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.

Abstract

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.

AIM:

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.

CONCLUSION:

Even with short-term use, there are gastrointestinal safety benefits for lumiracoxib vs. nonselective nonsteroidal anti-inflammatory drugs.

• Authors: C J Hawkey, W M Weinstein, K Stricker, V Murphy, D Richard, G Krammer, R Rebuli
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 27 Issue 9 Pg. 838-45 (May 2008) ISSN: 1365-2036 [Electronic] England
• PMID: 18221410 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Cyclooxygenase 2 Inhibitors
• Diclofenac
• Naproxen
• Aspirin
• lumiracoxib
• Ibuprofen

Topics

• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects)
• Arthritis (drug therapy)
• Aspirin (adverse effects)
• Cyclooxygenase 2 Inhibitors (therapeutic use)
• Diclofenac (adverse effects, analogs & derivatives)
• Female
• Gastrointestinal Diseases (drug therapy)
• Humans
• Ibuprofen (adverse effects)
• Male
• Middle Aged
• Naproxen (adverse effects)
• Statistics as Topic