Sequential treatment for Helicobacter pylori eradication in duodenal ulcer patients: improving the cost of pharmacotherapy (original) (raw)
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Alimentary Pharmacology and Therapeutics, 2004
Background: Predicting factors for the outcome of conventional Helicobacter pylori triple therapy have been identified. Of these, the presence of the CagA 2 gene is a strong predictor of successful treatment. Our preliminary data show that this factor becomes irrelevant when sequential therapy is used. Aim: To identify predicting factors for the outcome of H. pylori eradication using two therapeutic schemes (triple and sequential) of equal duration (10 days). Methods: Ninety-six patients with H. pylori infection were randomly assigned to receive one of the following therapeutic schemes: group A: rabeprazole (20 mg b.d.) plus amoxicillin (1 g b.d.) for 5 days, followed by rabeprazole (20 mg b.d.) plus tinidazole (500 mg b.d.) and clarithromycin (500 mg b.d.) for a further 5 days; group B: rabeprazole (20 mg b.d.) plus amoxicillin (1 g b.d.) and clarithromycin (500 mg b.d.) for 10 days. Age, sex, smoking, endoscopic and histological findings, and CagA and VacA status were considered as candidates for a model of multivariate analysis which used therapeutic outcome as the dependent variable. CagA and VacA status were assessed by polymerase chain reaction on DNA isolated from gastric antral specimens. Results: The sequential scheme was significantly more effective than prolonged triple therapy (P < 0.05). Smoking (P < 0.001) and the absence of the CagA gene (P < 0.05) were significantly associated with the failure of triple therapy, but the effectiveness of sequential treatment was not predicted by these factors. Conclusion: Our data suggest that sequential therapy is not affected by bacterial and host factors which have, until now, predicted the outcome of conventional eradication treatments.
International Journal of Current Research in Medical Sciences, 2017
Background: Helicobacter pylori (H.pylori) colonization is the main main risk factor for peptic ulceration as well as for gastric adenocarcinoma and gastric MALT (mucosa-associated lymphoid tissue) lymphoma. Till date optimal therapeutic regimen has not been defined for H.pylori eradication, so present study is being conducted to compare efficacy of 10-day sequential triple therapy versus 14-days sequential therapy for the eradication of H. pylori. Methods. Four hundred H. pylori positive patients (diagnosed by rapid urease test and histology), were randomized to receive 10-day sequential therapy as follows with Omeprazole (20 mg) plus Amoxicillin (1 g) twice⁄day for five days, followed by Omeprazole (20 mg) with Tinidazole (500 mg) twice⁄day and Clarithromycin (500 mg) twice⁄day for five consecutive days and 14 Days Sequential Therapy with Omeprazole (20mg bid), Amoxicillin (1gm bid) for seven days, followed by Omeprazole (20mg) with Clarithromycin (500mg) and Tinidazole (500mg twice/day) for seven consecutive days respectively. Eradication rates were determined four weeks after treatment by rapid urease test. Results. Though the eradication rate was 80 % and 86 in 10 days sequential therapy group and 14 days sequential therapy group respectively, there was no statistically significant difference in eradication rates in these two groups ('p'value>0.05). Conclusions. 14 days Sequential therapy group had better eradication rates as compared to 10 days Sequential therapy group but results were not statistically significant when both the groups were compared together.
Alimentary Pharmacology and Therapeutics, 2003
Aim: To compare the efficacy of different regimens in patients in whom previous Helicobacter pylori eradication therapy has failed. Methods: In this study named StratHegy patients (n ¼ 287) were randomized to receive one of three empirical triple therapy regimens or a strategy based on antibiotic susceptibility. The empirical regimens were omeprazole, 20 mg b.d., plus amoxicillin, 1000 mg b.d., and clarithromycin, 500 mg b.d., for 7 days (OAC 7), clarithromycin, 500 mg b.d., for 14 days (OAC 14) or metronidazole, 500 mg b.d., for 14 days (OAM 14). In the susceptibility-based strategy, patients with clarithromycin-susceptible strains received OAC 14 , whilst the others received OAM 14. The 13 C-urea breath test was performed before randomization and 4-5 weeks after eradication therapy. Results: In the intention-to-treat analysis, the eradication rates for empirical therapies were as follows: OAC 7 , 47.4% (27/57); OAC 14 , 34.5% (20/58); OAM 14 , 63.2% (36/57); it was 74.3% (84/113) for the susceptibilitybased treatment (P < 0.01 when compared with OAC 7 and OAC 14). In patients receiving clarithromycin, the eradication rates were 80% for clarithromycin-susceptible strains and 16% for clarithromycin-resistant strains; in patients receiving OAM 14 , the eradication rates were 81% for metronidazole-susceptible strains and 59% for metronidazole-resistant strains. Conclusions: Eradication rates of approximately 75% can be achieved with second-line triple therapy based on antibiotic susceptibility testing. If susceptibility testing is not available, OAM 14 is an appropriate alternative.
