[Comparative endoscopic study of gastroduodenal tolerance 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 tolerability 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 1) 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.
Müller
P
P
Krankenhaus Salem, Heidelberg.
Simon
B
B
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000633:toxicity*; D003505:Cyclodextrins / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D004386:Duodenum / Q000187:drug effects*; D016145:Endoscopy, Digestive System; D005753:Gastric Mucosa / Q000187:drug effects*; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects*; D008297:Male; D010894:Piroxicam / Q000633:toxicity*; D047392:beta-Cyclodextrins
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003505:Cyclodextrins; D004338:Drug Combinations; D047392:beta-Cyclodextrins; D010894:Piroxicam; C061072:piroxicam-beta-cyclodextrin
Vergleichende endoskopische Untersuchung zur gastroduodenalen Verträglichkeit von Piroxicam-beta-Cyclodextrin vs Piroxicam.