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AB0986 Pooled safety data from elderly arthritis patients in 21 clinical trials
  1. M. Noyes Essex,
  2. R. Zhang,
  3. S.R. Mallen
  1. Pfizer Inc, New York, United States

Abstract

Background Approximately one half of adults aged ≥65 years in the United States report having doctor-diagnosed arthritis. Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used by the elderly to manage arthritis pain. While these drugs are effective, the risk-benefit profile needs to be individualized for each patient. Data are needed for the elderly population.

Objectives The objective of this pooled analysis was to compare the adverse event (AE) profile of the cyclooxygenase-2 selective NSAID celecoxib and nonselective NSAIDs as reported by elderly patients with arthritis aged ≥65 years.

Methods This was an age-defined subgroup analysis of safety data in patients aged ≥65 years with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis from 21 randomized, parallel-group trials. Selected trials had a duration of ≥2 weeks and at least 1 celecoxib 200-400 mg/d and 1 nonselective NSAID (naproxen, ibuprofen, or diclofenac) arm at prescription doses. The analysis included all reported AEs, including gastrointestinal, cardiovascular, and hepatic AEs.

Results A total of 9461 patients aged ≥65 years at the time of study enrollment were categorized into celecoxib 200 mg total daily dose (TDD) (n=3287), 400 mg TDD (n=2585), naproxen (n=1104), ibuprofen (n=151), and diclofenac (n=2334) groups. Overall, AEs were less frequently reported in the celecoxib groups (44.8% 200 mg TDD, 46.1% 400 mg TDD) than in the nonselective NSAID groups (naproxen 58.6%, ibuprofen 62.9%, diclofenac 48.8%). Most frequently reported AEs were related to the digestive system, with fewer being reported by celecoxib-treated patients (19.4% 200 mg TDD, 21.0% 400 mg TDD) than by those receiving naproxen (33.6%), ibuprofen (30.5%), and diclofenac (24.2%). Cardiovascular AEs were rarely reported in all groups (<1%). Hepatic AEs were more commonly reported in the diclofenac group (3.8%; all other groups ≤1%). Central and peripheral nervous system AEs were most common in the ibuprofen group (17.9%; other groups ranged from 8.2%–11.1%); headache was reported by 11.9% of the ibuprofen group (other groups ranged from 3.6%–6.8%). Anemia was most common in the ibuprofen group (5.3%, other groups ranged from 0.7%–1.8%), as was ecchymosis (2.6% for ibuprofen, other groups ranged from 0.2%–0.8%).

Conclusions The overall incidence of AEs in this pooled analysis of elderly arthritis patients was lower in celecoxib-treated patients than in patients treated with naproxen, ibuprofen, and diclofenac. The results of this analysis should be taken into account when treating elderly patients with arthritis.

Disclosure of Interest M. Noyes Essex Employee of: Pfizer Inc, R. Zhang Employee of: Pfizer Inc, S. Mallen Employee of: Pfizer Inc

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