An editorial, published in The New England Journal of Medicine ( NEJM ), has informed regarding inaccuracies in data in the report of the VIGOR ( Vioxx Gastrointestinal Outcomes Research ) study by Bombardier et al..

The VIGOR study was designed primarily to compare gastrointestinal events in patients with rheumatoid arthritis randomly assigned to the treatment with Rofecoxib ( Vioxx ) or Naproxen ( Naprosyn ).
Data on cardiovascular events were also monitored.

NEJM editors have now uncovered that three myocardial infarctions, all in the Vioxx group, were not included in the data submitted to the Journal.

The editors first became aware of the additional myocardial infarctions in 2001 when updated data were made public by the Food and Drug Administration ( FDA ).
Until the end of November 2005, editors believed that these were late events that were not known to the authors in time to be included in the article published in the Journal on November 23, 2000.

“ Lack of inclusion of the three events resulted in an understatement of the difference in risk of myocardial infarction between the Rofecoxib and Naproxen groups, “ editors write.

VIGOR study investigators concluded that the incidence of myocardial infarction was lower among patients in the Naproxen group than among those in the Rofecoxib group ( 0.1 percent vs. 0.4 percent; relative risk, 0.2 ).

“ The difference in the rates of myocardial infarction between the Rofecoxib and Naproxen groups was not significant among the patients without indications for Aspirin therapy as secondary prophylaxis.

“ Naproxen inhibits the production of thromboxane by 95 percent and inhibits platelet aggregation by 88 percent, and this effect is maintained throughout the dosing interval; therefore, the effects of regular use of Naproxen may be similar to those of Aspirin, “ VIGOR investigators wrote.

In the article, published in 2000, VIGOR investigators presented the data as a reduction in the risk of myocardial infarction with Naproxen, while new data shows an increase in the risk with Rofecoxib.

One of the study's authors was Alise Reicin, Merck's vice president for clinical research.

Source: The New England Journal of Medicine, 2005


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