FL Lanza, et al. - Authors assessed the upper gastrointestinal (GI) impacts of over-the-counter doses of 2 fast-dissolving (FD) ibuprofen products and 1 FD-N-acetyl-p-­aminophenol (APAP) product. An association of the treatment with 2 ibuprofen products with significant gastric mucosal injury was noted. The highest risk of incidence of gastroduodenal mucosal injury was seen with FD ibuprofen liquid capsules, out of the 4 treatments studied. NO clinically or statistically significant gastroduodenal mucosal injury was seen from the treatment with FD-APAP.

Methods

• Twenty-eight healthy subjects received FD ibuprofen 2×200 mg liquid capsules 3 times daily (TID), ibuprofen 2×200 mg tablets TID, FD-APAP 2×500 mg tablets 4 times daily (QID), and placebo 2×500 mg tablets QID for 7 days, in a randomized, placebo-controlled, endoscopist-blinded, 4-way crossover study.
• Gastric mucosal damage assessed by endoscopy using the Lanza scale: 0=normal stomach or proximal duodenum, 1=mucosal hemorrhages only, 2=1 or 2 erosions, 3=numerous (3–10) erosions, and 4=large number of erosions (>10) or ulcer was the primary end point.
• Experts noted the secondary end points to include duodenal mucosal damage (Lanza scale); gastroduodenal mucosal injury, classified as present (gastric and/or duodenal endoscopy score ≥2) or absent (gastric and/or duodenal endoscopy score <2); and number of hemorrhages, erosions, and ulcers counted separately in the stomach and duodenum.

Results

• Findings suggested that significantly greater gastric mucosal injury was observed after treatment with both ibuprofen products vs FD-APAP (p < 0.0001 and p=0.0095, respectively).
• As per data, FD-APAP demonstrated no difference from placebo (p= .4794).
• Researchers found the odds of having an incidence of gastroduodenal mucosal injury to be over 6 times greater from FD ibuprofen liquid capsule treatment (odds ratio [OR]=6.19, 95% confidence interval [CI]: 1.60, 23.97) and over 3 times greater from ibuprofen tablet treatment (OR=3.19, 95% CI: 0.8, 12.74) vs FD-APAP.