High eradication rates of Helicobacter pylori with a new sequential treatment
Alimentary Pharmacology and Therapeutics, 2003
Background: Eradication rates of Helicobacter pylori with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. Aim: To assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection. Methods: One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy [rabeprazole (40 mg daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg) twice daily for the remaining 5 days] or standard 7-day treatment [rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g) twice daily]. H. pylori status was assessed by histology, rapid urease test and 13 C-urea breath test at baseline and 6 weeks or more after completion of treatment.
Annals of internal medicine
Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide. To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers. Randomized, double-blind, placebo-controlled trial. Two Italian hospitals between September 2003 and April 2006. 300 patients with dyspepsia or peptic ulcers. (13)C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, and assessment of antibiotic resistance. A 10-day sequential regimen (40 mg of pantoprazole, 1 g of amoxicillin, and placebo, each administered twice daily for the first 5 days, followed by 40 mg of pantoprazole, 500 mg of clarithromycin, and 500 mg of tinidazole, each administered twice daily for the remaining 5 days) or standard 10-day therapy (40 mg of pantoprazole, 500 mg of clarithromycin, and 1 g of amoxicillin, each administered twice daily). The eradication rate a...
Alimentary Pharmacology and Therapeutics, 2001
There is still no ideal therapy to cure Helicobacter pylori. Very recently, the European H. pylori Study Group recommended a`package treatment' including a ®rstline triple therapy with proton pump inhibitor, amoxicillin (AMO) and clarithromycin (CLA), and, in the event of an eradication failure, a second-line quadruple therapy with proton pump inhibitor, bismuth, metronidazole (MTZ) and tetracycline. 1 Although several controlled clinical trials have shown that standard triple therapies are effective in most patients, a signi®cant proportion of patients fails to eradicate the bacterium. The relevance of treatment failure is increasing worldwide as more and more people are treated for H. pylori infection. In a recent meta-analysis, triple therapy consisting of proton pump inhibitor plus two antibiotics achieved a pooled eradication rate of 90% with 95% con®dence intervals (CI) ranging from 81% to 100%. 2 This means that up to 20% of patients are expected to fail therapies in clinical trials; this value could be even higher in clinical practice. Bacterial resistances to MTZ or CLA and poor drug compliance are generally considered to be the most important causes of eradication failure. 4 However, other SUMMARY Background: Triple therapy with proton pump inhibitor, clarithromycin and amoxicillin has recently been proposed in Maastricht as ®rst-line treatment for H. pylori infection. Aim: To determine predictors of unsuccessful eradication. Methods: Two hundred and forty-eight patients underwent endoscopy with biopsies for rapid urease test, histology and culture with antibiotic susceptibility tests, and 13 C-UBT. All infected patients were given pantoprazole (40 mg b.d.), clarithromycin (500 mg b.d.) and amoxicillin (1 g b.d.) for 1 week. Eradication was assessed by UBT at 4±6 weeks after therapy. Results: One hundred and sixty-two of 248 patients (65%) were infected. Culture was positive in 144 (89%). Prevalence rates of metronidazole, clarithromycin and
Comparison of Ten-Day Sequential and Standard Triple Therapy for Helicobacter pylori Eradication
ACTA MEDICA IRANICA
Helicobacter pylori (HBP) is reported as one of the main causes of peptic ulcer disease (PUD) and gastric cancer in the world. The challenge for finding an optimal treatment regimen for HBP eradication is still a matter of concern. The aim of this study was to compare the HBP eradication rate as well as side effects between two 10-days treatments of the standard triple and sequential regimen. This study was performed on patients with dyspepsia and HBP positive. Patients were categorized in two treatment groups including; standard (Omeprazole, Amoxicillin, and Clarithromycin) and sequential treatment (Omeprazole, Amoxicillin, Clarithromycin, and Metronidazole). HBP eradication rate, side effects, and treatment costs were compared between two groups. One hundred thirty-two patients (58 males, 74 females) with a mean age of 42.7±14.2year-old were studied in two groups of Standard Treatment (n=66) and Sequential Treatment (n=66). There were not any significant differences between two groups regarding baseline features. The overall rate of HBP eradication was estimated to be 79.5%. Although, there was not any significant difference between the observed side effects, the mean cost of treatment in standard was significantly lower than that in the sequential group (P=0.001). It seems that there are not any clinical differences between 10-day treatment plan of the standard triple and sequential therapy in the case of HBP eradication and side effects. However, the sequential treatment might be a better option as the economic point of view.
