Acid-suppressive effects of rabeprazole: comparing 10mg and 20mg twice daily in Japanese Helicobacter pylori-negative and -positive CYP2C19 extensive metabolisers

Dig Liver Dis. 2006 Nov;38(11):802-8. doi: 10.1016/j.dld.2006.06.002. Epub 2006 Jul 13.

Abstract

Background: Rabeprazole 10mg b.i.d. is often administered as therapy for eradication of Helicobacter pylori (H. pylori) and is also proposed as therapy for refractory gastro-oesophageal reflux disease. However, there has not been a comprehensive assessment of its acid-suppressive effects.

Aims: To compare the acid-suppressive effects of rabeprazole 10mg b.i.d. with 20mg b.i.d. considering H. pylori status.

Subjects: Thirteen H. pylori-negative and eleven H. pylori-positive Japanese CYP2C19 extensive metabolisers (<35 years).

Methods: Intragastric pH was measured for 24h three times in a randomised manner; on day 7 of the repeated administration of rabeprazole 10mg b.i.d. or 20mg b.i.d., or a placebo.

Results: In median intragastric pH value and percent time of pH>3.0, >4.0, >5.0, >6.0, and >7.0 for 24h, no significant differences were observed between the two doses in either H. pylori-negative or H. pylori-positive subjects. At either dose, these parameters were significantly higher in H. pylori-positive subjects than in H. pylori-negative subjects. Nocturnal acid breakthrough occurred in seven and two of the thirteen H. pylori-negative subjects and one and two of the eleven H. pylori-positive subjects at each dose, respectively.

Conclusions: The effects of rabeprazole 10mg b.i.d. were equal to those of 20mg b.i.d. in H. pylori-positive subjects; whereas in H. pylori-negative subjects, 20mg b.i.d. was superior for prevention of nocturnal acid breakthrough.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage*
  • Adult
  • Anti-Ulcer Agents / administration & dosage*
  • Aryl Hydrocarbon Hydroxylases / genetics*
  • Asian People / genetics
  • Cross-Over Studies
  • Cytochrome P-450 CYP2C19
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Gastric Acidity Determination
  • Gastroesophageal Reflux / drug therapy*
  • Gastroesophageal Reflux / microbiology
  • Genotype
  • Helicobacter Infections / drug therapy
  • Helicobacter Infections / genetics*
  • Helicobacter pylori*
  • Humans
  • Hydrogen-Ion Concentration
  • Japan
  • Mixed Function Oxygenases / genetics*
  • Pepsinogen A / blood
  • Pepsinogen C / blood
  • Polymorphism, Genetic
  • Prospective Studies
  • Proton-Translocating ATPases / antagonists & inhibitors
  • Rabeprazole
  • Stomach / chemistry

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Rabeprazole
  • Pepsinogen C
  • Pepsinogen A
  • Mixed Function Oxygenases
  • Aryl Hydrocarbon Hydroxylases
  • CYP2C19 protein, human
  • Cytochrome P-450 CYP2C19
  • Proton-Translocating ATPases