Clinical trial: comparison of the gastrointestinal safety of lumiracoxib with traditional nonselective nonsteroidal anti-inflammatory drugs early after the initiation of treatment--findings from the Therapeutic Arthritis Research and Gastrointestinal Event Trial.
BACKGROUND
The large (n = 18 325) Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) study demonstrated a significant gastrointestinal benefit with lumiracoxib 400 mg o.d. (4x the recommended dose in osteoarthritis) vs. naproxen 500 mg b.d. or ibuprofen 800 mg t.d.s.


OBJECTIVE
To investigate how early a reduction in ulcer complications could be detected with lumiracoxib vs. nonselective nonsteroidal anti-inflammatory drugs in TARGET.


METHODS
Pointwise 95% confidence intervals were generated for the between-treatment differences in Kaplan-Meier estimates for definite or probable upper gastrointestinal ulcer complications (ulcer complications) and for all ulcers.


RESULTS
In patients not on aspirin, there was a significant reduction in all ulcers by day 8 and in ulcer complications by day 16 with lumiracoxib compared with both nonselective nonsteroidal anti-inflammatory drugs combined, by day 6 (all ulcers) and day 14 (ulcer complications) vs. naproxen and by day 32 (all ulcers) and day 33 (ulcer complications) vs. ibuprofen.


CONCLUSIONS
Even with short-term use, there are gastrointestinal safety benefits for lumiracoxib vs. nonselective nonsteroidal anti-inflammatory drugs.
Hawkey
C J
CJ
Wolfson Digestive Diseases Centre, University Hospital Nottingham, Nottingham, UK. cj.hawkey@nottingham.ac.uk
Weinstein
W M
WM
Stricker
K
K
Murphy
V
V
Richard
D
D
Krammer
G
G
Rebuli
R
R
D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001168:Arthritis / Q000188:drug therapy*; D001241:Aspirin / Q000009:adverse effects; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004008:Diclofenac / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects; D013223:Statistics as Topic
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D004008:Diclofenac; D009288:Naproxen; D001241:Aspirin; C473384:lumiracoxib; D007052:Ibuprofen