Significant Difference In Eradication Rate Research Articles

Sitafloxacin-based third-line rescue regimens for Helicobacter pylori infection in Japan

Quinolone-based regimens have been used as the rescue for eradication of Helicobacter pylori. Sitafloxacin is known to have low minimum inhibitory concentration for H. pylori. Here, we compared two sitafloxacin-based eradication regimens as rescue for the eradication of H. pylori. We attempted to eradicate H. pylori in 180 Japanese patients who had never failed in eradication of H. pylori with the triple proton pump inhibitor/amoxicillin/clarithromycin therapy (1st line) and the triple proton pump inhibitor/amoxicillin/metronidazole therapy (2nd line). They were assigned to either the triple therapy with rabeprazole 10 mg b.i.d./q.i.d., amoxicillin 500 mg q.i.d, and sitafloxacin 100 mg b.i.d. (RAS) for 1 or 2 weeks or the triple therapy with rabeprazole 10 mg b.i.d./q.i.d., metronidazole 250 mg b.i.d., and sitafloxacin 100 mg b.i.d. (RMS) for 1 or 2 weeks. Eradication was assessed via the (13) C-urea breath test and rapid urease test. Intention-to-treat and per-protocol analyses of eradication rates were 84.1% (37/44) and 86.4% (37/43) with RAS for 1 week, 88.9% (40/45) and 90.9% (40/44) for RAS for 2 weeks, 90.9% (40/44) and 90.9% (40/44) for 1 week-RMS and 87.2% (41/47) and 91.1% (41/45) with RMS for 2 weeks. We noted no statistical significant differences in eradication rates among four regimens. All of the above-described rescue regimens proved relatively equally useful in the eradication of H. pylori. Of them, RAS for 2 weeks and RMS for 1 or 2 weeks could attain the rescue eradication rates higher than 90% by per-protocol analysis.

Comparison of sequential and 7-, 10-, 14-d triple therapy forHelicobacter pyloriinfection

To compare the effectiveness of sequential therapy for Helicobacter pylori (H. pylori) infection with that of triple therapy of varying durations. The 460 patients enrolled in this study had H. pylori-associated gastritis or a gastric or duodenal ulcer. After screening, H. pylori-infected patients were randomly assigned to receive either conventional triple therapy for 7, 10 or 14 d, or a new 10-d sequential therapy. Each of the 4 treatment groups included 115 patients. The outcomes of eradication therapy were assessed 4 wk after treatment by the urea breath test and histology. The overall eradication rate was 81.0%, and eradication rates were 75.7% for 7-d conventional triple therapy, 81.9% for 10-d conventional triple therapy, 84.4% for 14-d conventional triple therapy, and 82.0% for 10-d sequential therapy. Neither intention-to-treat analysis nor per protocol analysis showed significant differences in eradication rates using sequential therapy or the standard triple therapy (P = 0.416 and P = 0.405, respectively). There are no significant differences between 10-d sequential eradication therapy for H. pylori and any duration of standard triple treatment in Korean patients.

Comparison of Two Different Treatment Protocols in Helicobacter pylori Eradication

The prevalence of Helicobacter pylori (H pylori) in Turkey is high and eradication rates are low. As a result, alternative treatment strategies are required. To evaluate the status of H pylori eradication in Turkey by comparing the results of this study to other studies reported in the literature. Two hundred and eighty-two patients diagnosed with H pylori were included in this study. Patients were randomized into two groups. The first group consisted of 138 patients receiving 30 mg lansoprazole bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid for 14 days. The second group consisted of 144 patients who received lansoprazole 30 mg bid and amoxicillin 1 g bid for seven days, followed by metronidazole 500 mg bid, tetracycline 500 mg qid, and lansoprazole 30 mg bid for an additional seven days. H pylori eradication rates in the first group were 53.6% according to intention-to-treat analysis, and 52.5% according to per protocol analysis. In the second group, eradication rates were 72.2% per intention-to-treat analysis and 77.6% as per protocol analysis. H pylori eradication rates in the second group were significantly higher than the first group (P=0.001, P<0.05), whereas the incidence of adverse events in the second group was significantly lower (P=0.048, P<0.05). This study found a significant difference in eradication rates between the traditional triple therapy and modified sequential therapy groups. As a result, modified sequential therapy shows promise as an alternative treatment.

