(Ivanhoe Newswire) -- A large prospective trial assessing whether the
anti-inflammatory drug Vioxx (rofecoxib) could prevent cancer recurrence in
colon cancer patients shows that Vioxx nearly doubled the risk of stroke and
heart attack in patients receiving the drug vs. those who took a placebo.
The safety-monitoring board of the Vioxx trial first noticed this risk and
reported it last September, which halted the study. Vioxx was then pulled from
the United States market.
Lead study author Robert S. Bresalier, M.D., of the University of Texas M.D.
Anderson Cancer Center in Houston and colleagues note 46 of the 1,287 patients
who had taken Vioxx in the drug trial had cardiovascular events, mainly heart
attacks or strokes, within three years. Among the placebo group, 26 of the 1,299
patients had cardiovascular events. Each group had the same number of deaths,
not all related to stroke or heart attack.
Dr. Bresalier adds that while the number of heart attack and stroke incidents
in the group receiving Vioxx was small, "the difference between the groups is
significant." He also points out that patients who took Vioxx did not begin
having cardiovascular problems such as heart attack or stroke until 18 months of
treatment.
Other cardiovascular problems such as pulmonary edema, hypertension, and
heart failure occurred earlier and appeared more prevalent in the group taking
Vioxx. However, data showing a correlation between Vioxx and these milder
cardiovascular problems is not as solid, according to the study authors.
SOURCE: The New England Journal of Medicine, published online Feb.
15, 2005
