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Re: Efficacy of celecoxib, a COX-2-specific inhibitor, and naproxen in the management of acute ankle sprain: results of a double-blind, randomized controlled trial.

To the Editor: The article in the July 2004 issue of the Clinical Journal of Sport Medicine entitled ‘‘Efficacy of Celecoxib, a COX-2– Specific Inhibitor and Naproxen in the Management of Acute Ankle Sprain: Results of a Double-Blind, Randomized Controlled Trial’’ has reinforced previous studies comparing these agents in the management of more long-term medical problems such as osteoarthritis. In those studies, the COX-2–specific drugs celecoxib and rofecoxib showed relatively equal efficacy with traditional NSAIDs in the management of chronic musculoskeletal disorders. Since Dr. Petrella’s study, like the others, has confirmed the equal efficacy of the 2 classes of drugs, the practitioner must decide on appropriate therapy for ankle sprain based on other criteria, mainly the side effects of the 2 groups and their cost. In Dr. Petrella’s study, the only statistically significant side effect between the 2 groups was dyspepsia. While he lists this as a ‘‘clinically significant’’side effect, it is certainly debatable whether dyspepsia per se would cause a patient to discontinue use of a NSAID over the 7-day course of treatment. In longer-term studies, in fact, the incidence of clinically significant gastrointestinal side effects between traditional NSAIDs and COX-2 agents, while statistically significant, was a not-trivial 19% and 9%, respectively. Using a numbers-needed-to-treat analysis, one would therefore need to treat 10 patients with a COX-2 agent to avoid 1 clinically significant gastrointestinal side effect. In Dr. Petrella’s study, 25 patients would need to be treated with celecoxib to avoid 1 incidence of dyspepsia. Given the significantly higher cost of celecoxib versus naproxen, it is certainly questionable whether such use is appropriate. In Dr. Petrella’s discussion, he mentions theoretical safety issues from using traditional NSAIDs versus celecoxib in the management of acute painful conditions. Such issues (such as bleeding) have not been shown to be clinically significant when managing patients with acute injuries. In fact, the FDA’s analysis of the CLASS study revealed no significant differences in serious adverse events in patients treated with celecoxib or conventional NSAIDs. It would therefore seem reasonable to reserve the use of COX-2 agents to those patients who either have a history of adverse events related to conventional NSAID use or in those patients with a history of gastrointestinal bleeding, recognizing that the COX-2 agents carry a significant risk of such bleeding as well.