Levofloxacin Triple Therapy Research Articles

Levofloxacin, Metronidazole, and Lansoprazole Triple Therapy Compared to Quadruple Therapy as a Second-Line Treatment ofHelicobacter pyloriInfection in Korea

Background/AimsSeveral rescue therapies have been recommended to eradicate Helicobacter pylori infection in patients with a failure of first-line eradication therapy, but they still fail in more than 20% of cases. The aim of this study was to evaluate the efficacy and safety of levofloxacin, metronidazole, and lansoprazole (LML) triple therapy relative to quadruple therapy as a second-line treatment.MethodsIn total, 113 patients who failed first-line triple therapy for H. pylori infection were randomly assigned to two groups: LML for 7 days and tetracycline, bismuth subcitrate, metronidazole and lansoprazole (quadruple) for 7 days.ResultsAccording to intention-to-treat analysis, the infection was eradicated in 38 of 56 patients (67.9%) in the LML group and 48 of 57 (84.2%) in the quadruple group (p=0.042). Per-protocol analysis showed successful eradication in 38 of 52 patients (73.1%) from the LML group and 48 of 52 (92.3%) from the quadruple group (p=0.010). There were no significant differences in the adverse effects in either treatment group.ConclusionsLML therapy is less effective than quadruple therapy as a second-line treatment for H. pylori infection. Therefore, quadruple therapy should be considered as the primary second-line strategy for patients experiencing a failure of first-line H. pylori therapy in Korea.

Culture-based Selection Therapy for Patients Who Did Not Respond to Previous Treatment for Helicobacter pylori Infection

Eradication of Helicobacter pylori using empiric therapy has become difficult as a result of increasing resistance to antibiotics. We evaluated the efficacy of specific treatments, selected based on response of bacterial samples to culture with clarithromycin, levofloxacin, and metronidazole, for patients infected with resistant strains of H pylori. We performed a prospective study at a single center of 236 consecutive patients with persistent H pylori infection, despite 1 or more treatment attempts, and documented resistance to at least 1 antimicrobial agent (based on bacterial culture tests). Biopsy samples were collected by endoscopy and cultured in selective media. Patients received either 10 days of levofloxacin (250 mg twice daily for 131 patients with susceptible infections) or 12 days of rifabutin (150 mg once daily for 105 patients resistant to levofloxacin) in combination with amoxicillin (1 g twice daily) and esomeprazole (40 mg twice daily). Efficacy of eradication was determined by the (13)C-urea breath test, 6 to 8 weeks after therapy. Compliance and side effects were determined via personal interviews at the end of therapy. Rifabutin toxicity was monitored by analysis of blood samples. H pylori infection was cured in 118 of the patients who received levofloxacin triple therapy (90%; 95% confidence interval, 85%-95%) and 93 of the patients who received rifabutin triple therapy (88.6%; 95% confidence interval, 82%-95%). In each group, the cure rate did not differ significantly between patients infected with H pylori strains resistant to single or multiple antibiotics. Mild side effects occurred in 15.5% and 14.9% of patients resistant to single or multiple antibiotics, respectively, and self-limiting neutropenia was observed in 1 (0.7%) case. Selection of triple therapy with either levofloxacin or rifabutin, based on results from bacterial culture tests, cures H pylori infection in about 90% who did not previously respond to antibiotics.

Levofloxacin‐containing Triple and Sequential Therapy or Standard Sequential Therapy as the First Line Treatment for Helicobacter pylori Eradication in China