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 in chinese adults

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.

A New Four-day Regimen with Dexlansoprazole, Moxifloxacin, Amoxicillin, Nitazoxanide, and Doxycycline (DeMAND) in Helicobacter Pylori Therapy: An Open-label Randomized Clinical Trial

Purpose: Treatment failure for Helicobacter Pylori is due to antimicrobial resistance, and recrudescence. This study utilizes shorter regimen for better compliance and efficacy. Methods: 75 (N=75)-naïve dyspeptic patients underwent upper endoscopy with biopsies with positive DNA PCR H. pylori and stool H. pylori antigen. All were randomized into three arms: DeMAND Group (n=25): Oral Dexlansoprozole 60 mg, Moxifloxacin 400 mg, Amoxicillin 1 gram; Doxycycline 100 mg once, and Nitazoxanide 500 mg twice daily for four days; LOAD Group (n=25) oral: Levofloxacin 250 mg, Omeprazole 40 mg, and Doxycycline 100 mg once a day, with Alinia 500 mg twice daily for seven days; LAC Group (n=25) with traditional regimen of lansoprazole 15 mg, Amoxicillin I gram, Clarithromycin 500 mg twice daily for seven days. Exclusion: active bleeding, pregnancy, antimicrobial hypersensitivity, and use of antisecretory and antimicrobials within eight weeks. Results: 68 patients (90.7%) completed with seven (9%) total dropouts. Side events were minor rash, dizziness, diarrhea and palpitations. 30 days post-therapy stool antigen test of H. pylori was negative in 19/25 patients (76%-ITT analysis) in Group A, 22/25 (88%) in LOAD Group, and 18/25 (72%) in LAC Group, with no significant difference in eradication rate amongst all arms (χ2=2.1, p=0.36). Per-protocol analysis revealed no difference (χ2=2.4, p=0.30) in eradication rate amongst DeMAND (19/23=82.6%), LOAD (22/23=95%), LAC (18/22=81%). Conclusion: The 4-day DeMAND regimen is safe and as effective as the LOAD and LAC therapy for eradicating H. pylori, with shorter length and comparable cost benefits. Larger trial warrants validation.

Recent Six-Year Experiences of PPI-Based Triple Therapy of Heliobacter pylori

Purpose: The success rate of Proton pump inhibitor (PPI) based triple therapy for Heliobacter pylori eradication has been decreased recently. The aim of this study was to evaluate the recent 6-year experience of the eradication and the reinfection rates after the successful eradication of H. pylori infection in a single center of Korea. Methods: From March 2002 to April 2008, 584 patients with H. pylori-positive peptic ulcer disease and gastritis received the PPI-based triple therapy for 7 days (PPI, amoxicillin 1 g, clarithromycin 500 mg all twice daily). 13C-urea breath test was assessed to determine the H. pylori status after the eradication. The 83 patients with mean 1.2-years follow-up after the successful eradication were included. The eradication rate and the effect of age, gender, activity and the location of ulcer and the types of PPI were examined. Results: The overall H. pylori eradication rate was 83.7%. Annual success rate of H. pylori eradication from year 2003 to 2007 tended not to be decreased (95.7, 86.6, 80.7, 83.5, and 86%, respectively). The eradication rate was not different according to types of PPI (lansoprazole vs. omeprazole vs. rabeprazole; 82.6, 86.2, 84.7%, respectively). There were also no significant difference in eradication rate according to gender, age, the activity and location of the ulcer. The cumulative reinfection rate and the recurrence rate of peptic ulcer was 6.0% and 18.3% during mean 1.2 year follow up period. However, the recurrence of the disease was not associated with the status of H. pylori infection. Conclusion: PPI-based triple therapy seems to be still effective for the first-line therapy of H. pylori eradication. However a new treatment regime should be developed to overcome the lower eradication rate.

