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"Gastrointestinal toxicity with
celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and
rheumatoid arthritis. The CLASS Study: a randomized controlled trial,"
by Fred E. Silverstein and 16 others, JAMA-Journal of the American Medical
Association, 284(10):1247-55, 13 September 2000.
[Authors' affiliations: 10 U.S. institutions]
Abstract: "Context
Conventional nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with
a spectrum of toxic effects, notably gastrointestinal (GI) effects, because of
inhibition of cyclooxygenase (COX)-1. Whether COX-2-specific inhibitors are
associated with fewer clinical G1 toxi effects is unknown. Objective To
determine whether celecoxib, a COX-2-specific inhibitor, is associated with a
lower incidence of significant upper GI toxic effects and other adverse
effects compared with conventional NSAIDs. Design The Celecoxib
Long-term Arthritis Safety Study (CLASS) a double-blind randomized controlled
trial conducted from September 1998 to March 2000. Setting Three
hundred eighty six clinical sites in the United States and Canada. Participants
A total of 8059 patients (greater than or equal to 18 years old) with
osteoarthritis (OA) or rheumatoid arthritis (RA) were enrolled in the study,
and 7968 received at least 1 dose of study drug. A total of 4573 patients
(57%) received treatment for 6 months. Interventions Patients were
randomly assigned to receive celecoxib, 400 mg twice per day (2 and 4 times
the maximum RA and OA dosages, respectively; n=3987); ibuprofen, 800 mg 3
times per day (n=1985); or diclofenac, 75 mg twice per day (n=1996). Aspirin
use for cardiovascular prophylaxis (less than or equal to 325 mg/d) was
permitted. Main Outcome Measures Incidence of prospectively defined
symptomatic upper GI ulcers and ulcer complications (bleeding, perforation,
and obstruction) and other adverse effects during the 6-month treatment
period. Results For all patients, the annualized incidence rates of
upper GI ulcer complications alone and combined with symptomatic ulcers for
celecoxib vs NSIADs were 0.76% vs 1.45% (P=.02), respectively. For patients
not taking aspirin, the annualized incidence rates of upper GI ulcer
complications alone and combined with symptomatic ulcers for celecoxib vs
NSAIDs were 0.44% vs 1.27% (P=.04) and 1.40% vs 2.91% (P=.02). For patients
taking aspirin, the annualized incidence rates of upper GI ulcer complications
alone and combined with symptomatic ulcers for celecoxib vs NSAIDs were 2.01%
vs 2.12% (P=.92) and 4.70% vs 6.00% (P=.49). Fewer celecoxib-treated patients
than NSAID-treated patients experienced chronic GI blood loss, GI intolerance,
heptatoxicity, or renal toxicity. No difference was noted in the incidence of
cardiovascular events between celecoxib and NSAIDs, irrespective of aspirin
use. Conclusions In this study, celecoxib, at dosages greater than
those indicated clinically, was associated with a lower incidence of
symptomatic ulcers and ulcer complications combined, as well as other
clinically important toxic effects, compared with NSAIDs at standard dosages.
The decrease in upper GI toxicity was strongest among patients not taking
aspirin concomitantly."
This 2000 report in JAMA was cited 49
times in current journal articles indexed in the ISI database during
November-December 2001. That two-month total made it the second-most-cited
paper in medicine, aside from 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: 22 citations
July-August 2001: 15
May-June 2001: 19
March-April 2001: 16
January-February 2001: 6
November-December 2000: 3
September-October 2000: 1
Total citations to date: 131
SOURCE: Hot
Papers Database (Included with a subscription to the ISI print newsletter Science
Watch®, available from the ISI
Research Services Group. Packaged on a CD-ROM 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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