Lafutidine, a novel histamine H2-receptor antagonist, vs lansoprazole in combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori.
BACKGROUND
In contrast to the growing amount of data concerning proton pump inhibitor-based triple therapy for Helicobacter pylori infection, it is still controversial whether proton pump inhibitor can be replaced by H2 receptor antagonist without compromising efficacy. Lafutidine is a novel potent H2 receptor antagonist with gastroprotective activities such as enhancement of gastric mucosal blood flow.


METHODS
122 outpatients with positive cultures and subsequent successful cultivation of H. pylori for antimicrobial susceptibility tests were randomized to receive a 7-day course of either lafutidine (20 mg twice daily) or lansoprazole (30 mg twice daily), plus clarithromycin (200 mg twice daily) and amoxicillin (750 mg twice daily). Eradication was considered successful if the rapid urease test, culture, histology and [13]C-urea breath test were all negative at least 4 weeks after cessation of therapy. Cytochrome p450 2C19 genotype status using polymerase chain reaction-restriction fragment length polymorphism was also studied.


RESULTS
On intention-to-treat basis, H. pylori cure was achieved in 52 of 61 (85.2%) patients and 49 of 61 (80.3%) patients for the lafutidine- and lansoprazole-based therapies, respectively. The predicted 95% confidential intervals for the 4.9% of the difference were -1.8-11.6%. Using per protocol analysis, the eradication rates were 88.2% (52/59) and 84.5% (49/58), respectively. The predicted 95% confidential intervals for the 3.7% of the difference were -2.6-10.0%. Adverse events were observed in five and six patients, from the lafutidine and lansoprazole groups, respectively, but they were generally mild. Genetic predisposition of cytochrome p450 2C19 had no significant influence on treatment outcome in both regimens.


CONCLUSIONS
The lafutidine-clarithromycin-amoxicillin therapy yielded satisfactory results for eradicating H. pylori, which was comparable with those of the lansoprazole-based regimen with the same drug combination.
Isomoto
Hajime
H
Second Department of Internal Medicine, Nagasaki University School of Medicine, 1-7-1 Sakamoto, Nagasaki, Japan.
Inoue
Kenichiro
K
Furusu
Hisashi
H
Nishiyama
Hitoshi
H
Shikuwa
Saburo
S
Omagari
Katsuhisa
K
Mizuta
Yohei
Y
Murase
Kunihiko
K
Murata
Ikuo
I
Kohno
Shigeru
S
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000081:Acetamides / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001189:Aryl Hydrocarbon Hydroxylases / Q000235:genetics; D017291:Clarithromycin / Q000008:administration & dosage; D065731:Cytochrome P-450 CYP2C19; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000235:genetics; D016480:Helicobacter pylori / Q000187:drug effects*; D006635:Histamine H2 Antagonists / Q000008:administration & dosage*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D006899:Mixed Function Oxygenases / Q000235:genetics; D009853:Omeprazole / Q000008:administration & dosage* / Q000031:analogs & derivatives; D010406:Penicillins / Q000008:administration & dosage; D010880:Piperidines / Q000008:administration & dosage*; D011446:Prospective Studies; D011725:Pyridines / Q000008:administration & dosage*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000081:Acetamides; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D010406:Penicillins; D010880:Piperidines; D011725:Pyridines; D064747:Lansoprazole; C076948:lafutidine; D000658:Amoxicillin; D006899:Mixed Function Oxygenases; D001189:Aryl Hydrocarbon Hydroxylases; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D017291:Clarithromycin; D009853:Omeprazole