Levofloxacin-based sequential therapy versus classic triple therapy in Helicobacter pylori eradication: A randomized clinical trial (original) (raw)
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Levofloxacin-Based Triple Therapy in First-Line Treatment for Helicobacter pylori Eradication
The American Journal of Gastroenterology, 2006
BACKGROUND: The standard first-line therapies for Helicobacter pylori eradication are based on clarithromycin and amoxicillin or metronidazole. Recent studies suggested levofloxacin as an alternative option for both first-and second-line H. pylori eradication treatment. AIMS: To compare efficacy and tolerability of two different 7-day standard triple therapies versus 7-day levofloxacin-based triple therapy in first-line treatment for H. pylori infection. METHODS: Three hundred consecutive H. pylori positive patients were randomized to receive: clarithromycin, amoxicillin, esomeprazole (Group A: N = 100); clarithromycin, metronidazole, esomeprazole (Group B: N = 100); or clarithromycin, levofloxacin, esomeprazole (Group C: N = 100). H. pylori status was rechecked by 13 C urea breath test 6 wk after the end of therapy. RESULTS: Sixteen out of 300 patients discontinued treatment because of the occurrence of side effects (Group A, 5; Group B, 7; Group C, 4). The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 75% and 79%; Group B, 72% and 77.4%; and Group C, 87% and 90.6%. The eradication rate achieved with levofloxacin-based triple therapy was significantly higher than that with standard therapies in either ITT (87% vs 75%, p <0.05; 87% vs 72%, p <0.01;) or PP analysis (90.6% vs 79%, p <0.05; 90.6 vs 77.4, p <0.05). No difference was found between standard triple therapies. The incidence of side effects was similar among groups. CONCLUSIONS: A 7-day levofloxacin-based triple therapy can achieve higher H. pylori eradication rates than standard regimens. These data suggest levofloxacin-based regimens can be the most effective in first-line anti-H. pylori therapy, at least in the Italian population.
European Journal of Internal Medicine, 2012
Background: There is an important concern about the success of standard triple treatment for Helicobacter pylori (H. pylori) in recent years. Better eradication rates have been reported with sequential treatment in current studies. This study aimed to compare the success of a novel levofloxacin-containing sequential regimen with standard triple therapy. Methods: H. pylori-positive patients with non-ulcer dyspepsia were randomly allocated to one of the study groups. The patients on sequential arm were given esomeprazole 40 mg BID and amoxicillin 1 g BID for the first week followed by esomeprazole 40 mg BID, levofloxacin 500 mg QD and metronidazole 500 mg TID for the second week. The patients on standard triple arm were given esomeprazole 40 mg BID, amoxicillin 1 g BID and clarithromycin 500 mg BID for 2 weeks. Eradication was assessed by urea breath test on 6th weeks. Results: Seventy-five patients were enrolled in each group; 72 in sequential arm and 67 in standard arm completed the protocols. H. pylori eradication rate of per protocol was 90% in sequential versus 57% in standard treatment groups with a statistical significance (p b 0.000). Both regimens were similarly well tolerated and side effects were comparable. Only one patient in sequential arm stopped the treatment because of side effects. Conclusion: The levofloxacin-containing sequential therapy is a significantly better strategy than the standard triple treatment for H. pylori eradication. Standard triple treatment is no more effective for H. pylori in our population and levofloxacin-containing sequential regimen might be used as a first-line eradication option.
Alimentary Pharmacology and Therapeutics, 2003
Background: Levofloxacin has been shown to be effective in Helicobacter pylori eradication. Two 10-day levofloxacin-based triple therapies were compared with standard 7-and 14-day quadruple regimens in second-line treatment. Methods: Two hundred and eighty consecutive patients who failed to respond to standard triple therapy (clarithromycin, amoxicillin, rabeprazole) were randomly assigned to four groups: (1) levofloxacin 500 mg o.d., amoxicillin 1 g b.d., rabeprazole 20 mg b.d. for 10 days (LAR, n ¼ 70); (2) levofloxacin 500 mg o.d., tinidazole 500 mg b.d., rabeprazole 20 mg b.d. for 10 days (LTR, n ¼ 70); (3) tetracycline 500 mg q.d.s., metronidazole 500 mg t.d.s., bismuth salt 120 mg q.d.s., rabeprazole 20 mg b.d. for 7 days (7TMBR, n ¼ 70); and (4) for 14 days (14TMBR, n ¼ 70). Helicobacter pylori status and side-effects were assessed 6 weeks after treatment. Results: The eradication rate was 94% in the LAR group and 90% in the LTR group in both intention-to-treat and per protocol analyses. Helicobacter pylori eradication was achieved in 63 and 69% of the 7TMBR group and in 69 and 80% of the 14TMBR group in intention-totreat and per protocol analysis, respectively. Side-effects were significantly lower in the LAR and LTR groups than in the 14TMBR group. Conclusion: Ten-day levofloxacin-based therapies are better than standard quadruple regimens as second-line option for H. pylori eradication.
