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Pfizer says it sees no safety concerns in Celebrex studies
 
 
  NEW YORK (Reuters) - Pfizer Inc. said on Friday that three long-term studies seeking additional uses for its popular arthritis drug Celebrex (celecoxib) have turned up no cardiovascular safety concerns and that it plans to continue those trials to their conclusion.
 
Pfizer released the information a day after Merck & Co. pulled its rival COX-2 inhibitor Vioxx (rofecoxib) from the market when a study found long-term use of the medicine doubled the risk of heart attack and stroke. The news raised concern about the entire class of COX-2 inhibitors.
 
"In light of recent events we really want to reassure doctors who we work with and patients who take our product that we don't really have a cardiovascular concern," said Dr. Mitch Gandelman, Pfizer's vice president for worldwide medical, oncology and pain information.
 
The Merck study that led to the Vioxx withdrawal was designed to see if the drug could prevent recurrence of colon polyps. Increased heart risk began to appear after 18 months of use and was double in patients taking Vioxx for 3 years.
 
Pfizer said two of its ongoing Celebrex studies were for the same indication, while a third was testing the drug for use against Alzheimer's disease. The three studies, which are testing Celebrex at various doses versus a placebo, involve more than 6,000 patients, Pfizer said.
 
In one of the colon polyp trials, more than 900 patients had been taking Celebrex for 3 years with no evidence of increased cardiovascular risks, Gandelman said. In the other, 325 patients had reached the 3-year mark without turning up significant safety concerns.
 
The studies are expected to follow those patients for five years.
 
"Each COX-2 inhibitor has a distinct chemical structure and we would not expect them to have the same side-effect profile," Joe Feczko, Pfizer's president of worldwide development, said in a statement issued by the New York drugmaker.
 

 

 
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