Novel bismuth-metronidazole-tetracycline triple-layer tablet for treatment of Helicobacter pylori.
BACKGROUND
Current anti-Helicobacter pylori treatment regimens are costly and because of the increasing antibiotic resistance, are becoming ineffective.


OBJECTIVE
To evaluate a triple-layer tablet containing 100 mg bismuth subcitrate, 250 mg metronidazole, and 250 mg tetracycline in a single triple-layer tablet.


METHODS
H. pylori-infected adult patients received bismuth-metronidazole-tetracycline (two tablets, t.d.s.) and ranitidine (300 mg) once daily for 14 days. Efficacy was determined using 13C-urea breath testing.


RESULTS
Thirty-three of 35 enrolled patients were available for evaluation; using the protocol-specified modified intention-to-treat analysis, five failed treatment, two were lost to follow-up (cure rate per-protocol = 85.7%, intention-to-treat = 78.7%). The cure rate among metronidazole-susceptible strains was 100% (22 of 22) (95% confidence interval 84-100%) compared with 55% (five of nine intention-to-treat) (95% confidence interval 21-86%) among metronidazole-resistant strains. In four cases, therapy was truncated at 4-7 days because of side-effects; yet the treatment was effective in three. The three metronidazole-susceptible but clarithromycin-resistant infections were cured.


CONCLUSIONS
This novel triple-layer tablet combination therapy was effective in all patients with metronidazole-susceptible H. pylori and many of those with resistant organisms. A greater degree of acid suppression may further improve effectiveness.
Graham
D Y
DY
Department of Medicine, VA Medical Center and Baylor College of Medicine, Houston, TX 77030, USA. dgraham@BCM.TMC.edu
Opekun
A R
AR
Belson
G
G
El-Zimaity
H M T
HM
Carlson
M R
MR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000863:Antacids / Q000008:administration & dosage* / Q000009:adverse effects; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D010349:Patient Compliance; D010865:Pilot Projects; D011899:Ranitidine / Q000008:administration & dosage* / Q000009:adverse effects; D013607:Tablets; D013752:Tetracycline / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D000863:Antacids; D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D013607:Tablets; D008795:Metronidazole; D011899:Ranitidine; D013752:Tetracycline; C002791:bismuth tripotassium dicitrate