Effect of administration of ranitidine bismuth citrate with food on the suppression and eradication of Helicobacter pylori in infected volunteers.
OBJECTIVE
This study examined the effect of administration with food on the ability of ranitidine bismuth citrate to suppress and eradicate Helicobacter pylori in 41 infected volunteers.


RESULTS
After a 7-day course of treatment with ranitidine bismuth citrate (400 mg b.i.d.), 90% (18/20) of subjects who received the drug with food compared with 55% (11/20) of subjects who received the drug without food tested H. pylori-negative in a 13C-urea breath test (p = 0.031). Follow-up 13C-urea breath tests performed at least 3 months after therapy showed that H. pylori was eradicated in 14% (2/14) of subjects who received ranitidine bismuth citrate with food compared with 0% (0/18) of subjects who received ranitidine bismuth citrate without food (p = 0.183). The incidence of potentially drug-related adverse events was similar regardless of whether subjects received ranitidine bismuth citrate with or without food. Headache was the most common potentially drug-related adverse event.


CONCLUSIONS
These data demonstrate that administration of ranitidine bismuth citrate with food compared with without food significantly improves the suppression of H. pylori in infected volunteers.
Webb
D D
DD
Glaxo Research Institute, Research Triangle Park, North Carolina, USA.
Ciociola
A A
AA
Perschy
T B
TB
Goodwin
B B
BB
D000328:Adult; D001729:Bismuth / Q000008:administration & dosage* / Q000009:adverse effects; D001944:Breath Tests; D002250:Carbon Radioisotopes; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D005502:Food; D006261:Headache / Q000139:chemically induced / Q000453:epidemiology; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006635:Histamine H2 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D008297:Male; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D014508:Urea
D002250:Carbon Radioisotopes; D006635:Histamine H2 Antagonists; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D014508:Urea; D001729:Bismuth