Efficacy and Safety of the Selective Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Rheumatoid Arthritis and Osteoarthritis in Japan

Abstract

Background/Aims: Gastrointestinal (GI) disorders are common adverse reactions of nonsteroidal anti-inflammatory drugs (NSAIDs). Loxoprofen is a representative NSAID widely used in East Asia. A selective cyclooxygenase-2 inhibitor, celecoxib, was introduced in Japan in 2007. In this study, we aimed to compare the efficacy and safety of celecoxib with those of loxoprofen in Japanese patients. Methods: We analyzed the data from 12 clinical studies conducted in Japan. These data of Japanese patients were compared with those of the patients in the West that had been published after 2000. Results: The efficacy of celecoxib as an analgesic was comparable to that of loxoprofen, whereas serious GI events, including symptomatic ulcers, were significantly less frequent with celecoxib than with loxoprofen in Japanese patients with rheumatoid arthritis (RA) and osteoarthritis (OA) (p = 0.039). These results were consistent with the findings of the studies conducted in the West. The incidence of serious cardiovascular events was 0.1% in 2,398 subjects on celecoxib, which was not statistically different from the incidence in subjects on loxoprofen (0.3%; p = 0.3404) and those on placebo (0.2%); this result was also consistent with the data of the studies conducted in the West. Conclusion: The analgesic activity of celecoxib, which was used for the treatment of RA, OA, and low back pain, was comparable to that of loxoprofen, and celecoxib was safer in terms of GI injury often caused by other nonselective NSAIDs.

Small bowel injury induced by selective cyclooxygenase-2 inhibitors: a prospective, double-blind, randomized clinical trial comparing celecoxib and meloxicam

“…All remaining subjects were then randomized, by a computer-generated randomization system, to receive either celecoxib (200 mg twice daily) or meloxicam (10 mg once daily) for 2 weeks. The dose of each drug was determined on the basis of the dose approved by the Japanese Ministry of Health and Welfare and applied to other clinical trials [24,25]. In both groups, omeprazole (20 mg once daily) was given in consideration of possible gastric mucosal injury.…”

“…In the meloxicam group, two subjects experienced abdominal discomfort and one subject had diarrhea. As shown in Table 2, the GSRS score was 17 (range [15][16][17][18][19][20][21][22][23][24][25] in the celecoxib group and 18 (range [15][16][17][18][19][20][21][22][23][24][25][26] in the meloxicam group. None of the subjects manifested anemia at the end of the medication period.…”

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

“…An analysis of 12 studies that compared celecoxib with loxoprofen in Japanese patients with OA or rheumatoid arthritis (RA) showed that there were significantly fewer serious GI events, including symptomatic ulcers, with celecoxib ( P  <   0.05) 20. An analysis of three 12‐week studies that compared twice‐daily celecoxib with diclofenac in Chinese patients with OA or RA showed that there was no statistical difference in occurrence of gastroduodenal ulcers (primary outcome) (2.8% vs .…”

Analgesic efficacy of celecoxib in patients after oral surgery: special reference to time to onset of analgesia and duration of analgesic effect

“…Therefore, COX-2 selective inhibitors have been developed as NSAIDs with fewer adverse effects and applied in the clinical setting. Celecoxib is a typical COX-2 inhibitor and several studies have reported that it causes fewer adverse effects such as gastrointestinal disorders or renal disorders compared with conventional non-selective COX inhibitors such as ibuprofen, loxoprofen, naproxen, or diclofenac [5][6][7][8][9][10]. Celecoxib was approved and came to market in the USA in 1999 with indications and usage for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute pain, and primary dysmenorrhea.…”