Helicobacter pylori Eradication Using a 14-day Bismuth Quadruple Therapy Among Hispanic Adults in El Paso, Texas: Preliminary Findings

Abstract

Purpose: Previous studies have shown that the standard triple therapy which consists of two antibiotics, clarithromycin and amoxicillin, and a proton pump inhibitor, results in less than 80% eradication rates of H. pylori infection. A quadruple therapy consisting of three-in-one capsules containing bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride plus omeprazole capsules (Pylera) for ten days was 91% PP in the U.S. and 93% ITT in Europe for eradicating H. pylori (Grade B results). An ongoing study is assessing cure rates of this therapy given for 14 days in an area with high prevalence of metronidazole resistance (i.e., adults in El Paso, Texas). Methods: Subjects were screened for H. pylorii using a urine IgG antibody test and infection status was confirmed by urea breath test. Specimens for cultures were obtained using the minimally invasive non-endoscopic oro-gastric brush method. Fifty subjects have entered and received the 14-day treatment of the combination capsules containing 420 mg of bismuth subcitrate potassium (q.i.d.), 375 mg of metronidazole (q.i.d.), 375 mg of tetracycline hydrochloride (q.i.d.) plus 20 mg of omeprazole (bid). Infection status after treatment was determined by a urea breath test administered at 45+ days. Results: The effectiveness based on PP analysis to date is 100% (lower bound of mid-P 95% CI: 82.9). The prevalence of metronidazole resistant H. pylori (≥8 μg/mL) strains was 44%. The eradication rates according to PP analysis the cure rates were 100% for both metronidazole resistant and metronidazole susceptible strains. No strain was resistant to tetracycline (i.e., all had MIC <2 μg/mL). Overall the therapy was well tolerated. Conclusion: Extending the duration to 14-days of this bismuth-containing quadruple therapy resulted in a high treatment success despite the presence of metronidazole resistance for eradication of H. pylori infections in a Hispanic population. If the excellent results continue, a head to head 10 vs. 14 days comparison will be indicated. (Disclosure: This researcher initiated study was funded by a grant from Aptalis Pharma, Inc, Bridgewater, NJ, USA.) This researcher initiated study was funded by a grant from Aptalis Pharma, Inc, Bridgewater, NJ, USA.