Efficacy and tolerability of first-line triple therapy with levofloxacin and amoxicillin plus esomeprazole or rabeprazole for the eradication of Helicobacter pylori infection and the effect of CYP2C19 genotype: A 1-week, randomized, open-label study ...
Abstract: Background: First-line triple therapy with levofloxa- cin and amoxicillin plus a proton pump inhibitor has been reported to be effective and well tolerated in the eradication of Helicobacter pylori infection. Studies have reported that cytochrome P450 (CYP) 2C19 genotypes may affect the cl...
| Publicado en: | Clinical Therapeutics Vol. 32; no. 12; pp. 2003 - 2012 |
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| Autores principales: | , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Elsevier B.V.
Nov2010
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104950138&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104950138 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01492918 H3L jtl: Clinical Therapeutics issn: 01492918 maglogo: N pubinfo: dt: Nov2010 vid: 32 iid: 12 pid: 82545 pub: Elsevier B.V. place: Philadelphia, Pennsylvania artinfo: ui: 104950138 55500708 10.1016/j.clinthera.2010.11.005 104950138 ppf: 2003 ppct: 9 formats: tig: atl: Efficacy and tolerability of first-line triple therapy with levofloxacin and amoxicillin plus esomeprazole or rabeprazole for the eradication of Helicobacter pylori infection and the effect of CYP2C19 genotype: A 1-week, randomized, open-label study ... aug: au: Pan X Li Y Qiu Y Tang Q Qian B Yao L Shi R Zhang G affil: Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China sug: subj: Helicobacter Infections Drug Therapy Genotype Treatment Outcomes Human Randomized Controlled Trials China Antibiotics Administration and Dosage Drug Combinations Adverse Drug Event Proton Pump Inhibitors Administration and Dosage Patient Compliance Analysis of Variance Fisher's Exact Test Confidence Intervals Data Analysis Software Male Female Adult Middle Age Descriptive Statistics Prospective Studies Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: Abstract: Background: First-line triple therapy with levofloxa- cin and amoxicillin plus a proton pump inhibitor has been reported to be effective and well tolerated in the eradication of Helicobacter pylori infection. Studies have reported that cytochrome P450 (CYP) 2C19 genotypes may affect the clinical efficacy of clarithromycinbased triple therapies, although there is only one report of such an effect with levofloxacin-based triple therapies. Objectives: This study evaluated the clinical efficacy and tolerability of a 1-week course of triple therapy with levofloxacin and amoxicillin plus esomeprazole or rabeprazole as first-line treatment for H pylori infection in Chinese adults. It also investigated whether CYP2C19 genotype status affected rates of H pylori eradication with these regimens. Methods: Consecutive patients undergoing upper endoscopy at the First Affiliated Hospital of Nanjing Medical University between May 2008 and January 2009 were evaluated for inclusion. Eligible patients were those who tested positive for H pylori infection on biopsy-based testing (ie, histology and an in-house rapid urease test) or a validated 13C-urea breath test. Patients were randomized in an open-label fashion to receive levofloxacin 500 mg/d and amoxicillin 1000 mg BID plus either esomeprazole 20 mg BID (group A), esomeprazole 40 mg BID (group B), or rabeprazole 10 mg BID (group C) for 1 week. Patients were asked to record adverse events in a diary. Trained study assistants contacted patients by telephone within the first week after completion of therapy to collect data on drug compliance and adverse events. H pylori status was determined 4 weeks after the end of therapy using a 13C-urea breath test. Rates of H pylori eradication were calculated in the intent-to-treat (ITT) and per-protocol (PP) populations. CYP2C19 genotype was determined by the polymerase chain reaction-restriction fragment-length polymorphism method. Results: Of 199 consecutive patients screened for eligibility, 184 H pylori-positive patients were enrolled in the study (61 in group A, 62 in group B, and 61 in group C). The overall sample was balanced in terms of age, sex, endoscopic diagnosis, and history of smoking. Rates of H pylori eradication in the ITT and PP populations were as follows: group A—85.2% (52/61) and 86.7% (52/60), respectively; group B—87.1% (54/62) and 90.0% (54/60); and group C—75.4% (46/61) and 75.4% (46/61). There were no significant differences in eradication rates among groups, nor were there any differences in rates of compliance (98.4%, 96.8%, and 100% in groups A, B, and C, respectively) or adverseevent profiles. Fifteen patients (7.6%) reported adverse events during the study (5 [8.2%] in group A, 6 [9.7%] in group B, and 4 [6.6%] in group C). The adverse events included diarrhea (6 patients), dizziness (5), abdominal pain (2), nausea (1), and skin rash (1). Three patients discontinued treatment because of adverse events ( 1 due to skin rash in group A and 2 due to dizziness in group B). In the 147 patients included in the PP analysis of the effect of CYP2C19 genotype, eradication rates were 88.9% (32/36) in poor metabolizers, 82.0% (50/61) in heterozygous extensive metabolizers, and 82.0% (41/50) in homozygous extensive metabolizers. Eradication rates did not differ significantly among genotype groups. Conclusions: One week of first-line triple therapy with levofloxacin and amoxicillin plus esomeprazole 20 or 40 mg BID or rabeprazole 10 mg BID was associated with H pylori eradication rates of 85.2%, 87.1%, and 75.4%, respectively, with no significant differences between treatment groups. There were no significant differences in eradication of H pylori by CYP2C19 genotype in this small population of Chinese adults. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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