Is celecoxib (Celebrex) or naproxen (Naprosyn) with esomeprazole (Nexium) a better choice for managing arthritis pain in patients over 50 years of age with impaired gastrointestinal function?

From the Guidelines

For patients over 50 years of age with impaired gastrointestinal function, naproxen with esomeprazole is generally a better choice for managing arthritis pain than celecoxib. This recommendation is based on the most recent and highest quality evidence available, which suggests that the combination of naproxen and esomeprazole provides effective pain relief while minimizing the risk of gastrointestinal complications, which are common in older adults 1. The use of naproxen (typically 250-500 mg twice daily) combined with esomeprazole (20 mg once daily) is often more cost-effective than celecoxib (100-200 mg twice daily), a COX-2 selective NSAID, and may have a slightly more favorable cardiovascular profile 1. Some key points to consider when making this decision include:

• The risk of gastrointestinal complications, such as dyspepsia, abdominal pain, and GI bleeding, which can be reduced by combining NSAIDs with a proton pump inhibitor (PPI) like esomeprazole 1
• The risk of cardiovascular complications, such as worsening hypertension, myocardial infarction, and stroke, which can be associated with the use of NSAIDs, including celecoxib 1
• The importance of monitoring kidney function in older adults, as both naproxen and celecoxib can affect renal function 1
• The need to use the lowest effective dose for the shortest duration necessary to control symptoms, with regular reassessment of benefits versus risks 1. Overall, the decision to use naproxen with esomeprazole or celecoxib should be based on individual patient factors, including their history of cardiovascular disease, gastrointestinal risk, and renal function, as well as their overall health status and medical history 1.

From the FDA Drug Label

The cumulative rates in all patients at nine months for celecoxib capsules, diclofenac, and ibuprofen were 1.2%, 1.4%, and 1.1%, respectively. In the endoscopic studies, approximately 11% of patients were taking aspirin (≤ 325 mg/day). In a clinical trial comparing standard formulations of naproxen 375 mg bid (750 mg a day) vs 750 mg bid (1500 mg/day), 9 patients in the 750 mg group terminated prematurely because of adverse events. The incidence of endoscopic ulcers was studied in two 12-week, placebo-controlled studies in 2157 OA and RA patients in whom baseline endoscopies revealed no ulcers. There was no dose relationship for the incidence of gastroduodenal ulcers and the dose of celecoxib capsules (50 mg to 400 mg twice daily). The incidence for naproxen 500 mg twice daily was 16.2% and 17.6% in the two studies, for placebo was 2.0% and 2.3%, and for all doses of celecoxib capsules the incidence ranged between 2.7% to 5.9% 2.

Key Considerations:

• The use of celecoxib with esomeprazole may be beneficial for patients with impaired gastrointestinal function due to its lower incidence of endoscopic ulcers compared to naproxen.
• The incidence of endoscopic ulcers with celecoxib was between 2.7% to 5.9%, whereas naproxen had an incidence of 16.2% and 17.6% in two studies.
• However, the FDA label does not directly compare the combination of celecoxib or naproxen with esomeprazole for managing arthritis pain in patients over 50 years of age with impaired gastrointestinal function.

Answer: Based on the available data, celecoxib with esomeprazole may be a better choice for managing arthritis pain in patients over 50 years of age with impaired gastrointestinal function due to its lower incidence of endoscopic ulcers compared to naproxen 2. However, this decision should be made with caution and consideration of individual patient factors, as the FDA label does not directly address this specific question.

From the Research

Comparison of Celecoxib and Naproxen with Esomeprazole

• Celecoxib is a cyclo-oxygenase (COX) inhibitor that exhibits relative in vitro and ex vivo selectivity for COX-2 over COX-1, making it a safer option for patients with impaired gastrointestinal function 3.
• A fixed-dose combination of naproxen and esomeprazole magnesium has comparable upper gastrointestinal tolerability to celecoxib in patients with osteoarthritis of the knee 4.
• Celecoxib has been shown to be superior to placebo and equivalent to traditional non-steroidal anti-inflammatory drugs (tNSAIDs) in terms of efficacy, with a good gastrointestinal tolerability profile 5.

Efficacy and Safety in Patients over 50 years of Age

• Celecoxib is effective in treating osteoarthritis and rheumatoid arthritis in patients over 50 years of age, with a lower incidence of upper gastrointestinal ulceration and complications compared to traditional NSAIDs 3, 5.
• The combination of naproxen and esomeprazole magnesium is also effective in treating osteoarthritis, with a comparable safety profile to celecoxib in patients over 50 years of age 4, 6.
• Long-term treatment with the fixed-dose combination of naproxen and esomeprazole magnesium is not associated with any new safety issues, including predefined upper gastrointestinal and cardiovascular adverse events, in patients requiring NSAID therapy who are at risk of upper gastrointestinal complications 6.

Considerations for Impaired Gastrointestinal Function

• Celecoxib may be a better option for patients with impaired gastrointestinal function due to its selective inhibition of COX-2, which reduces the risk of gastrointestinal complications 3, 7.
• The combination of naproxen and esomeprazole magnesium may also be a suitable option for patients with impaired gastrointestinal function, as esomeprazole provides gastroprotection and reduces the risk of upper gastrointestinal adverse events 4, 6.