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Sequential Regimen Beats Triple Combination for Helicobacter Pylori Eradication: Presented at GASTRO 2009 (UEGW/WCOG)

By Sara Freeman

LONDON -- December 1, 2009 -- Higher eradication rates for Helicobacter pylori can be achieved using a 10-day sequential regimen rather than a conventional 14-day triple regimen, researchers reported at GASTRO 2009.

Giving the proton pump inhibitor (PPI) pantoprazole 40 mg first in combination with amoxicillin 1,000 mg for 5 days, and then together with clarithromycin 500 mg and metronidazole 500 mg for a further 5 days successfully eradicated the gut bacterium in 85.9% of patients in an intent-to-treat analysis.

By comparison, a standard 14-day triple regimen of the PPI 40 mg plus clarithromycin 500 mg and amoxicillin 1,000 mg eradicated H pylori in 75% of patients (P = .006).

"In the eradication of H pylori, the 10-day sequential regimen appears to be more effective than the 14-day standard triple regimen," said lead investigator Sung Jung Kim, MD, Hallym University Medical Center, Chuncheon-si, South Korea, speaking here on November 24.

The prospective, double-blind study involved 409 patients with dyspepsia or peptic ulcer disease infected with H pylori. Infection was confirmed by histology, the rapid urease test, and laboratory culture at baseline. Eradication was assessed by the urea breath test.

A total of 205 patients (55% male, mean age 51.8 years) were randomised to receive the 10-day sequential therapy and another 205 patients (51% female, mean age 50.6 years) were given the standard 14-day triple regimen.

A per-protocol analysis demonstrated an even higher eradication rate with the 10-day regimen than with the standard 14-day regimen than that seen in the intent-to-treat analysis. H pylori was eradicated in a total of 92.6% and 85% of patients in each group, respectively, in the per-protocol analysis (P =.0143).

Adverse events were reported in a similar number of patients in each arm -- 36 (18.6%) of the sequential-therapy patients and 24 (13.3%) of the standard-therapy patients (P = .143). Diarrhoea and abdominal pain were the most commonly reported side effects, occurring in a similar percentage of patients in each group (6.8/6.1% vs 5.5%/4.4%, respectively; nonsignificant).

Compliance with the drug regimens was good, and was similar between the groups, with less than 90% adherence reported in only 6 (3.2%) and 5 (2.8%) patients in each arm, respectively.

"Considering previous studies showing superiority of sequential therapy to 7- or 10-day standard regimen, 10-day sequential therapy may be considered the new standard regimen for the eradication of H pylori," Dr. Kim concluded.

GASTRO 2009 is jointly organised by the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED), and the British Society of Gastroenterology (BSG).

[Presentation title: Efficacy of Sequential Therapy Versus 14-Day Standard Triple Therapy in Eradication of Helicobacter Pylori: A Randomized, Prospective Study. Abstract P758]

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