Efficacy of 1 week omeprazole or lansoprazole-amoxycillin-clarithromycin therapy for Helicobacter pylori infection in the Japanese population.
BACKGROUND
The effectiveness of curative therapy for Helicobacter pylori may vary according to the geographic region and patient population, thus the efficacy of each treatment regimen should be determined according to the specific patient population. However, there is no literature available concerning the efficacy of 1 week omeprazole-amoxycillin-clarithromycin (OAC) regimens for the cure of H. pylori infection in Japan.


METHODS
Helicobacter pylori-positive patients (224) with peptic ulcer disease or non-ulcer dyspepsia were randomized to receive one of three different omeprazole or lansoprazole-amoxycillin-clarithromycin (PPI/AC) regimens for 7 days: (1) OAC 20 regimen (n = 76), omeprazole (OPZ) 20 mg daily, amoxycillin (AMOX) 500 mg t.d.s. and clarithromycin (CAM) 200 mg b.d.; (2) LAC 30 regimen (n = 73), Lansoprazole (LPZ) 30 mg daily, AMOX 500 mg t.d.s. and CAM 200 mg b.d.; and (3) OPZ 40 regimen (n = 75), OPZ 20 b.d., AMOX 500 mg t.d.s. and CAM 200 mg b.d. Cure of the infection was determined by the [13C]-urea breath test, 1 month after completion of the treatment.


RESULTS
Intention-to-treat based cure rates for OAC 20, LAC 30 and OAC 40 regimens were 75.0% (95% CI, 64-84%), 82.2% (95%, CI 72-90), and 80.0% (95% CI, 69-88), respectively and per-protocol based cure rates of these regimens were 79.2% (95% CI, 68-88%), 83.3% (95%, CI 73-91), and 83.1% (95% CI, 72-91%), respectively. Adverse effects, which included diarrhoea, glossitis or skin rash, were reported by 26.1% of the patients. However, these were mild and did not affect compliance.


CONCLUSIONS
One week PPI/AC regimens for H. pylori infection with smaller proton pump inhibitors and antimicrobial dosages compared to regimens used in Western countries were revealed to provide sufficient cure rate (more than 80% by ITT analysis) with mild adverse effects in the Japanese population.
Miwa
H
H
Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan.
Nagahara
A
A
Sato
K
K
Ohkura
R
R
Murai
T
T
Shimizu
H
H
Watanabe
S
S
Sato
N
N
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000453:epidemiology; D016480:Helicobacter pylori; D006801:Humans; D007564:Japan / Q000453:epidemiology; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000382:microbiology; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D013997:Time Factors
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole