Evaluation of omeprazole as a treatment for gastric and prepyloric ulcer in Korean patients.
The healing efficacy of omeprazole was assessed in 57 Korean patients with endoscopically-proven gastric (GU) and/or prepyloric (PPU) ulcers of at least 5 mm diameter. Fifty-three patients presented with GU, two with PPU and two with both types of ulcer. The maximum ulcer diameter was 5-10 mm in 27 patients and greater than 10 mm in 30 patients. All patients received 20 mg of omeprazole each morning for 4-8 weeks depending on ulcer healing. Ulcer healing rates were comparable using both 'intention to treat' (IT) and 'per protocol' (PP) analyses. Following the IT approach 82% (47 of 57) of patients were healed at 4 weeks and 98% (56 of 57) at 8 weeks. Following the PP approach, the corresponding healing rates were 83% (44 of 53) and 98% (55 of 56), respectively. Smoking was found to have a significant effect on ulcer healing at 4 weeks (P = 0.03), with 96% (26 of 27) of non/occasional smokers healed versus only 69% (18 of 26) of daily/heavy smokers. Ulcer size did not have a significant effect on healing, however. Ulcer symptoms, reported by all patients at entry, disappeared rapidly after commencement of omeprazole therapy. Only four patients reported mild symptoms at 4 weeks and no symptoms were reported at 8 weeks. No clinically significant changes in haematology or clinical chemistry (other than a rise in leucocytes in one patient) and no serious adverse events were observed. In conclusion, omeprazole 20 mg each morning was found to be safe and highly effective for treatment of gastric and prepyloric ulcer in Korean patients, producing a 98% healing rate. Symptom relief was rapid and the drug was well tolerated.
Sun
H S
HS
Catholic University, Seoul, Korea.
Choi
K W
KW
Yoon
C M
CM
Park
K N
KN
Min
Y I
YI
Lee
S I
SI
Chung
J M
JM
Yang
U S
US
D000328:Adult; D000368:Aged; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000188:drug therapy*
D009853:Omeprazole