Prospective evaluation of the macrolide antibiotic dirithromycin for the treatment of Helicobacter pylori.
BACKGROUND
Macrolide antibiotics are active in vitro and in vivo against Helicobacter pylori. We assessed a newer macrolide, dirithromycin, for the treatment of H. pylori in two separate studies.


METHODS
Volunteers with H. pylori infection (by 13C-urea breath test) were randomly assigned to 2-week treatment regimens. Study 1: dirithromycin 500 mg q.d.s., dirithromycin 500 mg q.d.s. plus omeprazole 40 mg q.d.s., or dirithromycin 500 mg q.d.s. plus metronidazole 500 mg t.d.s. Study 2: dirithromycin 500 mg q.d.s. plus omeprazole 20 mg b.d., dirithromycin 1000 mg q.d.s. plus omeprazole 20 mg b.d., or amoxycillin 500 mg q.d.s. plus omepirazole 20 mg b.d. Four weeks after the completion of therapy a repeat 13C-urea breath test was done to assess for cure.


RESULTS
No patient taking dirithromycin alone (n = 6) or in combination with omeprazole (n = 26) achieved cure of their infection. Eradication of H. pylori was seen in one of seven patients taking dirithromycin plus metronidazole. Five of 10 patients taking omeprazole-amoxycillin dual therapy had their H. pylori infection cured (P = 0.0007 vs. patients taking dirithromycin plus omeprazole). Eleven (47%) of 32 patients taking dirithromycin alone or combined with omeprazole reported side-effects, but only two (6%) stopped therapy prematurely as a result of side-effects.


CONCLUSIONS
No subject taking dirithromycin alone or in combination with omeprazole had their H. pylori infection cured. Dirithromycin, in the regimen used, shows little promise in the treatment of patients with H. pylori infection.
Laine
L
L
Division of Gastrointestinal and Liver Disease, University of Southern California School of Medicine, Los Angeles 90033, USA.
Stein
C
C
Garcia
F
F
Trujillo
M
M
Estrada
R
R
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D001944:Breath Tests; D004338:Drug Combinations; D004917:Erythromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D018942:Macrolides; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010865:Pilot Projects; D011446:Prospective Studies; D014508:Urea / Q000378:metabolism
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D004338:Drug Combinations; D018942:Macrolides; D008795:Metronidazole; C053853:dirithromycin; D004917:Erythromycin; D000658:Amoxicillin; D014508:Urea; D009853:Omeprazole