Randomized trial of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin
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Randomized trial of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin. / Miehlke, S; Hansky, K; Schneider-Brachert, W; Kirsch, C; Morgner, A; Madisch, A; Kuhlisch, E; Bästlein, E; Jacobs, E; Bayerdörffer, E; Lehn, N; Stolte, M.
In: ALIMENT PHARM THER, Vol. 24, No. 2, 15.07.2006, p. 395-403.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Randomized trial of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin
AU - Miehlke, S
AU - Hansky, K
AU - Schneider-Brachert, W
AU - Kirsch, C
AU - Morgner, A
AU - Madisch, A
AU - Kuhlisch, E
AU - Bästlein, E
AU - Jacobs, E
AU - Bayerdörffer, E
AU - Lehn, N
AU - Stolte, M
PY - 2006/7/15
Y1 - 2006/7/15
N2 - BACKGROUND: The clinical management of Helicobacter pylori infected patients who failed standard eradication therapies remains a challenge.AIM: To investigate the efficacy of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of H. pylori, and the correlation between cytochrome P450 2C19 (CYP2C19) polymorphisms and treatment outcome.METHODS: Patients infected with H. pylori resistant to both metronidazole and clarithromycin (n = 145) were randomized to either esomeprazole 20 mg, rifabutin 150 mg and amoxicillin 1 g, each given b.d. for 7 days (ERA), or to omeprazole 40 mg and amoxicillin 1000 mg, each given t.d.s. for 14 days (OA). Crossover therapy was offered in cases of persistent infection. CYP2C19 polymorphisms were determined by polymerase chain reaction restriction fragment length polymorphism.RESULTS: Intention-to-treat and per-protocol eradication rates were: ERA 74% (62.4-83.6) and 78% (66.7-87.3); high-dose OA 70% (57.5-79.7) and 75% (62.5-84.5). Crossover therapy was successful in seven of 10 patients with ERA and in eight of 10 patients with OA. Premature discontinuation of treatment occurred in 2% and 5% of patients, respectively. There was only a non-significant trend to lower eradication rates in homozygous extensive metabolizers.CONCLUSIONS: Triple therapy with esomeprazole, rifabutin and amoxicillin and high-dose omeprazole/amoxicillin are comparable and effective and safe for rescue therapy of H. pylori regardless of the patient's CYP2C19 genotype.
AB - BACKGROUND: The clinical management of Helicobacter pylori infected patients who failed standard eradication therapies remains a challenge.AIM: To investigate the efficacy of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of H. pylori, and the correlation between cytochrome P450 2C19 (CYP2C19) polymorphisms and treatment outcome.METHODS: Patients infected with H. pylori resistant to both metronidazole and clarithromycin (n = 145) were randomized to either esomeprazole 20 mg, rifabutin 150 mg and amoxicillin 1 g, each given b.d. for 7 days (ERA), or to omeprazole 40 mg and amoxicillin 1000 mg, each given t.d.s. for 14 days (OA). Crossover therapy was offered in cases of persistent infection. CYP2C19 polymorphisms were determined by polymerase chain reaction restriction fragment length polymorphism.RESULTS: Intention-to-treat and per-protocol eradication rates were: ERA 74% (62.4-83.6) and 78% (66.7-87.3); high-dose OA 70% (57.5-79.7) and 75% (62.5-84.5). Crossover therapy was successful in seven of 10 patients with ERA and in eight of 10 patients with OA. Premature discontinuation of treatment occurred in 2% and 5% of patients, respectively. There was only a non-significant trend to lower eradication rates in homozygous extensive metabolizers.CONCLUSIONS: Triple therapy with esomeprazole, rifabutin and amoxicillin and high-dose omeprazole/amoxicillin are comparable and effective and safe for rescue therapy of H. pylori regardless of the patient's CYP2C19 genotype.
KW - Adolescent
KW - Adult
KW - Aged
KW - Amoxicillin
KW - Anti-Bacterial Agents
KW - Anti-Ulcer Agents
KW - Clarithromycin
KW - Cross-Over Studies
KW - Drug Resistance, Bacterial
KW - Drug Therapy, Combination
KW - Esomeprazole
KW - Female
KW - Helicobacter Infections
KW - Helicobacter pylori
KW - Humans
KW - Male
KW - Metronidazole
KW - Middle Aged
KW - Omeprazole
KW - Prospective Studies
KW - Rifabutin
KW - Treatment Outcome
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
U2 - 10.1111/j.1365-2036.2006.02993.x
DO - 10.1111/j.1365-2036.2006.02993.x
M3 - SCORING: Journal article
C2 - 16842467
VL - 24
SP - 395
EP - 403
JO - ALIMENT PHARM THER
JF - ALIMENT PHARM THER
SN - 0269-2813
IS - 2
ER -