A study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped by an independent Data Safety and Monitoring Board (DSMB).
Analysis showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo.
A September 2004 report revealed that the COX-2 inhibitor rofecoxib (Vioxx™) caused a two-fold increased risk of cardiovascular toxicities in a trial to prevent adenomas.
In response to this, additional cardiovascular expertise was added to the safety monitoring committees at the request of the Steering Committees for this trial.
The APC is a study of more than 2,000 people who have had a precancerous growth (adenomatous polyp) removed.
Our overwhelming commitment is to advance the health and to protect the safety of participants in clinical trials
Researchers randomized participants to take either 200 mg of celecoxib twice a day, 400 mg of celecoxib twice a day, or a placebo for 3 years.
The trial began in early 2000 and is scheduled to have been completed by Spring 2005.
Investigators at the 100 sites in the APC trial located primarily in the United States, with a few additional sites in the United Kingdom, Australia, and Canada, have been instructed to immediately suspend study drug use for all participants on the trial.
Participants will remain under observation for the planned remainder of the study.
“Data from the report on rofecoxib (Vioxx™) informed us of the need to focus on specific cardiovascular issues, and our Institutes brought in the experts to do so," said Elias A. Zerhouni, M.D., NIH Director.
“Our overwhelming commitment is to advance the health and to protect the safety of participants in clinical trials."
"We are examining the use of these agents in all NIH-sponsored clinical studies. In addition, we are working closely with our colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug.”