Helicobacter pylori infection: Is sequential therapy superior to standard triple therapy? A single-centre Italian study in treatment-naive and non-treatment-naive patients

BACKGROUND:

Clarithromycin resistance has decreased the eradication rates of Helicobacter pylori.

AIMS:

To determine whether a 10-day course of sequential therapy (ST) is more effective at eradicating H pylori infection than triple therapy (TT) in the first or second line, and to assess side effects and compliance with therapy.

METHODS:

One hundred sixty treatment-naive and 40 non-treatment-naive patients who were positive for H pylori infection by ¹³C-urea breath test or endoscopy were enrolled. Eighty of 160 patients underwent TT, while 80 of 160 underwent ST 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. H pylori eradication was evaluated by ¹³C-urea breath test no sooner than four weeks after the end of treatment.

RESULTS:

Eradication was achieved in 59 of 80 treatment-naive patients treated with TT (74%), in 74 of 80 patients treated with ST (93%), and in 38 of 40 non-treatment-naive patients (95%). Eradication rates in treatment-naive patients with ST were statistically significantly higher than TT (92.5% versus 73.7%; P=0.0015; OR 4.39 [95% CI 1.66 to 11.58]). Mild adverse effects were reported for both regimens.

CONCLUSIONS:

ST appears to be a well-tolerated, promising therapy; however, randomized controlled trials with larger and more diverse sample populations are needed before it can be recommended as a first-line treatment.     

A randomized controlled trial comparing sequential with triple therapy for Helicobacter pylori in an Aboriginal community in the Canadian North

BACKGROUND:

Helicobacter pylori infection occurs more frequently in Arctic Aboriginal settings than elsewhere in North America and Europe. Research aimed at reducing health risks from H pylori infection has been conducted in the Aboriginal community of Aklavik, Northwest Territories.

OBJECTIVE:

To compare the effectiveness of the Canadian standard therapy with an alternative therapy for eliminating H pylori infection in Aklavik.

METHODS:

Treatment-naive H pylori-positive individuals were randomly assigned to a 10-day regimen (oral twice-daily doses) with rabeprazole (20 mg): standard triple therapy (proton pump inhibitor, added clarithromycin [500 mg] and amoxicillin [1 g] [PPI-CA]); sequential therapy (ST) added amoxicillin (1 g) on days 1 to 5, and metronidazole (500 mg) and clarithromycin (500 mg) on days 6 to 10. Participants with clarithromycin-resistant H pylori were randomly assigned to ST or quadruple therapy. Treatment effectiveness was estimated as per cent (95% CI) with a negative urea breath test at least 10 weeks after treatment.

RESULTS:

Of 104 (53 PPI-CA, 51 ST) randomized participants, 89 (49 PPI-CA, 40 ST) had post-treatment results. Per-protocol treatment effectiveness was 59% (95% CI 45% to 73%) for PPI-CA and 73% (95% CI 58% to 87%) for ST. Based on intention to treat, effectiveness was 55% (95% CI 41% to 69%) for PPI-CA and 57% (95% CI 43% to 71%) for ST. Of 77 participants (43 PPI-CA, 34 ST) with 100% adherence, effectiveness was 63% (95% CI 43% to 82%) for PPI-CA and 81% (95% CI 63% to 99%) for ST.

CONCLUSIONS:

While additional evidence is needed to confirm that ST is more effective for Arctic Aboriginal communities than the Canadian standard H pylori treatment, these results show standard PPI-CA treatment to be inadequate for communities such as Aklavik.     

Efficacy of 7-Day and 14-Day Bismuth-Containing Quadruple Therapy and 7-Day and 14-Day Moxifloxacin-Based Triple Therapy as Second-Line Eradication for Helicobacter pylori Infection

Background/Aims

Bismuth-containing quadruple and moxifloxacin-based triple regimens are recommended as second-line therapy for Helicobacter pylori infection. The aim of this study was to compare the efficacy of each regimen.

