Helicobacter pylori infection occurs in children and adults worldwide.
Standard triple therapy of omeprazole, amoxicillin and clarithromycin (OAC) may not be optimal.
Dr Thieroff-Ekerdt and colleagues from Germany evaluated quadruple therapy with bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, given with omeprazole in H. pylori infected subjects who failed previous OAC eradication therapy.
The team performed a multicenter, open-label, single-arm, multinational study.
Helicobacter pylori-positive subjects who had failed ≥1 previous course of OAC therapy with or without up to 3 supplemental treatments in the previous year.
|Metronidazole resistance was observed in 33% of subjects|
|Alimentary Pharmacology & Therapeutics|
Subjects were treated for 10 days with a combination formulation containing bismuth subcitrate potassium 140 mg, tetracycline hydrochloride 125 mg, and metronidazole 125 mg, 3 capsules 4 times daily, and omeprazole 20 mg twice daily.
The team's primary endpoint was H. pylori eradication rate defined as one negative 13C-urea breath test ≥28 days post-treatment.
Helicobacter pylori eradication rates ranged from 93% to 94% in the intent-to-treat population, and to 95% in the per protocol population.
The research team found no clinically meaningful differences when analyzed by country.
Metronidazole resistance was observed in 33% of subjects, and clarithromycin resistance in 63% of subjects.
The team observed that 67% of subjects reported 87 adverse events, and only 2% discontinued the study for an adverse event.
Dr Thieroff-Ekerdt's team concludes, "A quadruple regimen of bismuth, metronidazole and tetracycline plus omeprazole produces a high eradication rate in subjects previously failing H. pylori eradication regimens."
"This bismuth-based regimen offers an effective option as rescue therapy."