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Celecoxib use results in fewer GI events than nonselective NSAIDs
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Patients taking celecoxib were at a lower risk for developing clinically significant gastrointestinal events than patients using nonselective nonsteroidal anti-inflammatory drugs in a recent study.
In the multicenter, prospective, masked endpoint GI Randomized Event and Safety Open-Label NSAID Study (GI-REASONS), researchers randomly assigned 8,067 patients aged 55 years or older taking nonsteroidal anti-inflammatory drugs (NSAID) daily for osteoarthritis to receive either COX-2-selective NSAID celecoxib (n=4,035) or nonselective NSAID (nsNSAID; n=4,032) for 6 months.
Byron Cryer
“Although randomized, clinical trials have several desirable qualities, their major criticism is that their patients and management algorithms are so narrowly focused that results seen in the randomized clinical trial may not be generalizable to actual practice,” researcher Byron Cryer, MD, professor of medicine at University of Texas Southwestern Medical School, told Healio.com. “In GI-REASONS, we simulated a ‘real-world’ environment, in that the patients’ inclusion criteria were broadened and investigators had broader discretion to reflect types of patients and a management style, which is more reflective of actual clinical practice.”
GI events occurred significantly more frequently among patients using nsNSAID (2.4% vs. 1.3% among celecoxib recipients), while other adverse events occurred at a similar rate between the groups. Investigators calculated an OR of 1.82 (95% CI, 1.31-2.55) for GI events among nsNSAID recipients. In sensitivity analyses, attributing GI events to all patients lost to follow-up (2.1% of the celecoxib group and 2.6% of nsNSAID recipients, OR=1.46; 95% CI, 1.18-1.82) and excluding patients who deviated from protocol (OR=2.51; 95% CI, 1.35-4.65) did not eliminate the significance of the association between GI events and nsNSAID use.
Abdominal symptoms were considered moderate-to-severe in 3.4% of nsNSAID patients, compared with 2.3% celecoxib recipients (P=.0035). nsNSAID recipients also experienced a larger decrease in hemoglobin from baseline (P<.00001), with more patients experiencing a decrease of 2 g or more or a 10% or greater decrease in hematocrit (2.9% vs. 1.8%, P=.0023). Adverse and serious adverse events occurred similarly between groups.
“GI-REASONS provides valuable GI safety data relevant to clinical practice,” the researchers concluded. “A greater understanding of NSAID risk throughout the entire GI tract should lead to more effective patient management and identification of improved risk-reduction strategies.”
Disclosure: See the study for a full list of relevant disclosures.
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