Efficacy of Helicobacter pylori eradication therapy in chronic liver disease

Peptic ulcers occur more commonly in patients with liver cirrhosis (LC). Helicobacter pylori is recognized as the most important etiology in the pathogenesis of peptic ulcers. We investigated the efficacy of proton pump inhibitor (PPI)-based triple therapy in patients with chronic liver disease and peptic ulcer. One hundred sixty-three patients with LC or chronic hepatitis (CH) with a peptic ulcer and proven H. pylori infection were included. The combination of PPI, amoxicillin (1.0 g), and clarithromycin (500 mg), each given twice daily, was administered for 1 or 2 weeks. The eradication of H. pylori was determined by the rapid urease test, histology, or the 13C-urea breath test at least 4 weeks after completing the treatment. The eradication rate of H. pylori was similar between the LC and CH groups; 82.6% and 88.1%, respectively. In addition, there were no significant differences in eradication rates between the patients with Child-Pugh class A and Child-Pugh class B/C disease. The side effects in each group were generally mild. Only the serum ALT levels showed a significant correlation with the success of H. pylori eradication in both the LC and CH groups. The PPI-based triple therapy achieves high eradication rates for H. pylori infection, in patients with chronic liver disease, without significant side effects.

Do patients with non-ulcer dyspepsia respond differently toHelicobacter pylorieradication treatments from those with peptic ulcer disease? A systematic review

It is controversial whether patients with non-ulcer dyspepsia (NUD) respond differently to Helicobacter pylori (H pylori) eradication treatment than those with peptic ulcer disease (PUD). To review the evidence for any difference in H pylori eradication rates between PUD and NUD patients. A literature search for full articles and meeting abstracts to July 2004 was conducted. We included studies evaluating the efficacy of a proton pump inhibitor (P) or ranitidine bismuth citrate (RBC) plus two antibiotics of clarithromycin (C), amoxicillin (A), metronidazole (M), or P-based quadruple therapies for eradicating the infection. Twenty-two studies met the criteria. No significant difference in eradication rates was found between PUD and NUD patients when treated with 7-d RBCCA, 10-d PCA or P-based quadruple therapies. When the 7-d PCA was used, the pooled H pylori eradication rate was 82.1% (431/525) and 72.6% (448/617) for PUD and NUD patients, respectively, yielding a RR of 1.15 (95%CI 1.01-1.29). However, the statistically significant difference was seen only in meeting abstracts, but not in full publications. There is no convincing evidence to suggest that NUD patients respond to H pylori eradication treatments differently from those with PUD, although a trend exists with the 7-d PCA therapy.

Efficacy of omeprazole and amoxicillin with either clarithromycin or metronidazole on eradication ofHelicobacter pyloriin Chinese peptic ulcer patients

One-week triple therapy with proton pump inhibitors, clarithromycin and amoxicillin has recently been proposed as the first-line treatment for Helicobacter pylori (H. pylori) infection; however, data regarding the effects of this regimen in China are scarce. The aim of this prospective and randomized study was to compare the efficacy of clarithromycin and metronidazole when they were combined with omeprazole and amoxicillin on eradication of H. pylori and ulcer healing in Chinese peptic ulcer patients. A total of 103 subjects with H. pylori-positive peptic ulcer were randomly divided into two groups, and accepted triple therapy with omeprazole 20 mg, amoxicillin 1000 mg and either clarithromycin 500 mg (OAC group, n = 58) or metronidazole 400 mg (OAM group, n = 45). All drugs were given twice daily for 7 d. Patients with active peptic ulcer were treated with omeprazole 20 mg daily for 2-4 wk after anti-H. pylori therapy. Six to eight weeks after omeprazole therapy, all patients underwent endoscopies and four biopsies (two from the antrum and two others from the corpus of stomach) were taken for rapid urease test and histological analysis (with modified Giemsa staining) to examine H. pylori. Successful eradication was defined as negative results from both examination methods. One hundred patients completed the entire course of therapy and returned for follow-up. The eradication rate of H. pylori for the per-protocol analysis was 89.3% (50/56) in OAC group and 84.1% (37/44) in OAM group. Based on the intention-to-treat analysis, the eradication rate of H. pylori was 86.2% (50/58) in OAC group and 82.2% (37/45) in OAM group. There were no significant differences in eradication rates between the two groups on either analysis. The active ulcer-healing rate was 96.7% (29/30) in OAC group and 100% (21/21) in OAM group (per-protocol analysis, P>0.05). Six patients in OAC group (10.3%) and five in OAM group (11.1%) reported adverse events (P>0.05). One-week triple therapy with omeprazole and amoxicillin in combination with either clarithromycin or metronidazole is effective for the eradication of H. pylori. The therapeutic regimen comprising metronidazole with low cost, good compliance and mild adverse events may offer a good choice for the treatment of peptic ulcers associated with H. pylori infection in China.

Effects of rebamipide, a gastro‐protective drug on the Helicobacter pylori status and inflammation in the gastric mucosa of patients with gastric ulcer: a randomized double‐blind placebo‐controlled multicentre trial

To investigate the effects of rebamipide on the Helicobacter pylori eradication rate with amoxicillin and omeprazole. The trial also examined its histological effects on gastro-mucosal inflammation after eradication. Two hundred and six H. pylori-positive patients with active gastric ulcer underwent 8-week based therapy (OA) consisting of 2-week amoxicillin with omeprazole and subsequent 6-week omeprazole. They randomly received either rebamipide (OA-R) or placebo (OA-P) for 16 weeks: combined with the OA based therapy, and subsequently for another 8 weeks. Besides eradication rate, inflammatory findings of gastric mucosa after eradication were evaluated histologically. Per Protocol Set analysis showed no significant difference in eradication rate between OA-R (64.6%; 95% confidence interval, 54.3-75.0%) and OA-P (67.9%; 95% CI, 57.6-78.3%). Histological findings in the gastric mucosa of the ulcer region, however, indicated a significant improvement (P = 0.017) in inflammation scores in OA-R (1.84 +/- 0.41) compared with that in OA-P (2.02 +/- 0.39) after 16-weeks of treatment. This suppressive effect on inflammation was observed even in the OA-R patients unsuccessfully eradicated. Rebamipide demonstrated a suppressive effect on the persistent and possibly chronic inflammation in the gastric mucosa of the ulcer region after eradication, but the drug did not improve the eradication rate.

Efficacy and Tolerability of Three Regimens for Helicobacter pylori Eradication

Helicobacter pylori plays a pivotal role in gastroduodenal disease. Ranitidine bismuth citrate (RBC)-based triple therapies for a period of 7 days have proven to be an effective treatment for H. pylori. The aim of this study was to compare the eradication efficacy and tolerability profile of a 7-day course of RBC plus clarithromycin and amoxicillin, RBC plus clarithromycin, and omeprazole plus clarithromycin and amoxicillin. Prospective, randomised, double-blind, multicentre study. A total of 154 H. pylori-positive patients with dyspeptic symptoms were randomised to RBC 400mg twice daily (bid) plus clarithromycin 500mg bid and amoxicillin 1g bid (RBCCA group, n = 53); RBC 400mg bid plus clarithromycin 500mg bid (RBCC group, n = 52); or omeprazole 20mg bid plus clarithromycin 500mg bid and amoxicillin 1g bid (OCA group, n = 49) administered for 7 days. H. pylori infection was initially detected on an antral biopsy by the rapid urease test and confirmed by 13C-urea breath test. H. pylori status was assessed by 13C-urea breath test at least 28 days after the end of treatment. There were no statistically significant differences in eradication rates per intention-to-treat (ITT) analysis (n = 149) and per protocol (PP) analysis (n = 135) among the three regimens. Eradication rates per ITT were 82.6% [95% confidence interval (CI), 69.2 to 92%] for RBCCA; 82% (95% CI, 68.7 to 91.9%) for RBCC; and 72.3% (95% CI, 57.7 to 85.6%) for OCA. The corresponding figures for the PP analysis were 85.1% (95% CI, 71.1 to 93.1%), 83% (95% CI, 68.7 to 91.9%), and 73.2% (95% CI, 56.8 to 85.2%), respectively. All regimens were well tolerated. Adverse events occurred in 59 (38%) of the 154 patients and included minor gastrointestinal symptoms and neurological complaints (anxiety, insomnia and headache). The results of this study suggest that the best approach to eradicate H. pylori may be the combination of ranitidine bismuth citrate with clarithromycin either with or without amoxicillin.

