Endoscopic study comparing gastroduodenal tolerability of piroxicam-beta-cyclodextrin vs. piroxicam

The gastroduodenal tolerability of piroxicam-beta-cyclodextrine was evaluated in a double-blind, parallel group, study in 32 healthy male volunteers. The doses used were 20 mg piroxicam-beta-cyclodextrin vs 20 mg piroxicam daily over a period of 14 days. Gastric torerability was assessed by using upper endoscopy. Gastroscopy was performed at base-line and after the dosing period of 14 days. The mucosal lesions were scored using modified Lanza criteria. In comparison to piroxicam, piroxicam-beta-cyclodextrine was significantly better tolerated after a 14 day dosing period. Mean gastric-duodenal score: Piroxicam-beta-cyclodextrine 3+/-4 (median 1), piroxicam 6+/-4 (median 8). The score values for the stomach were for piroxicam-beta-cyclodextrin 2+/-3 (median I) and for piroxicam 4+/-3 (median 6). The corresponding values for the duodenal bulb 2+/-4 (median 0) and 4+/-5 (median 0), respectively. Both drugs averaged were generally well tolerated. In summary piroxicam-beta-cyclodextrin given as a 20 mg single oral morning-dose over a 14-day period was significantly better tolerated than piroxicam 20 mg with regard to gastroduodenal damage.