NEJM Correction: Possibility of Cardiovascular Risk with Shorter Vioxx Courses

The New England Journal of Medicine corrected a 2005 study on complications among patients taking Vioxx, suggesting that the risk for thrombotic cardiovascular events might have occurred earlier in treatment than the study originally concluded.

The APPROVe study originally reported that the increase in risk "became apparent" after 18 months on Vioxx (rofecoxib). Merck removed the drug from the market in September 2004 based on the trial's data.

The correction acknowledged a misstatement about the test used to calculate the hazards over time. A separate analysis by the journal's statistical consultant said "one could not conclude from the data that a shorter [less than 18-month] course of rofecoxib is safe." The Associated Press quoted NEJM editor-in-chief Dr. Jeffrey Drazen as saying, “It’s a subtle but very critical point.”

The study's authors said in a letter to the editor that an independent statistical analysis of the trial's cardiovascular data is under way. After the correction's online release Monday, Merck issued a statement saying it stood behind its contention that the increased risk occurred after 18 months of daily use.

(Readers should know that Physician's First Watch and the New England Journal of Medicine are both published by the Massachusetts Medical Society.)