Efectividad de la combinación de omeprazol, claritromicina y amoxicilina en la erradicación de Helicobacter pylori en pacientes con ulcus péptico activo: resultados preliminares del Estudio GEHPY*

To compare the effectiveness of two length of the same therapy to eradicate Helicobacter pylori in patients with non complicated active peptic ulcer. 223 patients visited at primary health centres. A randomised controlled trial was carried out to compare the results of 6 or 7 days of treatment with clarithromycin 500 mg, amoxicillin 1 g and omeprazole 20 mg, b.i.d. All patients received omeprazole for other 14 days. 108 patients were randomised to the 6 days group and 115 to the 7 days one. Both groups were comparable with respect to basic characteristics except for sex: the proportion of men was higher in the 6 days group (p = 0.04). 91.4% of the patients received all the treatment correctly. By intention to treat analysis, eradication rates were 76.9% in the 6 days group and 77.4% in the seven days group (IC 95% of the difference from -10.5 to 11.6). There were not statistically significant differences in eradication rates in relation to age, sex, ulcer location, recurrence or tobacco consumption. Although eradication rates are lower than expected, in this study there are no differences between 6 or 7 days of therapy.

Efficacy of omeprazole plus two antimicrobials for the eradication of Helicobacter pylori in a Turkish population

Omeprazole combined with 2 antimicrobials has been suggested as a first-line option for Helicobacter pylori eradication in recent years. However, controversy exists regarding the efficacy of this protocol. This open-label, prospective clinical study investigated the efficacy of omeprazolebased triple therapy for H pylori eradication in 518 patients with H pylori-positive functional dyspepsia with or without duodenal ulcer. Amoxicillin, macrolides (clarithromycin or roxithromycin), and nitroimidazoles (metronidazole, ornidazole, or tintdazole) were the antibiotics used in the study. Nonulcer patients were randomly assigned to 1 of 8 different treatment protocols anu duodenal ulcer patients were randomly assigned to 1 of 4 different treatment protocols consisting of omeprazole (20 mg once daily for nonulcer patients, 20 mg twice daily for ulcer patients for 14 days) with a combination of 2 of the above antimicrobials (for 10 days). H pylori infection was assessed by histologic findings and a rapid urease test before therapy and 4 weeks after therapy ended. Four hundred fifty-nine patients completed their regimens; 327 had functional dyspepsia (180 men, 147 women; median age, 39 years; range, 18 to 70 years) and 132 had ulcers (81 men, 51 women; median age, 40 years; range, 18 to 70 years). Eradication of H pylori was achieved in 58.8% (270 of 459) of all patients, 58.1% (190 of 327) of nonulcer dyspeptic patients, and 60.6% (80 of 132) of duodenal ulcer patients. The eradication rate varied from 47.2% to 69.4% in different treatment protocols. There were no statistically significant differences in eradication rates in any treatment group. All drugs were generally well tolerated in all groups, and no patient discontinued treatment because of side effects. Therapy witn omeprazole and 2 antimicrobials for H pylori had limited efficacy in a Turkish population. The reason for these results, which conflict with those of other studies, is not clear. Further investigations of regimens for the eradication of H pylori in our population are necessary.

Azithromycin versus cefaclor in the treatment of acute exacerbations of chronic obstructive pulmonary disease

An open-label, randomized, multicenter study compared the efficacy and safety of once-daily azithromycin (500-mg dose on day 1 followed by 250 mg once daily on days 2 to 5) with those of cefaclor (500 mg three times daily for 10 days) in the treatment of lower respiratory tract infections. Two hundred one patients with acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) entered the study; 136 were treated with azithromycin and 65 with cefaclor. Sixty-four azithromycin-treated patients and 25 cefaclor-treated patients were evaluable for efficacy analysis. All patients (100%) in the azithromycin group achieved a successful clinical outcome (cure or improvement) compared with 23 of 25 (92.0%) patients in the cefaclor group. The difference between the two treatment groups was not statistically significant. Bacterial eradication of 75 of 86 (87.2%) isolates was achieved with azithromycin, compared with an eradication rate of 27 of 30 (90.0%) isolates with cefaclor. Haemophilus influenzae was eradicated by azithromycin in 19 of 21 (90.5%) patients and by cefaclor in six of nine (67.7%) patients. Streptococcus pneumoniae was successfully eradicated in all patients in both treatment groups (nine patients treated with azithromycin and four patients treated with cefaclor). There were no statistically significant differences in eradication rates between the two treatment groups. Both antibiotics were well tolerated; the incidence of side effects was similar for azithromycin and cefaclor, and only minor abnormalities in laboratory screening tests were noted in both treatment groups. In conclusion, once-daily azithromycin for 5 days is as effective and as well tolerated as three-times-daily cefaclor for 10 days in the treatment of patients with acute bacterial exacerbations of COPD.