The COX-2 Report: the Good, the Bad, and the Unknown

摘要: On 1 December 1998, a U.S. Food and Drug Administration (FDA) advisory panel voted to approve celecoxib (Celebrex), the first selective cyclooxygenase (COX)-2 inhibitor, for treating arthritis pain [1]. Rofecoxib (Vioxx) was approved several months later [2], other COX-2 inhibitors are expected be shortly. These drugs have been classified as nonsteroidal anti-inflammatory (NSAIDs), which produce their therapeutic effects at least partially through inhibition of cyclooxygenase, enzyme that makes prostaglandins. Research over last decade has shown there 2 COX isoforms. COX-1 is constitutively produced; is, it present low levels all times prostaglandins thought protect stomach lining from damage. COX-2, on hand, expressed in brain kidney but (importantly) not gut. also induced by inflammatory stimuli produces contribute swelling inflammation [3]. Selective development years with expectation inhibit would efficacious older NSAIDs lower gastrointestinal toxicity. Prelicensure studies date support this presumption; however, definitive important clinical endpoints still progress [1,2]. By its 7th week market, Celebrex had surpassed Viagra, impotence medication, generating record numbers daily prescriptions early marketing [4]. Those who practiced medicine 1970s 1980s may remember mixture dread hope busy clinicians caring patients greeted introduction each new NSAID—dread about spate phone calls requesting drugs, touted more effective and/or easier stomach, indeed deliver promise. If sales reports any indicator, lot phones ringing. How should respond patient requests these drugs? When we replace old favorites “new improved” (but frequently expensive) alternatives? As decision, thinking using individual weigh known benefits risks. In decision involving or devices, consider unknown Thus, I classify my remarks into 3 categories: good, bad, (which hopefully ugly).