Double-blind, multicenter evaluation of lansoprazole and amoxicillin dual therapy for the cure of Helicobacter pylori infection.
BACKGROUND
Treatment with amoxicillin plus omeprazole results in disappointing cure rates of Helicobacter pylori infection. The minimal inhibitory concentration of lansoprazole for H. pylori in vitro is lower than that for omeprazole, prompting interest in treatment with amoxicillin plus lansoprazole.


METHODS
H. pylori-infected patients with endoscopically documented duodenal ulcer either currently or within the past year were randomized to 14 days of (1) lansoprazole, 30 mg bid, plus amoxicillin, 1 gm tid; (2) lansoprazole, 30 mg tid, plus amoxicillin, 1 gm tid; (3) lansoprazole, 30 mg tid alone; or (4) amoxicillin, 1 gm tid alone. Endoscopy was done at enrollment and at 4 to 6 weeks after completion of treatment or for recurrent symptoms. H. pylori status was assessed by culture and histology. Ulcer prevalence was evaluated at follow-up endoscopy.


RESULTS
Two hundred sixty-two patients met enrollment criteria and were treated. By per-protocol analysis, H. pylori infection was cured in 57% of those treated with lansoprazole twice daily plus amoxicillin and in 67% of those treated with lansoprazole three times daily plus amoxicillin, compared with 0% treated with lansoprazole alone or amoxicillin alone (p < .001 for dual therapy versus either monotherapy). Amoxicillin resistance was not observed. At follow-up endoscopy, ulcer prevalence was 17% in patients treated with lansoprazole twice daily plus amoxicillin, 23% in those treated with lansoprazole three times daily plus amoxicillin, 33% in those treated with lansoprazole alone, and 35% in those treated with amoxicillin alone (p = .024; lansoprazole twice daily plus amoxicillin versus amoxicillin alone).


CONCLUSIONS
Treatment with amoxicillin plus lansoprazole, 30 mg tid, led to cure of H. pylori infection in 67% of patients with active or recently healed duodenal ulcer.
Harford
W
W
Veterans Affairs Medical Center, Dallas, TX 75216, USA.
Lanza
F
F
Arora
A
A
Graham
D
D
Haber
M
M
Weissfeld
A
A
Rose
P
P
Siepman
N
N
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017291:Clarithromycin / Q000494:pharmacology; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000209:etiology; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology / Q000382:microbiology; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005756:Gastritis / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D064747:Lansoprazole; D008297:Male; D008795:Metronidazole / Q000494:pharmacology; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010406:Penicillins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015995:Prevalence; D054328:Proton Pump Inhibitors; D012107:Research Design; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D004791:Enzyme Inhibitors; D010406:Penicillins; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole