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  • Helicobacter pylori first-line and rescue treatments in the presence of penicillin allergy.

Helicobacter pylori first-line and rescue treatments in the presence of penicillin allergy.

Digestive diseases and sciences (2014-09-23)
Javier P Gisbert, Jesús Barrio, Inés Modolell, Javier Molina-Infante, Angeles Perez Aisa, Manuel Castro-Fernández, Luis Rodrigo, Angel Cosme, Jose Luis Gisbert, Miguel Fernández-Bermejo, Santiago Marcos, Alicia C Marín, Adrián G McNicholl
ABSTRACT

Helicobacter pylori eradication is a challenge in penicillin allergy. To assess the efficacy and safety of first-line and rescue treatments in patients allergic to penicillin. Prospective multicenter study. Patients allergic to penicillin were given a first-line treatment comprising (a) 7-day omeprazole-clarithromycin-metronidazole and (b) 10-day omeprazole-bismuth-tetracycline-metronidazole. Rescue treatments were as follows: (a) bismuth quadruple therapy; (b) 10-day PPI-clarithromycin-levofloxacin; and (c) 10-day PPI-clarithromycin-rifabutin. Eradication was confirmed by (13)C-urea breath test. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by questionnaires. In total, 267 consecutive treatments were included. (1) First-line treatment: Per-protocol and intention-to-treat eradication rates with omeprazole-clarithromycin-metronidazole were 59 % (62/105; 95 % CI 49-62 %) and 57 % (64/112; 95 % CI 47-67 %). Respective figures for PPI-bismuth-tetracycline-metronidazole were 75 % (37/49; 95 % CI 62-89 %) and 74 % (37/50; 95 % CI (61-87 %) (p < 0.05). Compliance with treatment was 94 and 98 %, respectively. Adverse events were reported in 14 % with both regimens (all mild). (2) Second-line treatment: Intention-to-treat eradication rate with omeprazole-clarithromycin-levofloxacin was 64 % both after triple and quadruple failure; compliance was 88-100 %, with 23-29 % adverse effects (all mild). (3) Third-/fourth-line treatment: Intention-to-treat eradication rate with PPI-clarithromycin-rifabutin was 22 %. In allergic to penicillin patients, a first-line treatment with a bismuth-containing quadruple therapy (PPI-bismuth-tetracycline-metronidazole) seems to be a better option than the triple PPI-clarithromycin-metronidazole regimen. A levofloxacin-based regimen (together with a PPI and clarithromycin) represents a second-line rescue option in the presence of penicillin allergy.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Clarithromycin, ≥95% (HPLC)
Supelco
Metronidazole, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Clarithromycin, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Metronidazole, VETRANAL®, analytical standard
Sigma-Aldrich
Clarithromycin, 96.0-102.0% (HPLC)
Sigma-Aldrich
Tetracycline, 98.0-102.0% (HPLC)
Sigma-Aldrich
Tetracycline, 98.0-102.0% (HPLC)
Supelco
Metronidazole, analytical standard
Clarithromycin for peak identification, European Pharmacopoeia (EP) Reference Standard
USP
Clarithromycin, United States Pharmacopeia (USP) Reference Standard
Clarithromycin, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Metronidazole, BioXtra
Metronidazole, European Pharmacopoeia (EP) Reference Standard
Rifabutin, European Pharmacopoeia (EP) Reference Standard
USP
Rifabutin, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Rifabutin, >98% (HPLC), powder
Supelco
Omeprazole, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Tetracycline hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Tetracycline hydrochloride, VETRANAL®, analytical standard
USP
Clarithromycin Identity, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Bismuth, powder, −100 mesh, 99% trace metals basis
Sigma-Aldrich
Bismuth, shot, 4-30 mesh, 99.9% trace metals basis
Sigma-Aldrich
Bismuth, beads, 1-5 mm, 99.999% trace metals basis
Sigma-Aldrich
Bismuth, granular, ≥99.99% trace metals basis
Sigma-Aldrich
Bismuth, pieces, 1-12 mm, 99.999% trace metals basis
Sigma-Aldrich
Levofloxacin, 98.0-102.0% anhydrous basis (HPLC)
Sigma-Aldrich
Bismuth, powder, −100 mesh, ≥99.99% trace metals basis
Sigma-Aldrich
Tetracycline hydrochloride, meets USP testing specifications
Sigma-Aldrich
Tetracycline hydrochloride, powder
Sigma-Aldrich
Omeprazole, solid