Methods

From August 2004 to October 2012, a total of 949 patients (mean age, 54.32±12.08 years; male, 49.4%) who failed H. pylori eradication with a standard triple regimen were included. Patients treated with a bismuth-containing quadruple regimen for 7 and 14 days were designated as 7-BMT and 14-BMT, respectively, and those treated with a moxifloxacin-based triple regimen for 7 and 14 days were designated as 7-MA and 14-MA, respectively. H. pylori eradication was confirmed using the ¹³C-urea breath test, rapid urease test or histology.

Results

The eradication rates by 7-BMT, 14-BMT, 7-MA, and 14-MA were 66.4% (290/437), 71.1% (113/159), 53.1% (51/96), and 73.5% (189/257), respectively, by intention-to-treat analysis (ITT) and 76.5% (284/371), 83.8% (109/130), 55.6% (50/90), and 80.6% (187/232), respectively, by per-protocol analysis (PP). The eradication rates were higher in 14-BMT than 7-BMT by the ITT and PP analyses (p=0.277 and p=0.082, respectively). The 14-BMT and 14-MA treatments showed similar efficacies by ITT and PP (p=0.583 and p=0.443, respectively).

Conclusions

The 7-BMT, 14-BMT, and 14-MA treatments showed similar and suboptimal efficacies. In both regimens, extending the duration of treatment may be reasonable considering the high level of antibiotic resistance in Korea.     

Furazolidone-based Therapies for Helicobacter pylori Infection: A Pooled-data Analysis

Background/Aim:

Furazolidone-based therapies are used in developing countries to cure Helicobacter pylori infection due to its low cost. The low bacterial resistance toward furazolidone may render appealing the use of this drug even in developed countries. However, some relevant safety concerns do exist in using furazolidone.

Patients and Methods:

This was a systematic review with pooled-data analysis of data regarding both eradication rate and safety of furazolidone-based therapies for H. pylori infection. Intention-to-treat (ITT) and per-protocol (PP) eradication rates were calculated.

Results:

Following furazolidone-based first-line therapy, H. pylori eradication rates were 75.7% and 79.6% at ITT and PP analysis, respectively (P<0.001). The overall incidence of side effects and severe side effects were 33.2% and 3.8%, respectively. At multivariate analysis, only high-dose furazolidone was associated with increased therapeutic success (OR: 1.5, 95% CI: 1.3-2.7; P<0.001), while occurrence of side effects was relevant following treatment for a long duration (OR: 2.9, 95% CI: 2.2-4.1; P<0.001), high-dose furazolidone (OR: 2.3, 95% CI: 1.7-3.2; P<0.001) and bismuth-containing regimens (OR: 2.1, 95% CI: 1.5-2.8; P<0.001).

Conclusions:

Furazolidone-based regimens usually achieve low eradication rates. Only a high-dose regimen improves the cure rate, but simultaneously increases the incidence of severe side effects. Therefore, we suggest that patients have to be clearly informed about the possible genotoxic and carcinogenetic effects for which furazolidone use is not approved in developed countries.     

Effect of Helicobacter pylori Eradication on the Development of Reflux Esophagitis and Gastroesophageal Reflux Symptoms: A Nationwide Multi-Center Prospective Study

Background/Aims

A two-year, prospective, nationwide multicenter study was undertaken to evaluate the effect of Helicobacter pylori eradication on the development of reflux esophagitis (RE) and gastroesophageal reflux disease (GERD) symptoms in the Korean population.

Methods

In total, 1,489 subjects without RE were enrolled at the outpatient clinics of 12 tertiary hospitals nationwide, and 452 subjects underwent follow-up (F/U) for 2 years to evaluate the development of RE and GERD symptoms.

Results

RE was found in 33 subjects (7.3% of 452 subjects) and 14 subjects (7.3% of 192 subjects) during the first and second year of F/U, respectively. H. pylori status was not associated with the development of RE. RE was found in six (9.0%) of 67 H. pylori-negative patients, in 26 (11.2%) of 233 eradicated subjects and in eight (7.0%) of 114 noneradicated subjects (p=0.532). Multivariate analysis showed that age ≥60 years (odds ratio [OR], 7.11; 95% confidence interval [CI], 1.92 to 26.41), alcohol consumption (OR, 4.43; 95% CI, 1.03 to 19.19) and F/U cholesterol levels ≥200 mg/dL (OR, 5.03; 95% CI, 1.32 to 19.17) were significant risk factors for the development of RE. There was no significant difference in the development of GERD symptoms or weight according to H. pylori status during the 2-year F/U.

