Placebo-controlled comparison of piroxicam-?-cyclodextrin, piroxicam, and indomethacin on gastric potential difference and mucosal injury in humans

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Abstract
The acute gastroduodenal mucosa injury and gastric potential difference (GPD) drops provoked by 14-day administration of 20 mg/day of a new piroxicam formulation (piroxicam-β-cyclodextrin), 20 mg/day standard piroxicam and 100 mg/day indomethacin were evaluated and compared in a randomized, double-blind, placebo-controlled study carried out on 64 volunteers. Endoscopic examinations, performed after 14-day treatment, demonstrated that piroxicam-β-cyclodextrin was less gastrolesive (mean endoscopic score±SE=0.56±0.2) than either piroxicam (2.06±0.5) or indomethacin (2.25 ±0.5) (pp<0.01), which registered similar values to placebo. Since GPD is an expression of the anatomo-functional integrity of the gastric barrier, the results indicate that piroxicam-β-cyclodextrin exerts less direct acute damage on the gastric mucosa. Therefore, when administered short-term, piroxicam-β-cyclodextrin appears to be less gastrolesive than either indomethacin or the standard piroxicam formulation.