PLoS ONE, 2014
Quinolone has the disadvantage of easily acquired drug resistance. It is important to prescribe it wisely for a high eradication rate. The current study aimed to determine the clinical and bacteriological factors for optimal levofloxacincontaining triple therapies in second-line H. pylori eradication. We enrolled a total of 158 H. pylori-infected patients who failed H. pylori eradication using the 7-day standard triple therapy (proton-pump inhibitor [PPI] twice daily, 500 mg clarithromycin twice daily, and 1 g amoxicillin twice daily). They were prescribed with either a 10-day (group A) or 14-day (group B) levofloxacin-containing triple therapy group (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily for 10 days) by their clinicians. Follow-up studies to assess treatment responses were carried out 8 weeks later. The eradication rates attained by groups A and B were 73.6% (95% confidence interval [CI] = 63.9-85.3%) and 90.5% (95% CI = 84.5-98.1%), respectively in the per protocol analysis (P = 0.008 in the per protocol analysis) and 67.1% (95% CI = 56.6-78.5%) and 84.8% (95% CI = 76.8-93.4%), respectively, in the intention-to-treat analysis (P = 0.009). The subgroup analysis revealed that H. pylori eradication rates for group A patients with levofloxacin-susceptible strains were 92.9% (13/14) but it dropped to 12.5% (1/8) when levofloxacin-resistant strains existed. H. pylori was eradicated among all the group B patients with levofloxacin-susceptible strains, but only half of patients with levofloxacin-resistant strains were successfully eradicated. In conclusion, this study confirms the effectiveness of 14-day treatment. Importantly, the results imply that 10-day treatment duration should be optimal if a culture can be performed to confirm the existence of susceptible strains. The duration of H. pylori eradication and levofloxacin resistance were the influencing factors for successful treatment. This study suggests that tailored levofloxacin-containing therapy should be administered only for patients with susceptible strains because it can achieve .90% success rates.
Annals of gastroenterology : quarterly publication of the Hellenic Society of Gastroenterology, 2014
Helicobacter pylori (H. pylori) treatment remains a challenge for physicians. Although highly effective, the standard sequential therapy fails in a certain number of patients. Moreover, the cure rate following a levofloxacin-amoxicillin second-line triple therapy seems to be decreasing. We tested the efficacy of modified 10-day sequential therapy, and an intensified levofloxacin-amoxicillin regimen as first- and second-line therapy respectively. In this prospective, open label, multicenter, pilot study H. pylori-infected patients received a first-line modified 10-day sequential therapy regimen including rabeprazole 20 mg, and amoxicillin 1 g for the first 3 days, followed by rabeprazole 20 mg, clarithromycin 250 mg, and metronidazole 250 mg, for the remaining 7 days, all drugs given thrice daily. An 8-day therapy regimen with rabeprazole 20 mg, levofloxacin 250 mg, and amoxicillin 1 g, all thrice daily, was administered a second-line therapy. A total of 99 and 15 patients were enrol...
The Efficacy of Levofloxacin-based Triple Therapy for First-line Helicobacter Pylori Eradication
Medical Archives, 2013
I ntroduction: Because of the increasing resistance to clarithromycin and metronidazole, new therapeutic alternatives are needed. The purpose of this study was to compare the efficacy of 7and 10-day triple therapy including omeprazole, levofloxacin and amoxicilline for Helicobacter pylori eradication as a first-line therapy. Methods: One hundred and five patients with peptic ulcer disease and with non-ulcer dyspepsia infected with Helicobacter pylori were included in this study. Patients were randomized to receive either 7-day or 10-day therapy with omeprazole (20 mg b.i.d.), plus levofloxacin (500 mg o.i.d.) and amoxicilline (1000 mg b.i.d.). Eradication was assessed by negative histological analyses, negative H. pylori stool antigen or rapid urease test. Results: In Group 1, the eradication rate was 86, 2%, while in group 2, eradication rate was 93, 6%. There was no difference between groups (p=0.218). Adverse effects were reported in 5, 25% of the patients, including nausea and diarrhea. Conclusions: The levofloxacin-based regimen can be one effective therapy for the first-line anti-H. pylori treatment. However, a levofloxacin-based triple therapy is not generally recommended as first-line therapy at the moment due to concerns about the rising prevalence of quinolone-resistant strains in the first-line and second-line anti-H. pylori therapies.