Conclusions

Eradication of H. pylori did not affect the development of reflux esophagitis or GERD symptoms among patients in outpatient gastroenterology clinics in South Korea.     

Helicobacter pylori Seropositivity Is Associated with Gastric Cancer Regardless of Tumor Subtype in Korea

Background/Aims

To evaluate the association between Helicobacter pylori (H. pylori) infection and gastric cancer (GC) according to tumor subtype in Korea.

Methods

H. pylori status was determined serologically using the enzyme-linked immunosorbent assay. In total, 2,819 patients with GC and 562 healthy controls were studied. A logistic regression method was used after adjusting for possible confounders.

Results

The prevalence of H. pylori infection was significantly higher in the GC patients (84.7%) than in the controls (66.7%) (odds ratio [OR], 3.13; 95% confidence interval [CI], 2.46-3.97). The adjusted OR was significantly higher in H. pylori-infected patients aged <60 years (OR, 4.69; 95% CI, 3.44-6.38) than in those aged ≥60 years (OR, 1.48; 95% CI, 0.88-2.46; p<0.001). Subgroup analyses revealed no differences in seroprevalence between early gastric cancer (84.8%; OR, 3.01; 95% CI, 2.27-4.01) and advanced gastric cancer (84.6%; OR, 2.94; 95% CI, 2.24-3.85), cardia cancer (83.8%; OR, 2.98; 95% CI, 2.16-4.02) and noncardia cancer (84.8%; OR, 3.17; 95% CI, 2.48-4.04), and differentiated carcinoma (82.7%; OR, 2.99; 95% CI, 2.21-4.04) and undifferentiated carcinoma (86.8%; OR, 3.05; 95% CI, 2.32-4.00).

Conclusions

The seroprevalence of H. pylori was higher in GC patients than in healthy controls, especially in younger patients. H. pylori infection is associated with GC, regardless of the tumor location, stage, or differentiation.     

Comparison of the Eradication Rate between 1- and 2-Week Bismuth-Containing Quadruple Rescue Therapies for Helicobacter pylori Eradication

Background/Aims

First-line therapies against Helicobacter pylori, including proton pump inhibitors (PPIs) plus two antibiotics, may fail in up to 20% of patients. ''Rescue'' therapy is usually needed for patients who failed the first-line treatment. This study evaluated the eradication rate of bismuth-containing quadruple rescue therapy over a 1- or 2-week period.

Methods

We prospectively investigated 169 patients with a persistent H. pylori infection after the first-line triple therapy, which was administered from October 2008 to March 2010. The patients were randomized to receive a 1- or 2-week quadruple rescue therapy (pantoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d., metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.). After the ''rescue'' therapy, the eradication rate, compliance, and adverse events were evaluated.

Results

The 1-week group achieved 83.5% (71/85) and 87.7% (71/81) eradication rates in the intention to treat (ITT) and per-protocol (PP) analyses, respectively. The 2-week group obtained 87.7% (72/84) and 88.9% (72/81) eradication rate in the ITT and PP analyses, respectively. There was no significant difference in the eradication rate, patient compliance or rate of adverse events between the two groups.

Conclusions

One-week bismuth-containing quadruple therapy can be as effective as a 2-week therapy after the failure of the first-line eradication therapy.     

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

Background/Aims

Several 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.

Methods

In 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.

Results

According 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.

Conclusions

LML 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.     

Efficacy of the Combination of Tetracycline, Amoxicillin, and Lansoprazole in the Eradication of Helicobacter pylori in Treatment-Naïve Patients and in Patients Who Are Not Responsive to Clarithromycin-Based Regimens: A Pilot Study

Background/Aims

The aim of this study was to evaluate the eradication rate of a triple therapy regimen that included a proton pump inhibitor, amoxicillin, and tetracycline instead of clarithromycin in treatment-Naïve patients and in patients who did not respond to standard triple therapy.

