The National Institutes of Health (NIH) today announced that it has suspended a large clinical trial testing whether the COX-2 Celebrex can prevent colon polyps. Those taking the drug had an increased risk of heart attacks compared to volunteers taking placebo, results which echo similar results with another COX-2 inhibitor -. Vioxx, which forced him to be uprooted from the market on September 30
Elias Zerhouni, director of the NIH, which funded the suspended trials, and dozens of others to prevent cancer or Alzheimer's disease with Celebrex, said in a press conference that he has ordered a review of all studies funded by NIH COX -2 inhibitors.
Celebrex, manufactured by pharmaceutical giant Pfizer, has been under a microscope since the pharmaceutical company Merck announced it was withdrawing Vioxx from the market. A study testing the Vioxx capacity to stem polyps in 2,0 volunteers found that after 18 months, participants on Vioxx were twice as likely to suffer a heart attack or stroke than those taking placebo. The withdrawal of Vioxx has raised questions about whether the problems with Vioxx could infest other COX-2 inhibitors as well. Earlier this month, the FDA added a warning to the COX-2 inhibitor Bextra, which against its use in patients undergoing bypass surgery.
Pfizer has defended Celebrex as safe, but is now evaluating new data. The study of the National Cancer Institute funded, involving 2,000 people, was to test whether Celebrex could prevent colon polyps, a precursor of colon cancer in patients at risk. After further examination after the withdrawal of Vioxx, and the addition of cardiovascular experts to the security of the test supervisory board data, the DSMB concluded that patients taking a high dose of Celebrex had an increase of 3.4 times the risk of heart attacks or stroke versus placebo; those on a moderate dose had a 2.5-fold increase risk
Since the announcement this morning of the suspension of the trial, at least two related trials were temporarily halted. a colon prevention study polyp began recruiting this year and aimed for 1,0 participants, and breast cancer treatment trial who also started this year with the aim to recruit 2,700 women, said Charles Geyer, director of medical Affairs for the National Surgical adjuvant Breast Bowel project (NSABP), a group that performs cancer trials and is itself funded by the NIH. So far, the NIH is apparently not suspend other trials of Celebrex, including two that have more than 1,000 participants - at least not immediately, in part, Zerhouni said, because another Celebrex trial that closely resembles suspended the trial did not find the same problems. But investigators are holding their breath. "There are big questions to be answered about whether we continue," said Peter Lance University of Arizona in Tucson, who heads a large colon polyp prevention trials, expected to enroll 1,0 people.
0 Komentar