To compare the efficacy and the adverse effects of levofloxacin-containing triple therapy, standard sequential therapy, and levofloxacin-containing sequential therapy as first-line treatment for Helicobacter pylori eradication. Three hundred and forty-five naive H. pylori-positive patients were randomized to receive levofloxacin-containing 7-day triple therapy (Levo triple, i.e., esomeprazole, 20 mg, twice daily, amoxicillin, 1 g, twice daily, and levofloxacin, 500 mg, once daily for 7 days, n = 114), standard sequential therapy (SST-10, 5-day esomeprazole, 20 mg, twice daily and amoxicillin, 1 g, twice daily followed by 5-day esomeprazole, 20 mg, twice daily, clarithromycin, 500 mg, twice daily and tinidazole, 500 mg, twice daily for 5 days, n = 115) or levofloxacin-containing sequential therapy (Levo-ST-10, 5-day esomeprazole, 20 mg, twice daily and amoxicillin, 1 g, twice daily for 5 days followed by 5-day esomeprazole, 20 mg, twice daily, levofloxacin, 500 mg, once daily and tinidazole, 500 mg, twice daily, n = 116). Eradication was confirmed by a (13) C-urea breath test 4 weeks after completion of treatment. Intention to treat (ITT) eradication rates were 78.1% (95% CI: 69.4, 85.3%), 78.3% (95% CI: 69.6, 85.4%), and 82.8% (95% CI: 74.6, 89.1%) for Levo triple, SST-10, Levo-ST-10, respectively (p = .599). Per protocol (PP) eradication rates were 80.9% (95% CI: 72.3, 87.8%), 82.6% (95% CI: 74.1, 89.2%), and 86.5% (95% CI: 78.7, 92.2%), respectively, for the three therapies (p = .513). Overall, 3.8% experienced mild to moderate adverse events; the rates were 1.75, 4.35, and 5.17%, respectively, in the three groups (p = .325). Standard sequential therapy and 7-day levofloxacin triple therapy produced unacceptably therapeutic efficacy in China. Only levofloxacin-containing sequential therapy achieved borderline acceptable result. None of the regimens tested reliably achieved 90% or greater therapeutic efficacy in China.

Su1695 Levofloxacin, Metronidazole and Lansoprazole Triple Therapy Compared to Quadruple Therapy as a Second Line Treatment of Helicobacter pylori Infection

Su1695 Levofloxacin, Metronidazole and Lansoprazole Triple Therapy Compared to Quadruple Therapy as a Second Line Treatment of Helicobacter pylori Infection

Impact ofLactobacillus reuteriSupplementation on Anti-Helicobacter pyloriLevofloxacin-Based Second-Line Therapy

Introduction. Helicobacter pylori eradication therapy has the potential burden of antibiotic-associated gastrointestinal (GI) side effects. The occurrence of side effects is among the major drawbacks of such regimens. GI manifestations may be related to alterations in the intestinal microflora. Probiotics can prevent or reduce antibiotic-associated side effects and have an inhibitory effect on H. pylori. Methods. To define the efficacy of Lactobacillus reuteri supplementation in H. pylori eradication and in preventing GI-associated side effects during a second-line levofloxacin triple therapy. 90 H. pylori-positive patients receive for 7 days a second-line triple therapy with esomeprazole, levofloxacin, and amoxicillin with L. reuteri for 14 days (group 1) and without probiotic supplementation (group 2). Each subject received a validated questionnaire to record symptoms everyday for 4 weeks from the start of therapy. H. pylori status and side effects were assessed 6 weeks after treatment. Results. The eradication rate was significantly influenced by probiotic supplementation with L. reuteri (group 1: 36/45, 80%; group 2: 28/45 62%; P < 0.05). The incidence of nausea and diarrhoea in group 1 was significantly lower than that in group 2. Conclusion. In H. pylori-positive subjects L. reuteri supplementation increases the eradication rate while reducing the incidence of the most common side effects associated with antibiotic therapy in second-line treatment.

A Randomized Comparative Study of Levofloxacin Based Triple Therapy with Standard Triple Therapy for Helicobacter pylori Eradication

Helicobacter pylori are associated with peptic ulcer disease, gastritis and malignancy. Eradication of Helicobacter pylori in patient with peptic ulcer greatly reduces the rate of relapse. Hence, it is vital to find the ideal regimen. Primary antibiotic resistance and poor compliance attribute to eradication failure of standard regimens. This study investigated the eradication rate, patient compliance, tolerability and side effects profile of a one week, once daily levofloxacin plus azithromycin triple therapy versus standard twice daily triple therapy. A prospective, randomized, comparative study, enrolling 72 Helicobacter pylori positive patients, with dyspeptic symptoms was done. These patients were randomized either to the esomeprazole 20 mg, levofloxacin 500mg, and azithromycin 500mg, once daily (ELA Group) or esomeprazole 20mg, clarithromycin 500mg and amoxicillin 1 gm twice daily (ECA group) for 1 week. Helicobacter pylori infection was defined by rapid urease test and histology, both at the entry, as well as at the end of the study. Helicobacter pylori eradication rates of ELA and ECA group were similar (67.6% and 77.1% respectively, p=0.337). Both the treatment groups were similar in terms of compliance (p=0.721) and tolerability (p=0.963). No significant differences were noted in the incidence of side effects between the two treatment groups (p=0.253). Once daily, levofloxacin plus azithromycin-based triple therapy may represent a promising alternative to the standard twice daily triple therapy.

