Study estimates number of excess cases of coronary heart disease cause...( t disease. Dr Graham comments:...),Health

Dr Graham comments: "An estimated 88,000-140,000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of rofecoxib. The US national estimate of the case-fatality rate (fatal acute myocardial infarction plus sudden cardiac death) was 44%, which suggests that many of the excess cases attributable to rofecoxib use were fatal.

"In the future, when trials show that a new treatment confers a greater risk of a serious adverse effect than a standard treatment, we must be much more careful about allowing its unrestrained use."

In an accompanying commentary Simon RJ Maxwell and David J Webb (University of Edinburgh, UK) write that after the withdrawal of Vioxx increased attention will now focus on the cardiovascular safety of other COX-2 inhibitors (coxibs).

Professor Webb concludes: "It now falls to the manufacturers, under the careful review of the regulatory authorities, to provide the evidence that this class of drugs is safe, if necessary including studies that directly address cardiovascular morbidity as a primary outcome. Indeed, the experience with coxibs underlines the need for full publication of all clinical trial data generated in support of newly licensed drugs."

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Contact: Joe Santangelo
j.santangelo@elsevier.com
1- 212-633-3810
Lancet
24-Jan-2005