Efficacy and safety of rabeprazole in non-steroidal anti-inflammatory drug-induced ulcer in Japan.
OBJECTIVE
To investigate the efficacy and safety of rabeprazole under continuous non-steroidal anti-inflammatory drug (NSAID) administration for NSAID-induced ulcer in Japan.


METHODS
Subjects comprised patients undergoing NSAID treatment in whom upper gastrointestinal endoscopy revealed an ulcerous lesion (open ulcer) with diameter > or = 3 mm, who required continuous NSAID treatment. Endoscopies were performed at the start of treatment, during the treatment period, and at the conclusion (or discontinuation) of treatment. Findings were evaluated as size (maximum diameter) and stage based on the Sakita-Miwa classification. An ulcer was regarded as cured when the "white coating" was seen to have disappeared under endoscopy. As criteria for evaluating safety, all medically untoward symptoms and signs (adverse events, laboratory abnormalities, accidental symptoms, etc.) occurring after the start of rabeprazole treatment were handled as adverse events.


RESULTS
Endoscopic cure rate in 38 patients in the efficacy analysis (endoscopic evaluation) was 71.1% (27/38). Among those 38 patients, 35 had gastric ulcer with a cure rate of 71.4% (25/35), and 3 had duodenal ulcer with a cure rate of 66.7% (2/3). Three adverse drug reactions were reported from 64 patients in the safety analysis (interstitial pneumonia, low white blood cell count and pruritus); thus, the incidence rate for adverse drug reactions was 4.7% (3/64).


CONCLUSIONS
The treatment efficacy of rabeprazole for NSAID-induced ulcer under continuous NSAID administration was confirmed.
Gamagori City Hospital, 1-1 Mukaida, Hirata-Chou, Gamagori, Aichi 443-8501, Japan. mizokami-yuji@gamahp.jp
Yuji
Y
Mizokami
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000494:pharmacology*; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000494:pharmacology*; D004008:Diclofenac / Q000627:therapeutic use; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000453:epidemiology; D004724:Endoscopy / Q000379:methods; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010666:Phenylpropionates / Q000627:therapeutic use; D010894:Piroxicam / Q000031:analogs & derivatives / Q000627:therapeutic use; D064750:Rabeprazole; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000453:epidemiology
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000894:Anti-Inflammatory Agents, Non-Steroidal; D010666:Phenylpropionates; D010894:Piroxicam; D004008:Diclofenac; D064750:Rabeprazole; C040656:loxoprofen; C059451:lornoxicam