Correction

Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial

N Engl J Med 2006; 355:221July 13, 2006

Article

Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial (Original Article, N Engl J Med 2005:352;1092 - 1102) . 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 . . . .”

Citing Articles (9)

Citing Articles

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   Antonio González-Pérez, Luis Alberto García Rodriguez. 2010. Cardiovascular Toxicities of NSAIDS: Epidemiologic Aspects. , 287-312.
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   Colin Baigent, Carlo Patrono. (2008) Selective COX-2 inhibitors: where do we go from here?. The Lancet 372:9651, 1712-1713
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   John A Baron, Robert S Sandler, Robert S Bresalier, Angel Lanas, Dion G Morton, Robert Riddell, Erik R Iverson, David L DeMets. (2008) Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. The Lancet 372:9651, 1756-1764
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   Tarek A. Hammad, David J. Graham, Judy A. Staffa, Cynthia J. Kornegay, Gerald J. Dal Pan. (2008) Onset of acute myocardial infarction after use of non-steroidal anti-inflammatory drugs. Pharmacoepidemiology and Drug Safety 17:4, 315-321
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   Debabrata Mukherjee. (2008) Nonsteroidal Anti-Inflammatory Drugs and the Heart: What Is the Danger?. Congestive Heart Failure 14:2, 75-82
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   James M Brophy. (2008) Cardiovascular effects of cyclooxygenase-2 inhibitors. Current Opinion in Internal Medicine 7:1, 29-36
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   Vibeke Strand. (2007) Are COX-2 inhibitors preferable to non-selective non-steroidal anti-inflammatory drugs in patients with risk of cardiovascular events taking low-dose aspirin?. The Lancet 370:9605, 2138-2151
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   Scott D Solomon. (2007) Cyclooxygenase-2 inhibitors and cardiovascular risk. Current Opinion in Internal Medicine 6:1, 26-30
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   (2006) Adverse Cardiovascular Effects of Rofecoxib. New England Journal of Medicine 355:2, 203-205
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