A randomised, double-blind study comparing lumiracoxib with naproxen for acute musculoskeletal pain.
BACKGROUND
Some selective cyclooxygenase-2 (COX-2) inhibitors have been shown to provide analgesic efficacy in patients with acute pain.


OBJECTIVE
To compare the efficacy and safety of the COX-2 inhibitor lumiracoxib 400 mg once daily (qd) and naproxen 500 mg twice daily (bid) in patients with acute musculoskeletal pain caused by uncomplicated soft tissue injury.


METHODS
This was a randomised, double-blind, parallel-group, non-inferiority study set in 39 primary care centres in the UK. Patients were randomised to lumiracoxib 400 mg qd or naproxen 500 mg bid and took the study medication for as long as they felt that it was needed, up to day 7. The primary efficacy analysis was the sum of the pain intensity difference (0-100 mm visual analogue scale) determined morning and evening over the first 5 days of treatment (SPID-5).


RESULTS
The intention-to-treat population comprised 406 patients [lumiracoxib 400 mg qd (n = 207); naproxen 500 mg bid (n = 199)]. Both treatments were effective in reducing pain intensity over 5 days. The mean SPID-5 scores were 117.0 mm.day for lumiracoxib and 118.2 mm.day for naproxen [the treatment difference based on adjusted means from the ANCOVA was -2.78 mm.day, 95% confidence interval (CI) -17.4, 11.9]. The lower margin of the 95% CI was above the predetermined non-inferiority margin (-50 mm.day) for SPID-5, indicating non-inferiority of lumiracoxib compared with naproxen. Both treatments were well tolerated.


CONCLUSIONS
Lumiracoxib 400 mg qd is as effective as naproxen 500 mg bid for the management of moderate-to-severe acute musculoskeletal pain.
Kyle
C
C
Glengormley Practice, Belfast, Northern Ireland, UK.
Zachariah
J
J
Kinch
H
H
Ellis
G
G
Andrews
C
C
Adekunle
F
F
D000208:Acute Disease; D000328:Adult; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009140:Musculoskeletal Diseases / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage* / Q000009:adverse effects; D010146:Pain / Q000188:drug therapy*; D016896:Treatment Outcome
D052246:Cyclooxygenase 2 Inhibitors; D004008:Diclofenac; D009288:Naproxen; C473384:lumiracoxib