Background/Purpose: Celecoxib use was associated with a lower risk of clinically relevant upper and lower GI events than nonselective (ns)NSAIDs in patients (≥ 55 years) with osteoarthritis (OA) at moderate GI risk, in standard US clinical practice, in the GI Randomized Event and Safety Open-Label NSAID Study (GI-REASONS).¹Age has been identified as a factor for increasing patient risk for a GI adverse event when using NSAIDs. The objective was to assess whether the observed decreased GI risk with celecoxib compared to nsNSAIDs varies with advancing age in 8067 patients from the GI-REASONS trial.

Methods: A post hoc analysis of a prospective, randomized, open-label, blinded end point study¹ where patients were randomized (1:1) and stratified by H pylori status to receive celecoxib or any nsNSAID for 6 months. Patients randomized to the nsNSAID arm could switch between nsNSAIDS; crossover between treatment arms was not allowed. The primary end point, a composite of investigator and blinded adjudicated clinically significant upper and lower GI events, was assessed according to age (< 60 years, 60-69 years, and ≥ 70 years). Analyses were performed on the intention-to-treat (ITT) population controlling for H pyloristatus.

Results: 4035 celecoxib and 4032 nsNSAID patients with OA were included in the ITT population. 1344 (33.3%) and 1363 (33.8%) were aged < 60 years, 1997 (49.5%) and 1949 (48.3%) were aged 60-69 years, and 688 (17.1%) and 714 (17.7%) were aged ≥ 70 years in the celecoxib and nsNSAID groups, respectively. Age was not specified in 6 patients in both treatment groups. Significantly more patients aged < 60 years and ≥ 70 years in the nsNSAIDs group than in the celecoxib group met the primary end point at 6 months (Table 1). Consistent with the primary results, the most commonly used nsNSAID in each age group was meloxicam. The number of patients using gastric protective agents in the celecoxib and nsNSAID groups were 310 (25.5%) and 335 (27.4%) aged < 60 years, 525 (28.4%) and 517 (28.5%) aged 60-69 years, and 169 (25.8%) and 223 (32.7%) aged ≥ 70 years, respectively. The number of patients who experienced moderate to severe abdominal symptoms in the celecoxib and nsNSAID groups were 37 (2.8%) and 49 (3.6%) aged < 60 years, 40 (2%) and 72 (3.7%) aged 60-69 years, and 17 (2.5%) and 17 (2.4%) aged ≥ 70 years, respectively.

Conclusion: Celecoxib use had a lower risk of clinically significant upper and lower GI events than nsNSAIDs in patients < 60 and ≥ 70 years in the GI-REASONS trial. These data should be considered when prescribing NSAIDs for patients with OA.

Table 1. Clinically Significant Upper and Lower GI Events

	Celecoxib		nsNSAID		OR (95% CI)	P Value
	N	Patients With Event n (%)	N	Patients With Event n (%)
< 60 years	1344	13 (1.0)	1363	30 (2.2)	2.3 (1.2-4.3)	0.0120
60-69 years	1997	35 (1.8)	1949	47 (2.4)	1.4 (0.9-2.1)	0.1570
≥ 70 years	688	6 (0.9)	714	21 (2.9)	3.7 (1.5-9.2)	0.0035

Reference: 1. Cryer B, et al. Arthritis Rheum. 2011;63:S777.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effect-of-advancing-age-on-the-gastrointestinal-safety-of-celecoxib-versus-nonselective-nonsteroidal-anti-inflammatory-drugs-a-post-hoc-analysis-of-gi-reasons/