A coxib a day won't keep the doctor away

The cardiovascular implications of the present trial bear direct relevance to the interpretation of the gastrointestinal effects of lumiracoxib. As in other coxib trials,1,2,12 there was a significant decrease in the frequency of upper gastrointestinal ulcer complications in patients not taking low-...

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Bibliographic Details
Published in:The Lancet (British edition) 2004-08, Vol.364 (9435), p.639-640
Main Authors: Topol, Eric J, Falk, Gary W
Format: Article
Language:English
Subjects:
Anti-Inflammatory Agents, Non-Steroidal - adverse effects
Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
Clinical trials
Cyclooxygenase Inhibitors - adverse effects
Cyclooxygenase Inhibitors - therapeutic use
Diclofenac - analogs & derivatives
Drugs
Heart attacks
Hepatotoxicity
Humans
Middle Aged
Myocardial Infarction - chemically induced
Organic Chemicals - adverse effects
Organic Chemicals - therapeutic use
Osteoarthritis - drug therapy
Peptic Ulcer - chemically induced
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Summary:The cardiovascular implications of the present trial bear direct relevance to the interpretation of the gastrointestinal effects of lumiracoxib. As in other coxib trials,1,2,12 there was a significant decrease in the frequency of upper gastrointestinal ulcer complications in patients not taking low-dose aspirin (64 [0.92%] vs 14 [0.20%]). Thus, the number needed to treat to prevent one ulcer complication in this group of low-risk patients was 139. However, in the 24% of patients taking low-dose aspirin, the benefit of lumiracoxib on ulcer complications was no longer significant (19 [0.88%] vs 15 [0.69%]), again confirming the results of previous studies.2 Beyond the salutary effects on ulcer complications, the hepatotoxicity of lumiracoxib was manifest: the frequency of greater than 3-fold transaminase elevations was 2.57% (230) for lumiracoxib compared with 0.63% (56) for the two NSAIDs (hazard ratio 3.97 [2.96-5.32]). The authors claim that the dose of lumiracoxib tested was supratherapeutic, but why a higher than anticipated dose of lumiracoxib would have been studied or whether its hepatotoxicity was dose-dependent is unclear.
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(04)16906-7