Concomitant, sequential, and hybrid therapy for H. pylori eradication: A pilot study
Clinics and Research in Hepatology and Gastroenterology, 2013
Background and objective: Since the efficacy of the standard triple therapies for Helicobacter pylori eradication has decreased, novel antibiotic regimens have been introduced, including concomitant, sequential, and hybrid therapies. We aimed to compare the cure rates achieved by these new therapy regimens. Methods: This was a multicenter, open-label, pilot study enrolling consecutive non-ulcer dyspepsia patients with H. pylori infection never previously treated for the infection. Patients were randomized to receive one of the following treatments: (a) concomitant therapy: omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and tinidazole 500 mg for 5 days; (b) sequential therapy: omeprazole 20 mg and amoxicillin 1 g for 5 days followed by omeprazole 20 mg, clarithromycin 500 mg, and tinidazole 500 mg for 5 days; (c) hybrid therapy: omeprazole 20 mg, and amoxicillin 1 g for 7 days followed by omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and tinidazole 500 mg, for 7 days. All drugs were administered twice daily. Bacterial eradication was checked 6 weeks after treatment by using a 13 C-urea breath test. A 10-day, second-line therapy with omeprazole 20 mg, levofloxacin 250 mg, and amoxicillin 1 g, all given twice daily, was offered to the eradication failure patients. Results: Overall, 270 patients were enrolled, but 13 patients early interrupted treatment due to side effects. At intention-to-treat (ITT) and per-protocol analysis (PP), the eradication rates were 85.5% and 91.6% with the concomitant regimen, 91.1% and 92.1% with the sequential therapy, and 80% and 85.7% with the hybrid regimen. Differences were not statistically significant. H. pylori infection was cured in 10 (55.6%) patients with the second-line regimen. Conclusion: In our study, both concomitant and sequential therapy, but not hybrid therapy, reached high eradication rates. The success rate of second-line levofloxacin-based triple therapy is decreasing.
Journal of Medical Microbiology, 2014
Helicobacter pylori eradication remains a challenge for physicians. Sequential, concomitant and the hybrid regimens have been proposed as novel, more effective therapies. We compare the efficacy of these therapies. Dyspeptic patients referred for upper endoscopy with H. pylori infection were enrolled. Patients were randomized to receive: (a) sequential therapy -20 mg omeprazole and 1 g amoxicillin for 5 days, followed by 20 mg omeprazole, 500 mg clarithromycin and 500 mg tinidazole for the successive 5 days; (b) concomitant therapy -20 mg omeprazole, 1 g amoxicillin, 500 mg clarithromycin and 500 mg tinidazole for either 5 days (5 day concomitant) or 14 days (14 day concomitant); or (c) hybrid therapy -20 mg omeprazole and 1 g amoxicillin for 7 days, followed by 20 mg omeprazole, 1 g amoxicillin, 500 mg clarithromycin and 500 mg tinidazole for the successive 7 days. All drugs were given twice daily. Bacterial eradication was checked by using a [ 13 C]urea breath test. In 'intention-to-treat' analysis, sequential therapy achieved the highest eradication rate, which was higher than that of 5 day concomitant therapy (90 vs 78.1 %; P50.02). The success rate did not statistically differ among the sequential and either 14 day concomitant (90 vs 86.3 %; P5not significant) or hybrid therapies (90 vs 82.7 %; P5not significant). The 10 day sequential, 14 day concomitant and 14 day hybrid therapies, but not the 5 day concomitant regimen, achieved similarly high eradication rates. The lower therapeutic cost coupled with the lower number of tablets needed would favour the sequential therapy as the first-line H. pylori treatment in clinical practice.