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"Cardiovascular risk associated with
celecoxib in a clinical trial for colorectal adenoma prevention,"
by
Scott D. Solomon and 9 others, for the Adenoma Prevention with Celecoxib (APC)
Study Investigators, New England Journal of Medicine, 352(11): 1071-80,
17 March 2005.
[Authors' affiliations: Brigham and Women's
Hospital, Harvard Medical School, Boston, MA; University of Glasgow, U.K.;
Statistics Collaborative, Washington, D.C.; National Cancer Institute,
Bethesda, MD; Memorial Sloan-Kettering Cancer Center, New York, NY]
Abstract:
"BACKGROUND Selective cyclooxygenase-2 (COX-2) inhibitors have
come under scrutiny because of reports suggesting an increased cardiovascular
risk associated with their use. Experimental research suggesting that these
drugs may contribute to a prothrombotic state provides support for this
concern. METHODS We reviewed all potentially serious cardiovascular
events among 2035 patients with a history of colorectal neoplasia who were
enrolled in a trial comparing two doses of celecoxib (200 mg or 400 mg twice
daily) with placebo for the prevention of colorectal adenomas. All deaths were
categorized as cardiovascular or noncardiovascular, and nonfatal
cardiovascular events were categorized in a blinded fashion according to a
prespecified scheme. RESULTS For all patients except those who died,
2.8 to 3.1 years of follow-up data were available. A composite cardiovascular
end point of death from cardiovascular causes, myocardial infarction, stroke,
or heart failure was reached in 7 of 679 patients in the placebo group (1.0
percent), as compared with 16 of 685 patients receiving 200 mg of celecoxib
twice daily (2.3 percent; hazard ratio, 2.3; 95 percent confidence interval,
0.9 to 5.5) and with 23 of 671 patients receiving 400 mg of celecoxib twice
daily (3.4 percent; hazard ratio, 3.4; 95 percent confidence interval, 1.4 to
7.8). Similar trends were observed for other composite end points. On the
basis of these observations, the data and safety monitoring board recommended
early discontinuation of the study drug. CONCLUSIONS Celecoxib use was
associated with a dose-related increase in the composite end point of death
from cardiovascular causes, myocardial infarction, stroke, or heart failure.
In light of recent reports of cardiovascular harm associated with treatment
with other agents in this class, these data provide further evidence that the
use of COX-2 inhibitors may increase the risk of serious cardiovascular
events."
This 2005 report from the New England
Journal of Medicine was cited 52 times in current journal
articles indexed by Thomson Scientific during July-August 2006. Thanks to that
two-month total, this is currently the second-most-cited paper in medicine
published in the last two years, aside from reviews. Prior to the most recent
bimonthly count, citations to the paper have accrued as follows:
May-June 2006: 39 citations
March-April 2006: 36
January-February 2006: 30
November-December 2005: 25
September-October 2005: 34
July-August 2005: 21
May-June 2005: 12
March-April 2005: 7
Total citations to date: 256
SOURCE: Hot
Papers Database (Included with a subscription to the print newsletter Science
Watch®, available from the
Research Services Group. Packaged on a CD that is mailed with each Science
Watch issue, the Hot
Papers Database contains data on hundreds of highly cited papers published
during the last two years. User interface permits searching by author,
organization, journal, field, and more. Total citations, as well as citations
accrued during successive bimonthly periods, can be assessed and graphed. An
updated CD containing the most recent bimonthly data is mailed with every new
issue of Science
Watch,
six times a year. The CD also includes an electronic version of the Science
Watch
issue in HTML format, for personal desktop access 
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