Methods

This study included 110 patients infected with Helicobacter pylori. Patients in groups A and B were treatment-Naïve, and those in group C were not responsive to previous standard triple therapy. Patients in group A (n=40) received lansoprazole 30 mg b.i.d., amoxicillin 1,000 mg b.i.d., and clarithromycin 500 mg b.i.d. for 14 days. Patients in groups B (n=40) and C (n=30) received lansoprazole 30 mg b.i.d., amoxicillin 1,000 mg b.i.d., and tetracycline 500 mg q.i.d. for 14 days.

Results

In group A, eradication was achieved in 18 (45%) of the 40 patients included in the intention-to-treat (ITT) analysis and in 18 (47.4%) of the 38 patients included in the per-protocol (PP) analysis. In group B, eradication was achieved in 15 (37.5%) of the 40 patients included in the ITT analysis and in 15 (39.3%) of the 38 patients included in the PP analysis. In group C, eradication was achieved in 14 (46.6%) of the 30 patients included in the ITT analysis and in 14 (43.8%) of the 29 patients included in the PP analysis. There was no statistically significant difference among the 3 groups with regard to eradication rates (p>0.05).

Conclusions

Despite the low rate of resistance to tetracycline, the combination of lansoprazole, amoxicillin, and tetracycline instead of clarithromycin is not a good option for the eradication of H. pylori.     

Does Helicobacter pylori Exacerbate Gastric Mucosal Injury in Users of Nonsteroidal Anti-Inflammatory Drugs? A Multicenter,Retrospective, Case-Control Study

Background/Aims

The interaction between nonsteroidal anti-inflammatory drugs (NSAIDs) and Helicobacter pylori remains controversial. We retrospectively investigated whether H. pylori infection exacerbates severe gastric mucosal injury among chronic NSAID users.

Methods

From January 2010 to December 2013, a total of 245 long-term NSAID (including low-dose aspirin) users who had undergone an esophagogastroduodenoscopy and had been evaluated for H. pylori infection were enrolled at Okayama University Hospital and Tsuyama Chuo Hospital. The degree of gastric mucosal injury was assessed according to the modified Lanza score (MLS). Severe gastric mucosal injury was defined as an MLS ≥4. Univariate and multivariate logistic regression analyses were performed.

Results

In the univariate analysis, age ≥75 years (odds ratio [OR], 2.4; 95% confidence interval [CI], 1.3 to 4.2), H. pylori-positivity (OR, 2.0; 95% CI, 1.2 to 3.5), and the concomitant use of proton pump inhibitors (PPIs) (OR, 0.48; 95% CI, 0.26 to 0.86) were significantly associated with severe gastric mucosal injury. The multivariate analysis was adjusted by age and sex and demonstrated that H. pylori-positivity (OR, 1.8; 95% CI, 1.0 to 3.3) and the concomitant use of PPIs (OR, 0.53; 95% CI, 0.28 to 0.99) significantly contributed to severe gastric mucosal injury.

Conclusions

H. pylori infection exacerbates severe gastric mucosal injury among chronic NSAID users.     

High Recurrence Rate of Idiopathic Peptic Ulcers in Long-Term Follow-up

Background/Aims

Our aim was to compare the long-term clinical outcomes of idiopathic peptic ulcer disease (IPUD) with those of Helicobacter pylori-positive and nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcer disease (PUD).

Methods

Patients with endoscopically diagnosed PUD were retrospectively reviewed. According to their H. pylori-infection status and history of NSAIDs use, patients were categorized into three groups: H. pylori-positive PUD, NSAID-induced PUD, and IPUD. Clinical outcomes were analyzed, and the recurrence rate of PUD was compared among the three groups.

Results

A total of 238 patients were enrolled. Those with IPUD, NSAID-induced PUD, and H. pylori-positive PUD comprised of 56, 60, and 122 patients, respectively. The 5-year cumulative incidences of recurrent ulcers were 24.3% (95% confidence interval [CI], 11.6% to 37.0%) in IPUD, 10.9% (95% CI, 2.6% to 19.2%) in NSAID-induced PUD, and 3.8% (95% CI, 0.1% to 7.5%) in H. pylori-positive PUD (IPUD vs NSAID-induced PUD/H. pylori-positive PUD, p=0.43/p<0.001 by log-rank test). In the Cox-proportional hazards model, only IPUD remained as an independent risk factor associated with recurrent ulcers (hazard ratio, 5.97; 95% CI, 1.94 to 18.34; p=0.002).