Efficacy and safety of Levofloxacin, Clarithromycin and Esomeprazol as first line triple therapy for Helicobacter pylori eradication in Middle East. Prospective, randomized, blind, comparative, multicenter study

Background/aims Antibiotic resistance and poor compliance are the main causes of Helicobacter pylori ( H. pylori ) eradication failure. This study evaluated the eradication rate, tolerability, and compliance of Levofloxacin, Clarithromycin and Esomeprazol combined triple therapy for H. pylori eradication. Patients and methods Four hundred-fifty patients from 3 centres who were diagnosed to have Helicobacter pylori infection by 13C-urea breath test were randomized into 3 equal groups; group 1 (CAE) received Clarithromycin 500 mg twice daily, Amoxicillin 1000 mg twice daily, plus Esomeprazol 20 mg twice daily for 7 days, group 2 (LAE) received Levofloxacin 500 mg once daily, Amoxicillin 1000 mg twice daily, plus Esomeprazol 20 mg twice daily for 7 days, group 3 (CLE) received Levofloxacin 500 mg once daily, Clarithromycin 500 mg twice daily, plus Esomeprazol 20 mg twice daily for 7 days. 436 patients were re-evaluated by 13C-urea breath test after 6 weeks from completion of treatment. Results H. pylori eradication (intention to treat) was successful in 136/150 (90.6%) with CLE, 127/150 (84.7%) with LAE and 118/150 (78.6%) with CAE. There was a significant difference ( p < 0.001) regarding treatment success between CLE and LAE when compared with CAE. There was no difference among the treatment groups with regard to the incidence and severity of adverse events reported. Conclusion The combined Levofloxacin, and Clarithromycin and Esomeprazol based regimen as first line triple therapy for H. pylori eradication can give more significant eradication rate with same safety when compared with classic triple therapy.

Emerging Therapies for the Treatment of Helicobacter pylori Infections

To describe emerging therapies, such as levofloxacin, moxifloxacin, rifabutin, rifaximin, tinidazole, doxycycline, minocycline, lactoferrin, and plaunotol for the eradication of Helicobacter pylori infection. Relevant information was identified through a search of MEDLINE (1966-July 2008), PubMed (1955-July 2008), American Search Premier (1975-July 2008), International Pharmaceutical Abstracts (1960-2008), Science Citation Index Expanded (1996-2008), Cochrane Databases (publications archived until July 2008), and various tertiary sources using the terms Helicobacter pylori, fluoroquinolones, levofloxacin, moxifloxacin, rifabutin, rifaximin, lactoferrin, plaunotol, tinidazole, doxycycline, minocycline, faropenem, new treatments, refractory, and salvage alone or in combination. Relevant information was identified and selected based on clinical relevance and value of information. In vitro and in vivo data were included if available. Data exist supporting the use of levofloxacin or rifabutin as salvage therapies for H. pylori infection. Levofloxacin triple therapy has been recommended in the current treatment guideline, but more data are needed, especially from studies conducted in the US. A rifabutin-based regimen is better tolerated than conventional quadruple therapy, but its use is limited due to cost, hematologic adverse effects, drug interactions, and predicted development of resistance. Tinidazole appears to be an option, particularly as sequential therapy when combined with other agents; however, its use is limited by the high prevalence of nitroimidazole-resistant H. pylori strains in the US. Moxifloxacin data are limited. Data supporting the use of rifaximin, doxycycline, and minocycline are lacking or do not show benefit of these drugs over standard treatments. H. pylori infection remains one of the most significant infections worldwide, and treatment failure rate with the current standard therapy continues to rise. Other treatment options should be explored to meet the emerging challenge.

