EFFECTIVENESS OF OMEPRAZOLE-AMOXICILLIN-CLARITHROMYCIN (OAC) THERAPY FOR HELICOBACTER-PYLORI INFECTION IN A JAPANESE POPULATION

Background. Omeprazole or lansoprazole, amoxicillin, clarithromycin (P PI/AC) therapy has been reported to provide a high cure rate of H. pyl ori infection with few adverse effects. Effectiveness of H. pylori the rapy may vary among different geographic regions and patient populatio ns. However, there are few reports in Japan as to its effectiveness. W e have, therefore, studied the effectiveness of H. pylori therapy in a large group of Japanese patients. Methods. For this study, 366 H. pyl ori-positive patients with peptic ulcer disease or non-ulcer dyspepsia (263 men and 103 women, mean age 48.5 years) were assigned to 6 group s, each receiving a different PPI/AC regimen. Group 1 received omepraz ole (OPZ) 20 mg, amoxicillin (AMOX) 1500 mg, and clarithromycin (CAM) 400 mg; Group 2 OPZ 40 mg, AXIOX 1500 mg, and CAM 400; and Group 3 OPZ 20 mg, AMOX 2000 mg, and CAM 600 mg daily for 14 days. The group trea ted with lansoprazole (LPZ) 30 mg, AMOX 1500 mg and CAM 400 mg was use d for 14 days in Group 1L. OPZ 20 mg, AMOX 750 mg, and CAM 200 me; wer e given to Group 4 for 28 days and OPZ 20 mg, AMOX 1500 mg, CAM 400 mg was administered to Group 5 for 7 days. Cure of infection was assesse d by the C-13 urea breath test one month after completion of therapy. Results. Cure rates calculated by excluding the patients who showed bo rderline value of C-13 urea breath test (Delta(13)C value between 5 an d 10 parts per thousand in Groups 1, 1L, 2, 3, 4, and 5 were 82.7% (95 % CI; 74-90), 88.9% (76-96), 84.9% (72-93), 81.3% (67-91), 84.6% (72-9 3), and 85.1% (72-93) on an intention-to-treat basis, and 88% (80-94), 95.2% (84-99), 95.6% (85-99), 90.7% (78-97), 95.7% (85-99) and 88.9% (76-96) on a per-protocol basis, respectively. Adverse effects that af fected compliance were observed in 10 of 237 patients on 14-day regime nts, one of 47 on a 28-day regimen and one of 46 on a 7-day regimen. C onclusion. Two weeks PPI/AC therapy is highly effective for cure of H. pylori infection in the Japanese population. The low dose one month r egimen and the one week OAC regimen were also effective in our patient population.