Conclusions

IPUD exhibited a higher recurrence rate than H. pylori-positive and NSAID-induced PUD in long-term follow-up and was an independent risk factor for ulcer recurrence.     

Treatment for Eradication of Helicobacter pylori Infection among Chronic Hepatitis C Patients

Background/Aims

Helicobacter pylori infection causes gastritis, peptic ulcers and gastric malignancies, and its eradication has been advocated by many groups. We determined the H. pylori carrier status and eradication rates of patients with chronic hepatitis C virus (HCV) infection.

Methods

In total, 76 chronically HCV-infected patients were enrolled for comparison with 228 HCV-noninfected, age- and sex-matched controls. H. pylori infection was confirmed by H. pylori antibody and urea breath testing.

Results

The H. pylori infection rate was significantly higher for HCV-infected patients (67 of 76, 88.2%) than for HCV-noninfected controls (158 of 228, 69.3%). Endoscopic findings showed that the rates of gastric ulcers and gastritis were significantly higher for the 67 HCV-infected patients with H. pylori infection (34.3% and 77.6%) than for the 158 HCV-noninfected controls with H. pylori infection (15.2% and 57.6%). Treatment to eradicate H. pylori had a significantly higher success rate for HCV-infected patients (61 of 67, 91.0%) than for HCV-noninfected controls (115 of 158, 72.8%).

Conclusions

The markedly high H. pylori eradication rate observed in this study shows that eradication of H. pylori holds promise for the improvement of the long-term health condition of patients with chronic HCV infection.     

A 14-day course of triple therapy is superior to a 10-day course for the eradication of Helicobacter pylori: A Canadian study conducted in a ‘real world’ setting

BACKGROUND:

Successful Helicobacter pylori eradication with the traditional seven-day course of proton pump inhibitor (PPI) triple therapy is declining. Prolonging therapy to either 10 or 14 days is associated with better eradications rates.

OBJECTIVE:

To compare the effectiveness of 14-day course of triple therapy versus a 10-day course in the treatment of H pylori in Canada.

METHODS:

Consecutive treatment-naive patients with clinical indications for H pylori eradication underwent either a 10-day course or a 14-day course of traditional PPI triple therapy depending on the date of the office visit (an odd date received the 10-day course, whereas an even date received the 14-day treatment). H pylori eradication was ascertained via urea breath test or gastric biopsies performed ≥4 weeks after completion of therapy. Analyses were by both intention to treat and per-protocol.

RESULTS:

A total of 83 patients were included in the study (31 in the 10-day group and 52 in the 14-day group). In the intention-to-treat analysis, eradication rates were 82.7% (95% CI 70% to 92%) versus 45.2% (95% CI 27% to 64%), favouring the 14-day treatment (P<0.001). Similarly, in the per-protocol analysis, eradication rates were 91.5% (95% CI 80% to 98%) versus 63.6% (95% CI 41% to 83%), favouring the 14-day arm (P=0.01). Adverse events and compliance were not significantly different between the two groups.

CONCLUSION:

A 14-day course of standard PPI triple therapy was superior to a shorter-duration therapy and should be included as a first-line regimen for H pylori eradication in Canada. The 10-day course of treatment did not achieve an acceptable eradication rate and should no longer be used in this country.     

Do we eradicate Helicobacter pylori in hospitalized patients with peptic ulcer disease?

BACKGROUND:

Helicobacter pylori infection is the most common chronic infection in humans. It is a major contributor to the cause of duodenal and gastric ulcers worldwide. Its eradication has been shown to reduce rates of H pylori-related ulcers as well as other complications such as gastric cancer.

OBJECTIVE:

To determine the rate of appropriate treatment in patients following a diagnosis of H pylori infection on biopsy during esophagoduodenoscopy for upper gastrointestinal bleeding over a four-year period at a tertiary centre in Vancouver, British Columbia. Also evaluated was the rate of eradication confirmation using the urea breath test.