Levofloxacin and rebeprazole-based triple regimen therapy for 94 cases of Helicobacter pylori infection

Levofloxacin and rebeprazole-based triple regimen therapy for 94 cases of <i>Helicobacter pylori</i> infection

Clinical trial: levofloxacin‐based quadruple therapy was inferior to traditional quadruple therapy in the treatment of resistant Helicobacter pylori infection

The efficacy of levofloxacin-based quadruple therapy in resistant Helicobacter pylori infection is not known. To test the efficacy of levofloxacin-based quadruple therapy and traditional quadruple therapy in resistant H. pylori infection. One hundred and two patients with resistant H. pylori infection were randomized to 1 week of either EBAL (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., amoxicillin 1 g b.d. and levofloxacin 500 mg b.d.) or EBMT (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., metronidazole 400 mg t.d.s. and tetracycline 500 mg q.d.s.). (13)C-urea breath test was performed at week 12 to assess post-treatment H. pylori status. In intention-to-treat analysis H. pylori eradication was achieved in 37 of 51 (73%) subjects in EBAL and 45 of 51 (88%) subjects in EBMT groups, respectively (P = 0.046). Per-protocol eradication rates of EBAL and EMBT groups were 78% and 94%, respectively (P = 0.030). The intention-to-treat eradication rate was statistically lower for EBAL than EMBT (56% vs. 90%, P = 0.013) among those who had failed more than one course of eradication therapy. Previous levofloxacin triple therapy did not affect the efficacy of either protocol significantly. Levofloxacin-based quadruple therapy was inferior to traditional quadruple therapy for resistant H. pylori infection.

Levofloxacin-Based Triple Therapy versus Bismuth-Based Quadruple Therapy for Persistent Helicobacter pylori Infection: A Meta-Analysis. CME

Levofloxacin-based triple therapy has been suggested as an alternative salvage therapy to bismuth-based quadruple therapy for persistent Helicobacter pylori (H. pylori) infection. A search of PUBMED, EMBASE, EBM Review databases and abstracts from recent Digestive Disease Week, United European Gastroenterology Week, and European Helicobacter Study Group conferences was performed. Randomized controlled trials (RCTs) comparing levofloxacin-based triple salvage therapy (levofloxacin + amoxicillin + PPI) to bismuth-based quadruple salvage therapy (bismuth + tetracycline + metronidazole + PPI) were selected for meta-analysis. Additionally, all prospective trials evaluating this levofloxacin-based triple therapy as salvage therapy were pooled to analyze optimal levofloxacin treatment duration and dosing. All selected trials confirmed prior treatment failure and post-salvage treatment eradication. Four RCTs compared a 10-day regimen of levofloxacin-based triple therapy to 7-day bismuth-based quadruple therapy (n = 391 patients). Levofloxacin-based triple therapy was superior to quadruple therapy (RR = 1.41 [95% CI: 1.25-1.59]). Levofloxacin-based triple therapy was better tolerated than quadruple therapy with a lower incidence of side effects (RR = 0.51 [95% CI: 0.34-0.75]) and side effects prompting discontinuation of therapy (RR = 0.30 [95% CI: 0.10-0.89]). Eleven trials (n = 547 patients) evaluating levofloxacin-based triple therapy demonstrated higher eradication rates with 10-day versus 7-day regimen (87%[95% CI: 82%-92%]vs 68%[95% CI: 62%-74%]) yet eight trials (n = 477 patients) demonstrated no difference with 500 mg daily versus 250 mg b.i.d. dosing of levofloxacin (81%[95% CI: 78%-89%]vs 84%[95% CI: 66%-97%]). A 10-day course levofloxacin triple therapy is more effective and better tolerated than 7-day bismuth-based quadruple therapy in the treatment of persistent H. pylori infection.

7‐Day Triple Therapy of Helicobacter pylori Infection with Levofloxacin, Amoxicillin, and High‐Dose Esomeprazole in Patients with Known Antimicrobial Sensitivity

Failed primary anti-Helicobacter pylori therapy results in a high rate of antimicrobial resistance. This necessitates a search for new regimens to cure H. pylori infection. The aim of this study was to evaluate the efficacy and tolerability of a new levofloxacin-containing 7-day triple therapy and to compare it with that of standard French triple therapy in patients with known H. pylori susceptibility to MET (metronidazole) and CLA (clarithromycin). Sixty-one patients with documented antibiotic sensitivity (E-test) and an indication for anti-H. pylori treatment based on the Maastricht Consensus 2/2000 guidelines were randomized to receive either esomeprazole 2 x 40 mg, levofloxacin 2 x 500 mg, and amoxicillin 2 x 1 g for 7 days (ELA, n = 30), or esomeprazole 2 x 20 mg, clarithromycin 2 x 500 mg, and amoxicillin 2 x 1 g for 7 days (ECA, n = 31). A cure check was performed 4-6 weeks after conclusion of therapy. Sixty-one patients were randomized to the two treatment groups. Twenty-eight of 30 patients of the ELA group were available for per-protocol (PP) analysis, of whom 26 (92.9% CI: 76-99%; intention-to-treat [ITT] analysis 86.7% CI: 68-96%) became H. pylori negative compared with 26 of the 31 patients of the ECA group (83.9%, CI: 66-93% both PP and ITT analyses). Five patients of the ELA group showed CLA resistance, three of whom also showed MET resistance, and all five were treated successfully. Two patients with levofloxacin-resistant strains, one in each group, were cured. Both regimens were generally well tolerated with minor adverse events being seen in 15 patients (51.7%) of the ELA group and in 13 (40.6%) of the ECA group. None of the patients discontinued treatment prematurely due to adverse events. The data of this pilot study suggest a better than 80% efficacy of the new 7-day levofloxacin triple therapy, which is within the range of the French triple therapy in patients with MET- and CLA-susceptible strains. The data suggest that the new levofloxacin triple therapy may also be an option in patients with MET- and CLA-resistant H. pylori strains.

Lansoprazole, levofloxacin and amoxicillin triple therapy vs. quadruple therapy as second‐line treatment of resistant Helicobacter pylori infection

To test the efficacy of levofloxacin-based second-line therapy for resistant Helicobacter pylori infection. One hundred and six patients who failed H. pylori eradication were randomized to receive (i) lansoprazole 30 mg, amoxicillin 1 g, levofloxacin 500 mg, all given twice daily for 7 days (LAL); or (ii) lansoprazole 30 mg twice daily, metronidazole 400 mg thrice daily, bismuth subcitrate 120 mg and tetracycline 500 mg four times daily for 7 days (quadruple). Post-treatment H. pylori status was determined by (13)C-urea breath test. Intention-to-treat and per-protocol H. pylori eradication rates were 57/60% for the LAL group and 71/76% for the quadruple group respectively. Metronidazole, clarithromycin, amoxicillin and levofloxacin resistance were found in 76%, 71%, 0% and 18% of patients, respectively. Levofloxacin resistance led to treatment failure in the LAL group. For patients with dual resistance to metronidazole and clarithromycin, the eradication rates were 79% in the LAL group (levofloxacin-sensitive) and 65% in the quadruple group (P=0.34). Lansoprazole, amoxicillin plus levofloxacin second-line therapy is comparable with quadruple therapy in efficacy. Subjects, especially those with dual resistance to metronidazole and clarithromycin, may consider levofloxacin-based therapy for levofloxacin-sensitive strains.

One-week once-daily triple therapy with esomeprazole, levofloxacin and azithromycin compared to a standard therapy for Helicobacter pylori eradication

Background. Primary antibiotic-resistance and poor compliance are the main causes of Helicobacter pylori eradication failure of standard regimens. Aim. To investigate eradication rate, patient compliance and tolerability of a 1-week once-daily levofloxacin plus azithromycin triple therapy versus the standard twice-daily triple therapy. Patients and methods. A total of 164 H. pylori-positive patients were randomised to either esomeprazole 20 mg, levofloxacin 500 mg and azithromycin 500 mg once-daily (ELAz) or esomeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1 g twice-daily (ECA) for 1 week. H. pylori infection was defined at entry by histology and urea breath test; cure of infection was determined both by negative urea breath test and H. pylori stool antigens. Results. H. pylori eradication rates of ELAz and ECA were similar at intention-to-treat (both 65%) and per-protocol analyses (70% versus 76%, respectively). Incidence of poor compliance was lower, although not significantly, in patients randomised to ELAz than to ECA (4% versus 10%); tolerability was significantly higher for ELAz than for ECA (88% versus 70%; P = 0.01). Conclusions. Once-daily levofloxacin plus azithromycin-based triple therapy achieves an H. pylori eradication rate comparable to that of standard twice-daily triple therapy, but is associated with higher patient compliance and might even be better tolerated.