Rofecoxib reduces colorectal adenomas

Last Updated: 2007-01-24 16:58:01 -0400 (Reuters Health)

NEW YORK (Reuters Health) - The cyclo-oxygenase (COX) -2 inhibitor rofecoxib significantly reduces the risk of colorectal adenoma recurrence, but the agent showed considerable toxicity.

"Rofecoxib has been withdrawn from the market worldwide, so in a narrow sense, the study has no clinical implications," lead investigator Dr. John A. Baron told Reuters Health. However," he added, "the study does show that selective COX-2 inhibitors interfere with carcinogenesis in the large bowel."

In the December issue of Gastroenterology, Dr. Baron of Dartmouth Medical School, Hanover, New Hampshire and colleagues studying 2587 patients with a recent history of histologically confirmed adenoma. They were randomized to receive rofecoxib 25 mg or placebo daily.

Follow-up at 3 years showed that adenoma recurrence was significantly lower in rofecoxib patients (relative risk 0.76). There also was a significant reduction in the risk of advanced adenomas. The protective effect was greater in the first year (relative risk, 0.65) than in subsequent years (0.85).

However, the active treatment group had a greater relative risk of thrombotic cardiovascular events (1.89) and gastrointestinal problems including perforation and bleeding (4.91). Overall, significantly more rofecoxib patients (27.5%) had serious adverse events than did placebo patients (22.2%).

Despite the unavailability of rofecoxib, Dr. Baron concluded that "since virtually all NSAIDs studied seem to have this chemopreventive potential, we have a valuable insight into the process of colorectal carcinogenesis and perhaps how to stop it."