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Rofecoxib did not provide unequivocal benefit over traditional NSAIDs
| The first 150 words of the full text of this article appear below. |
EDITOR
In their editorial Jüni et al say that celecoxib is no safer
than diclofenac or ibuprofen and that the CLASS authors "spun"
their analysis to suggest otherwise.1 They also state: "In contrast with the CLASS trial, the VIGOR trial, which was similar
in design and outcomes, found an unequivocal benefit of another
selective COX 2 inhibitor, rofecoxib, over traditional non-steroidal
anti-inflammatory agents [NSAIDs]."2
I disagree. Although serious gastrointestinal adverse effects were less frequent in rofecoxib users than in patients with rheumatoid arthritis treated with naproxen (number needed to treat to prevent one serious upper gastrointestinal event 191; 95% confidence interval 114 to 586), rofecoxib was in fact less safe than naproxen. The published version of the VIGOR trial focused on the narrow outcome of serious gastrointestinal complications.
The US Food and Drug Administration took the unprecedented step of
presenting its review of both the CLASS trial and the VIGOR trial
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