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Uproar over COX-2 inhibitors alters landscape of drug trials.(Clinical Rounds)
CHICAGO -- Recent events surrounding selective cyclooxygenase-2 inhibitors will have far-reaching implications for future drug trials, Gary S. Hoffman, M.D., said at a symposium sponsored by the American College of Rheumatology.
Drugs under investigation for chronic diseases such as arthritis will require longer trials and follow-up than in the past, in part because of their likely long-term use among the patients who need them.
"We can no longer endorse or not endorse these drugs based upon short-term studies, some of which have been as short as 6 weeks or 12 weeks and usually, certainly, less than a year," said Dr. Hoffman, a member of the Food and Drug Administration's arthritis advisory committee.
NSAID trials now will include cardiovascular and thrombotic events among the adverse events they monitor.
But this raises questions as to whether there are other adverse events (AEs) such as cancer, autoimmune effects, or neurocognitive dysfunction that are beyond our current knowledge, said Dr. Hoffman, professor of medicine and chair of rheumatic and immunologic diseases at the Cleveland Clinic Foundation.
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