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Previous Volume 355:221 July 13, 2006 Number 2

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Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial . In the reported results, the test for proportionality of hazards used linear time rather than the logarithm of time that was specified in the Methods section. Analysis using the logarithm of time leads to the following changes:

The first complete paragraph on page 1097 should have read, "In a post hoc assessment, visual inspection of Figure 2 suggested that the Kaplan–Meier curves separated 18 months after randomization. However, the results of an overall test of the proportional-hazards assumption for the entire 36-month observation period did not reach statistical significance (P=0.07)."

Therefore, statements regarding an increase in risk after 18 months should be removed from the Abstract (the sentence "The increased relative risk became apparent after 18 months of treatment; during the first 18 months, the event rates were similar in the two groups" should be deleted, as should the sentence beginning "There was earlier separation . . .") and from the Discussion section (the sentence "In post hoc analyses, the increased relative risk of adjudicated thrombotic events was first observed after approximately 18 months of treatment" should be deleted).

In addition, the first full paragraph on page 1100 should have read, "In our randomized, placebo-controlled trial, we found an increased risk of confirmed thrombotic events associated with the use of rofecoxib. Visual inspection of the Kaplan–Meier curves suggested that there was an increased frequency of thrombotic events associated with rofecoxib therapy after 18 months. Other investigators reported . . . ."

This Correction was published at www.nejm.org on June 26, 2006.

PDF PDA Full Text Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article by Bresalier, R. S.

This article has been cited by other articles:

• McGettigan, P., Henry, D. (2006). Cardiovascular Risk and Inhibition of Cyclooxygenase: A Systematic Review of the Observational Studies of Selective and Nonselective Inhibitors of Cyclooxygenase 2. JAMA 296: 1633-1644 [Abstract] [Full Text]  
• Nissen, S. E., Furberg, C. D., Bresalier, R. S., Baron, J. A. (2006). Adverse Cardiovascular Effects of Rofecoxib. NEJM 355: 203-205 [Full Text]  
• (2005). Risk from Vioxx in a Colorectal-Adenoma Prevention Trial. Journal Watch Cardiology 2005: 2-2 [Full Text]