HOME >> MEDICINE >> NEWS
NIH halts use of COX-2 inhibitor in large cancer prevention trial

The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex Pfizer, Inc.) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) 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.

Additional cardiovascular expertise was added to the safety monitoring committees at the request of the Steering Committees for this trial after a September 2004 report that the COX-2 inhibitor rofecoxib (Vioxx) caused a two-fold increased risk of cardiovascular toxicities in a trial to prevent adenomas. The APC is a study of more than 2,000 people who have had a precancerous growth (adenomatous polyp) removed. They were randomized to take either 200 mg of celecoxib twice a day, 400 mg of celecoxib twice a day, or a placebo for three 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, although the 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
'"/>

Contact: John Burklow / Don Ralbovsky
301-496-5787
NIH/Office of the Director
17-Dec-2004


Page: 1 2

Related medicine news :

1. Success of new treatment halts international blood pressure drug trial
2. Researchers identify brain protein that halts progression of Alzheimers
3. New oral medication halts blindness in AIDS patients
4. Enzyme halts muscle waste in mouse models of most-common childhood muscular dystrophy
5. COX-2 inhibitors associated with blood pressure elevation
6. COX-2 product offers good and bad news in test tube strokes
7. COX-2 inhibitor increases the risk of heart attack in elderly adults with no history of heart attack
8. More studies on risks and benefits of COX-2 inhibitors published in Archives of Internal Medicine
9. Special JAMA commentary on lessons learned from troubles with COX-2 inhibitors
10. Estrogen-associated COX-2 pathways explain protection from heart disease in female mice
11. COX-2 inhibitor could be safest anti-inflammatory drug for older people

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/15/2019)... ... ... Nashville Fertility Center (NFC) is proud to announce that Kristin Van Heertum ... to treating general infertility, Dr. Van Heertum offers expertise in fertility surgery and treatment ... Van Heertum joining the practice and believes she is the perfect fit. According to ...
(Date:10/11/2019)... , ... October 11, 2019 , ... A Topping Out ... new headquarters facility by general contractors Adolfson & Peterson Construction. The event celebrated reaching ... at 8190 Midtown Road in Dallas. The first of its kind in Texas, STA’s ...
(Date:10/10/2019)... (PRWEB) , ... October 10, 2019 , ... Caring.com, a ... Report on the Best and Worst Places for Seniors to Live. All 50 states ... engagement, transportation, quality of life and workforce development. , According to the ...
(Date:10/8/2019)... ... 2019 , ... What unique insights can three former Surgeons General of the ... the nation? That question will be answered at ICAA 2019: Shaping the Future of ... event will take place October 10-12, 2019, at the Gaylord Palms Resort and Convention ...
(Date:10/8/2019)... CA (PRWEB) , ... October 08, 2019 , ... Dr. ... gum disease in San Jose, CA experience relief from this common and treatable condition. ... in order to save adults from living with uncomfortable symptoms, including tender and bleeding ...
Breaking Medicine News(10 mins):
(Date:10/8/2019)... ... October 08, 2019 , ... ... farmers a wider range of novel, microbial-based crop protection products. , Under the ... natural product starting points. In a first for the agriculture industry, Corteva will ...
(Date:10/8/2019)... ... October 08, 2019 , ... ... today announced that FocalPoint Holdings, a privately-held investment and management firm specializing ... more than 8,000 ophthalmology and optometry providers Luma Health’s patient relationship technology ...
(Date:10/8/2019)... ... October 08, 2019 , ... AdventHealth Wesley ... and provide safer, convenient options for patients who require treatment. The hospital is ... enhanced mammography is used to detect tumors in dense breasts that may not ...
Breaking Medicine Technology:
Cached News: