Triple Therapy with Lansoprazole, Clarithromycin, and Amoxicillin for the Cure of Helicobacter pylori Infection: A Short Report

Background Given the therapeutic potential of proton pump inhibitor-based triple therapy for successful cure of Helicobacter pylori infection, we evaluated the efficacy and safety of lansoprazole with clarithromycin and amoxicillin in an open-label, single-center study.
Materials and Methods. H. pylori -positive patients self-administered lansoprazole, 30 mg; clarithromycin, 500 mg; and amoxicillin, 1 gm bid for 14 days. Patients were assessed pretreatment, at which time the presence of H. pylori was documented by rapid urease test, culture, or histology, following study drug administration (week 2) for a brief evaluation only, and at least 4 weeks posttreatment (week 6), which included endoscopy with collection of biopsy specimens for culture and histology testing.
Results. Primary clarithromycin and metronidazole resistance were observed in 6% (2 of 30) and 43% (13 of 30) of study patients, respectively. One month after the end of therapy, H. pylori infection was cured in 23 of 25 patients (92%; 95% confidence interval, 74%-99%). The triple-therapy regimen was well-tolerated; 17% of patients (5 of 30) reported mild to moderate adverse effects during the treatment period.
Conclusion. A 2-week, triple-drug combination of lansoprazole, clarithromycin, and amoxicillin is highly effective for cure of H. pylori infection. Additionally, the triple-drug combination was well-tolerated by patients infected with H. pylori.     

Double-Blind, Multicenter Evaluation of Lansoprazole and Amoxicillin Dual Therapy for the Cure of Helicobacter pylori Infection

Background Treatment with amoxicillin plus omeprazole results in disappointing cure rates of Helicobacter pylori infection. The minimal inhibitory concentration of lansoprazole for H. pylori in vitro is lower than that for omeprazole, prompting interest in treatment with amoxicillin plus lansoprazole.
Materials and Methods. H. pylori -infected patients with endoscopically documented duodenal ulcer either currently or within the past year were randomized to 14 days of (1) lansoprazole, 30 mg bid, plus amoxicillin, 1 gm tid; (2) lansoprazole, 30 mg tid, plus amoxicillin, 1 gm tid; (3) lansoprazole, 30 mg tid alone; or (4) amoxicillin, 1 gm tid alone. Endoscopy was done at enrollment and at 4 to 6 weeks after completion of treatment or for recurrent symptoms. H. pylori status was assessed by culture and histology. Ulcer prevalence was evaluated at follow-up endoscopy.
Results. Two hundred sixty-two patients met enrollment criteria and were treated. By per-protocol analysis, H. pylori infection was cured in 57% of those treated with lansoprazole twice daily plus amoxicillin and in 67% of those treated with lansoprazole three times daily plus amoxicillin, compared with 0% treated with lansoprazole alone or amoxicillin alone ( p < .001 for dual therapy versus either monotherapy). Amoxicillin resistance was not observed. At follow-up endoscopy, ulcer prevalence was 17% in patients treated with lansoprazole twice daily plus amoxicillin, 23% in those treated with lansoprazole three times daily plus amoxicillin, 33% in those treated with lansoprazole alone, and 35% in those treated with amoxicillin alone ( p = .024; lansoprazole twice daily plus amoxicillin versus amoxicillin alone).
Conclusions. Treatment with amoxicillin plus lansoprazole, 30 mg tid, led to cure of H. pylori infection in 67% of patients with active or recently healed duodenal ulcer.     

Impact of Quadruple Regimen of Clarithromycin Added to Metronidazole-Containing Triple Therapy Against Helicobacter pylori Infection Following Clarithromycin-Containing Triple-Therapy Failure

Background: The establishment of an optimal second-line regimen for Helicobacter pylori infection is required. Although quadruple therapy should overcome resistance to either clarithromycin or metronidazole, the effects of a quadruple regimen in second-line therapy are unknown. This study aims to evaluate the efficacy of triple therapy composed of proton pump inhibitor/amoxicillin plus metronidazole with the combined additive effects of clarithromycin as a second-line quadruple therapy against H. pylori infection.
Materials and Methods: Participants were 104 patients in whom first-line therapy containing proton pump inhibitor-amoxicillin-clarithromycin failed. Before starting second-line therapy, patients underwent endoscopy to obtain H. pylori strain for antibiotic susceptibility tests. Patients were randomized to receive rabeprazole (10 mg), amoxicillin (750 mg), and metronidazole (250 mg), either with clarithromycin (200 mg; RAMC group) or without (RAM group); all treatments were administered twice daily for 7 days. H. pylori eradication was confirmed by ¹³C-urea breath tests performed 2 to 3 months post-therapy.
Results: As shown by intention-to-treat/per-protocol analyses, the cure rates for H. pylori infection were 88.5%/93.9% and 82.7%/84.3% for the RAMC and RAM groups. Although the study probably had an insufficient power to show a significant difference between the cure rates of the two regimens, the eradication rates showed a clear trend in favor of the RAMC group. There were no severe side-effects in any group.
Conclusions: In Japan, the RAMC regimen is thought to be a promising alternative strategy for second-line eradication of H. pylori infection.     

Effectiveness of Quadruple Therapy Using Lansoprazole, Instead of Omeprazole, in Curing Helicobacter pylori Infection

Background. Omeprazole enhances the efficacy of bismuth-based triple therapy. It is unknown whether the same is true for other proton pump inhibitors. Lansoprazole has superior anti- Helicobacter activity in vitro and possibly also in vivo; therefore we investigated quadruple therapy with lansoprazole.
Materials and Methods. In two studies performed in separate hospitals, a total of 67 Helicobacter pylori –positive patients were treated with 7-day quadruple therapy (lansoprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole) after 3 days of lansoprazole pretreatment. Testing for cure was done by endoscopy in study 1 and by breath test in study 2.
Results. Cure rates per protocol were 31 of 31 (100%) in study 1 and 30 of 32 (94%) in study 2. Intention-to-treat cure rates were 31 of 35 (89%) in study 1 and 30 of 32 (94%) in study 2. Cured overall were 32 of 34 with a metronidazole sensitive strain and 3 of 3 with a metronidazole-resistant strain. Data on side effects were collected from 51 patients. Twelve (21%) had no side effects, 27 (53%) had mild side effects, 10 (20%) had moderate side effects, but only 2 (4%) had severe side effects. Side effects, never were the reason that a patient stopped taking the medication.
Conclusions. The results with lansoprazole-quadruple therapy are comparable to the historic control group treated with omeprazole-quadruple therapy. The cure rate is very high, and although mild to moderate side effects occured in many patients, everybody finished the treatment regime.     

Comparison of One or Two Weeks of Lansoprazole, Amoxicillin, and Clarithromycin in the Treatment of Helicobacter pylori

Background The simplest, most effective, and least expensive Helicobacter pylori therapy remains to be determined. Two weeks of 30 mg lansoprazole bid, 1 gm amoxicillin bid, and 500 mg clarithromycin bid (LAC2) had been shown to be an effective therapy for H. pylori. The aim of this study was to assess whether 1 week of this regimen (LAC1) would have a similar efficacy.
Materials and Methods. H. pylori -positive patients assessed histologically, by rapid urease test, microbiologically, and by a ¹³C-urea breath test (¹³C-UBT) were randomized to receive either LAC1 or LAC2 in a single-center open study. Patients were interviewed 1 to 3 days after completion of therapy to evaluate adverse events and compliance. Efficacy was determined by ¹³C-UBT at least 4 weeks after antibiotic therapy.
Results. Seventy evaluable patients were randomized to receive LAC1 (n = 33) and LAC2 (n = 37). Of the 33 LAC1 patients, 30 (91%) were treated successfully (95% confidence interval (CI) = 76–98%), compared with 32 of 37 (86%) in the LAC2 group (95% CI = 71–96%). There was no difference in efficacy between the two groups (Fisher's exact test p = 1.0; 95% CI =–10.3%–19.2%). Patients taking LAC1 experienced significantly fewer severe adverse events than those taking LAC2 (Mann-Whitney U test). One of 64 patients had primary resistance to clarithromycin, and treatment was unsuccessful in this case. Six of the 7 remaining treatment failures developed secondary resistance to clarithromycin.
Conclusions. LAC1 is as effective as LAC2 and is associated with less toxicity. Posttreatment clarithromycin resistance is common in patients who do not experience success with therapy.     

Miconazole Gel Increases the Cure Rate of Helicobacter pylori Infection When Added to Lansoprazole and Amoxicillin in a Randomized Trial

Background. Miconazole is an antimycotic agent with bacteriocidal activity against Helicobacter pylori in vitro. Its role in the clinical eradication of H. pylori has not been studied. The objective of this study was to investigate the efficacy and side effect profile of miconazole for the treatment of H. pylori.
Materials and Methods. We studied 65 patients with gastritis or peptic ulcer disease in whom H. pylori infection was confirmed by a rapid urease test and microbiologic assessment. In vitro miconazole sensitivity was assessed for the H. pylori strains isolated from the enrolled patients. All patients were randomized to receive either dual therapy consisting of lansoprazole 30 mg daily and amoxicillin 500 mg three times a day for 14 days (LA, n = 33) or triple therapy using the LA regimen plus miconazole gel 100 mg three times a day for 14 days (LAM, n = 32). At least 8 weeks after the treatment, successful therapy was validated by the histological and microbiologic assessment. Adverse effects and drug adherence were monitored by direct questioning.
Results. The minimum inhibitory concentrations of miconazole ranged from 3.13 to 6.25 mg/L. H. pylori was eradicated in 16 of 33 patients (48%, 95% CI = 31% to 67%) after LA therapy, and 24 of 32 patients (75%, 95% CI = 59% to 91%) after LAM therapy ( p < .03). There was no significant difference in the occurrence of adverse events between the two groups.
Conclusion. The addition of miconazole gel to the LA regimen significantly improved the cure rate of H. pylori without an increase in adverse effects.     

Lafutidine versus Lansoprazole in Combination with Clarithromycin and Amoxicillin for One versus Two Weeks for Helicobacter pylori Eradication in Korea

Background and Aims: Lafutidine is a novel H₂‐receptor antagonist with gastroprotective activity that includes enhancement of gastric mucosal blood flow. The aim of the present study was to test the efficacy of 7‐ or 14‐day lafutidine–clarithromycin–amoxicillin therapy versus a lansoprazole‐based regimen for Helicobacter pylori eradication. Methods: Four hundred and sixty‐three patients with H. pylori‐infected peptic ulcer disease were randomized to one of four regimens: (1) lafutidine (20 mg b.i.d.), clarithromycin (500 mg b.i.d.) and amoxicillin (1000 mg b.i.d.) for 7 days (the 7LFT group) or (2) for 14 days (the 14LFT group); (3) lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxicillin (1000 mg b.i.d.) for 7 days (the 7LPZ group); or (4) for 14 days (the 14LPZ group). The eradication rates, drug compliance, and adverse effects among the four regimens were compared. Results: The eradication rates by the intention‐to‐treat and per‐protocol analyses in the 7LFT and 7LPZ groups were 76.5% and 81.6%, and 76.9% and 82.0% (p = .94 and .95), respectively. The eradication rates by intention‐to‐treat and per‐protocol analyses in the 14LFT and 14LPZ groups were 78.2% and 82.2%, and 80.4% and 85.9% (p = .70 and .49), respectively. The treatment duration for 7 days or 14 days did not affect the eradication rates. In addition, the adverse effect rates and discontinuation rates were similar among the four groups. Furthermore, the ulcer cure rate and symptom response rate were similar in the lafutidine and lansoprazole groups. Conclusion: The results of this study showed that lafutidine–clarithromycin–amoxicillin therapy was a safe and effective as lansoprazole‐based triple therapy for the eradication rate of H. pylori, and could be considered as an additional treatment option.