Digestive and Liver Disease, 2003
Background. Successful eradication of Helicobacter pylori infection after failure of standard triple therapy is difficult. The efficacy and safety of levofloxacin based triple therapy as a first-line therapy has been studied. Aims. The aim was to evaluate the efficacy and tolerability of levofloxacin based therapy after a failed standard triple therapy. Patients. We conducted a prospective, uncontrolled study of a consecutive series of 33 patients who failed eradication with 1 week of lansoprazole-amoxicillin-clarithromycin triple therapy. Methods. The subjects were retreated with 1 week of LA-LVFX triple therapy (lansoprazole, 30 mg twice daily; amoxicillin, 1000 mg twice daily; levofloxacin, 200 mg twice daily). Cure of infection was defined as negative results from culture, histology and a urea breath test 4 to 8 weeks after the second-line therapy. Results. The eradication rate was 69.7% (23 / 33) by both intention-to-treat and per-protocol analyses (95% confidence interval561-79%). Seven (21.2%) patients experienced mild side-effects, such as soft stools and taste disturbance. No patient stopped the medication on account of adverse effects. Conclusions. Levofloxacin based triple therapy is an effective second-line treatment after a failed standard triple therapy.
Journal of Antimicrobial Chemotherapy, 2012
Background: There is growing evidence that the standard triple therapy against Helicobacter pylori infection is losing clinical effectiveness. A triple therapy regimen with levofloxacin, amoxicillin and a proton pump inhibitor has been reported to be effective and well tolerated, and this regimen has been suggested as an alternative first-line treatment. The aim of this single-blind randomized clinical trial was to compare the eradication success of two first-line triple therapy regimens in the north of Spain: clarithromycin, amoxicillin and omeprazole (CAO) versus levofloxacin, amoxicillin and omeprazole (LAO).
Gut, 2010
Background and aims Antimicrobial drug resistance is a major cause of the failure of Helicobacter pylori eradication and is largely responsible for the decline in eradication rate. Quadruple therapy has been suggested as a first-line regimen in areas with clarithromycin resistance rate >15%. This randomised trial aimed at evaluating the efficacy of a levofloxacin-containing sequential regimen in the eradication of H pylori-infected patients in a geographical area with >15% prevalence of clarithromycin resistance versus a clarithromycincontaining sequential therapy. Methods 375 patients who were infected with H pylori and naïve to treatment were randomly assigned to one of the following treatments: (1) 5 days omeprazole 20 mg twice daily + amoxicillin 1 g twice daily followed by 5 days omeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + tinidazole 500 mg twice daily; or (2) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily followed by omeprazole 20 mg twice daily + levofloxacin 250 mg twice daily + tinidazole 500 mg twice daily; or (3) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily followed by omeprazole 20 mg twice daily + levofloxacin 500 mg twice daily + tinidazole 500 mg twice daily. Antimicrobial resistance was assessed by the E-test. Efficacy, adverse events and costs were determined for each group. Results Eradication rates in the intention-to-treat analyses were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9% to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between groups. Levofloxacin-250 therapy was cost-saving compared with clarithromycin sequential therapy. Conclusion In an area with >15% prevalence of clarithromycin resistant H pylori strains, a levofloxacincontaining sequential therapy is more effective, equally safe and cost-saving compared to a clarithromycincontaining sequential therapy.
Seven-day PPI-triple therapy with levofloxacin is very effective for Helicobacter pylori eradication
The Netherlands Journal of Medicine
Helicobacter pylori infection causes lifelong gastritis and is associated with the development of peptic ulcer disease, MAlT lymphoma and gastric cancer. Many patients benefit from H. pylori eradication therapy. PPi-triple therapy is recommended as initial therapy. Quadruple therapy, with a PPi, bismuth, and two antibiotics, used to be recommended as second-line therapy, but can no longer be prescribed because bismuth is no longer available. Therefore, there is an urgent need for new effective rescue therapies. levofloxacin-based therapies were suggested as an alternative to quadruple therapy. The aim of this study is to examine the efficacy and tolerability of such a one-week therapy with levofloxacin and esomeprazole combined with either amoxicillin or clarithromycin in a dutch population. Methods: between february 2005 and November 2006, 123 consecutive H. pylori positive patients were enrolled in this study. The first 59 patients were treated with esomeprazole, amoxicillin and levofloxacin (group i). The next 64 patients were treated with esomeprazole, clarithromycin, and levofloxacin (group ii). both therapies were compared for efficacy and tolerability. results: in group i the overall (iTT) cure rate was 96% and in group ii it was 93%. Minor side effects occurred in 29% of patients in group i and in 41% of patients in group ii. Major side effects that warranted discontinuation of therapy occurred in two patients in group ii. Conclusion: seven-day triple therapy with esomeprazole, levofloxacin and either amoxicillin or clarithromycin for seven days is very effective and safe for H. pylori eradication. The combination with amoxicillin seems to be better tolerated than the combination with clarithromycin.