Randomized study of two "rescue" therapies for Helicobacter pylori-infected patients after failure of standard triple therapies

Francesco Perri, Virginia Festa, Rocco Clemente, Maria Rosaria Villani, Michele Quitadamo, Nazario Caruso, Michele Li Bergoli, Angelo Andriulli

Research output: Contribution to journalArticle

142 Citations (Scopus)

Abstract

OBJECTIVES: A novel rifabutin-based therapy is able to cure Helicobacter pylori infection in most patients who have failed eradication after standard proton pump inhibitor (PPI)-based triple therapy. We compared this regimen with the quadruple therapy. METHODS: A total of 135 patients were randomized into three groups who were treated for 10 days with pantoprazole 40 mg b.i.d., amoxycillin 1 g b.i.d., and rifabutin 150 mg o.d. (RAP150 group), or 300 mg o.d. (RAP300 group), and pantoprazole 40 mg b.i.d., metronidazole 250 mg t.i.d., bismuth citrate 240 mg b.i.d., and tetracycline 500 mg q.i.d. (QT group). Before therapy, patients underwent endoscopy with biopsies for histology, culture and antibiotic susceptibility tests. H. pylori eradication was assessed by the 13C-urea breath test. RESULTS: On intention-to-treat analysis, eradication rates (with 95% confidence intervals [CI]) were 66.6% (53-80%) in the RAP150 and QT groups, respectively, and 86.6% (76-96%) in RAP300 group (p <0.025). Most patients harboring metronidazole- and clarithromycin-resistant strains were eradicated at an equal rate by each of the three regimens. Side effects were observed in 9% and 11% of rifabutin-treated patients, and in 47% of those on quadruple therapy (p <0.0001). CONCLUSIONS: In patients who failed standard eradicating treatments, a 10-day course of rifabutin with pantoprazole and amoxycillin is more effective and well tolerated than the quadruple therapy.

Original languageEnglish
Pages (from-to)58-62
Number of pages5
JournalAmerican Journal of Gastroenterology
Volume96
Issue number1
DOIs
Publication statusPublished - 2001

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Helicobacter pylori
Rifabutin
Amoxicillin
Metronidazole
Therapeutics
Intention to Treat Analysis
Breath Tests
Clarithromycin
Proton Pump Inhibitors
Helicobacter Infections
Tetracycline
Endoscopy
Urea
Histology
Confidence Intervals
Anti-Bacterial Agents
Biopsy
pantoprazole

ASJC Scopus subject areas

  • Gastroenterology

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Randomized study of two "rescue" therapies for Helicobacter pylori-infected patients after failure of standard triple therapies. / Perri, Francesco; Festa, Virginia; Clemente, Rocco; Villani, Maria Rosaria; Quitadamo, Michele; Caruso, Nazario; Li Bergoli, Michele; Andriulli, Angelo.

In: American Journal of Gastroenterology, Vol. 96, No. 1, 2001, p. 58-62.

Research output: Contribution to journalArticle

Perri, Francesco ; Festa, Virginia ; Clemente, Rocco ; Villani, Maria Rosaria ; Quitadamo, Michele ; Caruso, Nazario ; Li Bergoli, Michele ; Andriulli, Angelo. / Randomized study of two "rescue" therapies for Helicobacter pylori-infected patients after failure of standard triple therapies. In: American Journal of Gastroenterology. 2001 ; Vol. 96, No. 1. pp. 58-62.
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AU - Clemente, Rocco

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AU - Quitadamo, Michele

AU - Caruso, Nazario

AU - Li Bergoli, Michele

AU - Andriulli, Angelo

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N2 - OBJECTIVES: A novel rifabutin-based therapy is able to cure Helicobacter pylori infection in most patients who have failed eradication after standard proton pump inhibitor (PPI)-based triple therapy. We compared this regimen with the quadruple therapy. METHODS: A total of 135 patients were randomized into three groups who were treated for 10 days with pantoprazole 40 mg b.i.d., amoxycillin 1 g b.i.d., and rifabutin 150 mg o.d. (RAP150 group), or 300 mg o.d. (RAP300 group), and pantoprazole 40 mg b.i.d., metronidazole 250 mg t.i.d., bismuth citrate 240 mg b.i.d., and tetracycline 500 mg q.i.d. (QT group). Before therapy, patients underwent endoscopy with biopsies for histology, culture and antibiotic susceptibility tests. H. pylori eradication was assessed by the 13C-urea breath test. RESULTS: On intention-to-treat analysis, eradication rates (with 95% confidence intervals [CI]) were 66.6% (53-80%) in the RAP150 and QT groups, respectively, and 86.6% (76-96%) in RAP300 group (p <0.025). Most patients harboring metronidazole- and clarithromycin-resistant strains were eradicated at an equal rate by each of the three regimens. Side effects were observed in 9% and 11% of rifabutin-treated patients, and in 47% of those on quadruple therapy (p <0.0001). CONCLUSIONS: In patients who failed standard eradicating treatments, a 10-day course of rifabutin with pantoprazole and amoxycillin is more effective and well tolerated than the quadruple therapy.

AB - OBJECTIVES: A novel rifabutin-based therapy is able to cure Helicobacter pylori infection in most patients who have failed eradication after standard proton pump inhibitor (PPI)-based triple therapy. We compared this regimen with the quadruple therapy. METHODS: A total of 135 patients were randomized into three groups who were treated for 10 days with pantoprazole 40 mg b.i.d., amoxycillin 1 g b.i.d., and rifabutin 150 mg o.d. (RAP150 group), or 300 mg o.d. (RAP300 group), and pantoprazole 40 mg b.i.d., metronidazole 250 mg t.i.d., bismuth citrate 240 mg b.i.d., and tetracycline 500 mg q.i.d. (QT group). Before therapy, patients underwent endoscopy with biopsies for histology, culture and antibiotic susceptibility tests. H. pylori eradication was assessed by the 13C-urea breath test. RESULTS: On intention-to-treat analysis, eradication rates (with 95% confidence intervals [CI]) were 66.6% (53-80%) in the RAP150 and QT groups, respectively, and 86.6% (76-96%) in RAP300 group (p <0.025). Most patients harboring metronidazole- and clarithromycin-resistant strains were eradicated at an equal rate by each of the three regimens. Side effects were observed in 9% and 11% of rifabutin-treated patients, and in 47% of those on quadruple therapy (p <0.0001). CONCLUSIONS: In patients who failed standard eradicating treatments, a 10-day course of rifabutin with pantoprazole and amoxycillin is more effective and well tolerated than the quadruple therapy.

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