belong to a class of drugs Known as COX-2 inhibitors.
"This does not herald well for COX-2 inhibitors in general," Ira Loss, an analyst at Washington Analysis, said of the Celebrex trial results. "The sense was Celebrex That leg is somehow differentiate from the others."
Dr. Richard Hayes, a logistic cardio at New York University, Told Reuters, "This raises my concern about Celebrex and all the COX-2 inhibitors, so I will no longer be prescribing Any of Them."
A Pfizer spokesman said the company has no plans to pull Celebrex off the market. It is one of the drug maker's biggest products, with 2003 sales of $ 1.9 billion. Also the company sells a newer COX-2 inhibitor, Bextra, That had sales last year of $ 687 million.
The U.S. Food and Drug Administration had no immediate comment.
Merck continues to sell Its Own newer COX-2 drug, Arcoxia, overseas. Arcoxia HAS not bone Launched in the United States, however, Concerned Because of safety.
Pfizer shed about $ 30 billion in market capitalization in late-morning trading, ITS stock falling to $ 24.80 on the New York Stock Exchange and dragging down the Dow Jones Industrial Average as well as Other pharmaceutical stocks. Pfizer is off about 30 percent this year.
MORE TROUBLE FOR COX-2s
Pfizer said the Celebrex trial Involved patiënten takingcare 400-milligram and 800-milligram daily doses of the drug to tumors preventDefault That grow from glandular tissue, Known As adenomas. The anti-inflammatory drug was being Tested on the theory That is a cause inflammation or cancer.
Both Vioxx and Celebrex work by selectively blocking a protein called COX-2 That Has Been linked to inflammation. They Were Both Launched in 1999 and Quickly Became top-selling drugs, Helped by massive television and print advertising. Also on Friday said Pfizer That was Celebrex Not Shown to Increase Heart Risk in a second long-term trial designed to see if the drug could-preventDefault colon polyps. Negative finding in a similar trial led to the Withdrawal of Vioxx.
New York-based Pfizer said National Cancer Institute officials Decided to halt the Celebrex trial on adenomas after confirming "an approximately 2.5-fold Increase" in the risk of fatal or non-fatal heart attack in patiënten Taking the drug, compared with a patiënten takingcare placebo.
"They (the NCI) to compromise security to follow patients in the study," said Pfizer spokesman Paul Fitzhenry, although patients want no longer be Given Celebrex. "We alerted the Food and Drug Administration last night about The Findings," said Fitzhenry. He said he could-not elaborate on Those discussions. That is argued HAS Pfizer Celebrex and Vioxx from Chemically differential does not carry The Same safety risk.
Amid concerns about the safety of all COX-2 inhibitors after the withdrawel Vioxx, Pfizer plans to start a major new trial next year to verify the safety of Celebrex in heart-arthritis patients who have had a recent heart attack.
The company HAS Also Defended Bextra's safety, although Pfizer's newer treatment raised the risk of stroke and heart attack in two small clinical trials of Patients Taking it after coronary bypass surgery.
Recently the company updated Bextra's label, package insert to warn thats it CAN cause a rare and fatal skin disorder Sometimes called Stevens-Johnson syndrome. (Additional reporting by Edward Tobin and William Borden in New York and Susan Heavey inWashington)