METHODS:

A retrospective review of 1501 inpatients who underwent esophagoduodenoscopy for upper gastrointestinal bleeding (January 2006 to December 2010) was undertaken. Patients who were biopsy stain positive for H pylori were selected for drug review either via a provincial database (PharmaNet) or via records from patients’ family practitioners. Data were also obtained via two provincial laboratories that perform the urea breath test to determine the rates of confirmation of eradication.

RESULTS:

Ninety-eight patients had biopsy-proven H pylori. The mean (± SD) age was 56.13±17.9 years and 65 were male. Data were not available for 22 patients; the treatment rate was 52.6% (40 of 76). Of those treated, 12 patients underwent a post-treatment urea breath test for eradication confirmation.

CONCLUSION:

There was substantial discrepancy between the number of diagnosed H pylori infections and the rate of treatment as well as confirmation of eradication. Numerous approaches could be taken to improve treatment and eradication confirmation.     

Treatment Outcome for Gastric Mucosa-Associated Lymphoid Tissue Lymphoma according to Helicobacter pylori Infection Status: A Single-Center Experience

Background/Aims

Helicobacter pylori eradication therapy has been used as a first-line treatment for H. pylori-positive gastric mucosa-associated lymphoid tissue (MALT) lymphoma. However, the management strategy for H. pylori-negative MALT lymphoma remains controversial. Therefore, the aim of this study was to examine the success rate of each treatment option for H. pylori-positive and H. pylori-negative gastric MALT lymphomas.

Methods

In total, 57 patients with gastric MALT lymphoma diagnosed between December 2000 and June 2012 were enrolled in the study. The treatment responses were compared between H. pylori-positive and H. pylori-negative gastric MALT lymphomas.

Results

Of the 57 patients, 43 (75%) had H. pylori infection. Forty-eight patients received H. pylori eradication as a first-line treatment, and complete remission was achieved in 31 of the 39 patients (80%) with H. pylori-positive MALT lymphoma and in five (56%) of the nine patients with H. pylori-negative MALT lymphoma; no significant difference was observed between the groups (p=0.135). The other treatment modalities, including radiation therapy, chemotherapy, and surgery, were effective irrespective of H. pylori infection status, with no significant difference in the treatment response between H. pylori-positive and H. pylori-negative MALT lymphomas.

Conclusions

H. pylori eradication therapy may be considered as a first-line treatment regardless of H. pylori infection status.     

Rifaximin Plus Levofloxacin-Based Rescue Regimen for the Eradication of Helicobacter pylori

Background/Aims

This study assessed the efficacy of a rifaximin plus levofloxacin-based rescue regimen in patients that had failed both triple and quadruple standard regimens for the eradication of Helicobacter pylori.

Methods

We treated patients for H. pylori between August 2009 and April 2011. The triple regimen consisted of combined treatment with amoxicillin, clarithromycin, and pantoprazole for 1 week. For failed cases, a quadruple regimen of tetracycline, metronidazole, bismuth dicitrate, and lansoprazole for 1 week was administered. The rescue regimen for persistently refractory cases was rifaximin 200 mg t.i.d., levofloxacin 500 mg q.d., and lansoprazole 15 mg b.i.d. for 1 week.

Results

In total, 482 patients were enrolled in this study. The eradication rates associated with the first and second regimens were 58% and 60%, respectively. Forty-seven out of 58 patients who failed with the second-line regimen received rifaximin plus levofloxacin-based third-line therapy. The eradication rate for the third regimen was 65%. The cumulative eradication rates were 58%, 85%, and 96% for each regimen, respectively.

Conclusions

A rifaximin plus levofloxacin-based regimen could be an alternative rescue therapy in patients with resistance to both triple and quadruple regimens for the eradication of H. pylori.     

The Influence of CYP2C19 Polymorphism on Eradication of Helicobacter pylori: A Prospective Randomized Study of Lansoprazole and Rabeprazole

Background/Aims

The CYP2C19 polymorphism plays an important role in the metabolism of various proton-pump inhibitors. Several trials have produced conflicting data on eradication rates of Helicobacter pylori (H. pylori) among CYP2C19 genotypes. We investigated whether the CYP2C19 genotype affects the eradication rate of H. pylori by direct comparing the effects of lansoprazole- and rabeprazole-based triple therapies.

Methods

A total of 492 patients infected with H. pylori was randomly treated with either 30 mg of lansoprazole or 20 mg of rabeprazole plus 500 mg of clarithromycin and 1,000 mg of amoxicillin twice daily for 1 week. CYP2C19 genotype status was determined by a PCR-restriction-fragment-length polymorphism method. After 7 to 8 weeks, H. pylori status was evaluated by a C¹³-urea breath test.

Results

Four hundred and sixty-three patients were analyzed, and the eradication rate was 75.2% in a per-protocol analysis. Eradication rates for the lansoprazole regimen (n=234) were 73.8%, 80.7%, and 85.4% in the homozygous extensive (HomEM), heterozygous extensive (HetEM), and poor metabolizers (PM) groups, respectively (p=0.303). In the case of the rabeprazole regimen (n=229), the eradication rates were 68.6%, 73.0%, and 71.9% in the HomEM, HetEM, and PM groups, respectively (p=0.795).

Conclusions

The efficacies of triple therapies that include lansoprazole or rabeprazole are not affected by CYP2C19 genetic polymorphisms.     

A Planned Prospective, Randomized, Placebo-Controlled Multicenter Trial Assessing the Effect of Helicobacter pylori Eradication on the Healing of Iatrogenic Ulcer after Endoscopic Resection of Gastric Neoplasm

Background/Aims

Helicobacter pylori eradication may facilitate the healing of iatrogenic ulcer after endoscopic resection of gastric neoplasm. This study involved designing a randomized, double-blinded, placebo-controlled, multicenter trial, performed by the Korean College of Helicobacter and Upper Gastrointestinal Research and the Medical Research Collaboration Center, Seoul National University Hospital.

Methods

We intend to enroll up to 232 patients H.-pylori-positive patients who have gastric adenoma or early gastric cancer after endoscopic resection. The enrolled patients are being randomly allocated to the H.-pylori-eradication-plus-proton-pump-inhibitor group or the placebo-plus-proton-pump-inhibitor group based on their histology results and the size of the resected specimen. After random allocation, the iatrogenic ulcer size and stage are evaluated at 4- and 8-week follow-ups (with a window of ±7 days). The primary end point is the healing rate of the ulcer by stage, and the secondary end point is the rate of ulcer size reduction, relief rate from ulcer-related symptoms, and adverse-event rates.

Results

More than 90% of the target subjects have already been enrolled into the study and are receiving ongoing periodic monitoring by the Medical Research Collaboration Center.

Conclusions

Completion of the study should reveal whether H. pylori eradication can facilitate the healing of ulcer after endoscopic resection in Korea.     

Cost Effectiveness Associated with Helicobacter pylori Screening and Eradication in Patients Taking Nonsteroidal Anti-Inflammatory Drugs and/or Aspirin

Background/Aims

This study was performed to investigate the cost effectiveness of Helicobacter pylori screening/eradication in South Korean patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and/or aspirin.

Methods

A decision Markov model was used to estimate the effectiveness and economic impact of an H. pylori screening/eradication strategy compared to a no-screening strategy among patients who were included in the model at the age of 40 years. Utility weights were applied to four of the health status groups to reflect quality-adjusted life years (QALY). The costs of screening, H. pylori eradication, and managing peptic ulcer and ulcer complications were obtained from South Korea-specific data.

Results

The total costs per patient were US $2,454 for the H. pylori screening/eradication and US $3,182 for the no-screening strategy. The QALYs for the two strategies were 16.05 and 15.73, respectively. The results were robust for the analyses of all different cohort groups who entered the model at the age of 30, 50, or 60 years and for NSAIDs-naïve patients. Through the probabilistic sensitivity analysis, the robustness of our study''s results was also determined.

Conclusions

The H. pylori screening/eradication strategy was found to be less expensive and more effective compared to the no-screening strategy among South Korean patients taking NSAIDs and/or aspirin.