5-Day Therapy Effective Against H pylori infection

Joe Barber Jr, PhD

July 03, 2012

June 3, 2012 — A 5-day levofloxacin-containing concomitant regimen effectively eradicates Helicobacter pylori infection as effectively as a 10-day sequential regimen, according to the findings of a prospective, randomized controlled trial.

Alessandro Federico, MD, from the Second University of Naples in Italy, and colleagues reported their findings in an article published online April 5 and in the July issue of Gastroenterology.

The authors note that resistance has limited the efficacy of many regimens currently used to treat H pylori infection. "Although H pylori is susceptible to a number of antimicrobials, H pylori infection has proven challenging to cure because the prevalence of bacterial strains resistant to the most commonly used antimicrobials, in particular clarithromycin...increases," the authors write.

"As a result, currently recommended first-line therapies both in the United States and Europe achieve a 75%-80% eradication rate, which is not acceptable."

The authors compared the efficacy of 5-day concomitant therapy (esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, levofloxacin 500 mg twice daily, and tinidazole 500 mg twice daily for 5 days) to that of 10-day sequential therapy (esomeprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days followed by esomeprazole 40 mg twice daily, levofloxacin 500 mg twice daily, and tinidazole 500 mg twice daily for 5 days) in a group of 180 patients (n = 90 each group). In the intention-to-treat analysis, the 5-day regimen achieved a similar eradication rate as the 10-day regimen (5-day: 83/90 patients [92.2%; 95% confidence interval [CI], 84.0% - 95.8%]; 10-day: 84/90 patients [93.3%; 95% CI, 86.9% - 97.3%; P = .774).

The authors included patients at least 18 years of age who had confirmed H pylori infection (according to 13C urea breath test positivity or both the rapid urease test and histology in patients who underwent endoscopy) and who had never received eradication treatment. The exclusion criteria included previous treatment for H pylori infection, previous use of acid secretion inhibitors and/or antibiotics in the 6 weeks before the study, and gastrointestinal malignancy.

In the per protocol analysis, the 5-day regimen achieved eradiation in 83 of 86 patients (96.5%; 95% CI, 91% - 99%) compared with 84 of 88 patients (95.5%; 95% CI, 89.6% - 98.5%) for the 10-day regimen (P = .769). The incidence rates of adverse events were similar between the 2 regimens, and adverse events caused therapy discontinuation in 4 patients receiving the 5-day regimen and 2 patients receiving the 10-day regimen.

The cost of the 5-day regimen was $43.50 compared with $52.30 for the 10-day regimen. The limitations of the study included the reliance on a single 13C urea breath test to confirm H pylori status in 45% of patients.

The authors indicate that the 5-day regimen may be a novel treatment option for H pylori infection. "[T]his eradication regimen is easy to follow for the patient and well tolerated," the authors write. "Therefore, this regimen may represent an effective, reduced cost, and safe first-line therapeutic alternative in areas where the efficacy of triple therapy is unacceptably low."

In a related editorial, David Y. Graham, MD, from Baylor College of Medicine in Houston, Texas, and Akiko Shiotani, MD, PhD, from the Kawasaki Medical School in Okayama, Japan, note that additional work is needed regarding fluoroquinolone therapies. "All regimens should be optimized, meaning identification of the preferred components, including drugs, doses, formulations, number and timing of administrations per day, relation to meals, and duration of therapy that provides the simplest, best accepted, and cheapest regimen that also maintains the effectiveness at >90% or 95%," the editorialists write. "One would hope to soon see a series of pilot studies exploring whether the results remain unchanged with changes in the PPI or its relative dose, the fluoroquinolone, and whether fluoroquinolone dosing twice a day is needed."

Dr. Graham is a paid consultant for Novartis and RedHill Biopharma. The other authors and commentator have disclosed no relevant financial relationships.

Gastroenterology. 2012;143:55-61. Article abstract, Editorial full text

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