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"Comparison of upper gastrointestinal
toxicity of rofecoxib and naproxen in patients with rheumatoid
arthritis," by Claire Bombardier
and 11 others, for the VIGOR study group, New England Journal of Medicine,
343(21):1520-8, 23 November 2000.
[Authors' affiliations: 15 institutions
worldwide]
Abstract: "Background
Each year, clinical upper gastrointestinal events occur in 2 to 4 percent of
patients who are taking nonselective nonsteroidal antiinflammatory drugs (NSAIDS).
We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2,
would be associated with a lower incidence of clinically important upper
gastrointestinal events than is the nonselective NSAID naproxen among patients
with rheumatoid arthritis. Methods We randomly assigned 8076
patients who were at least 50 years of age (or at least 40 years of age and
receiving long-term glucocorticoid therapy) and who had rheumatoid arthritis
to receive either 50 mg of rofecoxib daily and 500 mg of naproxen twice daily.
The primary end point was confirmed clinical upper gastrointestinal events (gastroduodenal
perforation or obstruction, upper gastrointestinal bleeding, and symptomatic
gastroduodenal ulcers). Results Rofecoxib and naproxen had a
similar efficacy against rheumatoid arthritis. During a median follow-up of
9.0 months, 2.1 confirmed gastrointestinal events per 100 patient-years
occurred with rofecoxib, as compared with 4.5 per 100 patient-years with
naproxen (relative risk, 0.5; 95 percent confidence interval, 0.3 to 0.6;
P<0.001). The respective rates of complicated confirmed events
(perforation, obstruction, and severe upper gastrointestinal bleeding) were
0.6 per 100 patient-years and 1.4 per 100 patient years (relative risk, 0.4;
95 percent confidence interval; 0.2 to 0.8; P=0.005). 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; 95 percent confidence interval, 0.1 to 0.7); the overall mortality
rate and the rate of death from cardiovascular causes were similar in the two
groups. Conclusions In patients with rheumatoid arthritis,
treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is
associated with significantly fewer clinically important upper
gastrointestinal events than treatment with naproxen, a nonselective
inhibitor."
This 2000 report from the New England
Journal of Medicine was cited 33 times in current journal
articles indexed in the ISI database during November-December 2001. Its tally
during that two-month period made this the second-most-cited paper in medicine
(not counting reviews) published in the last two years. Prior to the most
recent bimonthly count, citations to the paper have accrued as follows:
September-October 2001: 11 citations
July-August 2001: 9
May-June 2001: 12
March-April 2001: 2
Total citations to date: 67
SOURCE: Hot
Papers Database (Available from the ISI
Research Services Group in a CD-ROM version containing 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. Database is
combined with subscription to the ISI newsletter Science
Watch®; updated discs containing the
most recent bimonthly data are mailed with each new issue, six times a
year.)
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