Amoxycillin, clarithromycin and either sucralfate or pantoprazole for eradication of Helicobacter pylori in duodenal ulcer (a randomized controlled trial).

BACKGROUND: Sucralfate enhances the anti-Helicobacter pylori activity of antimicrobials and has an inhibitory effect on H. pylori. AIM: To evaluate the efficacy and safety of one-week sucralfate-based eradication therapy for H. pylori infection in patients with duodenal ulcers, compared with treatment based on pantoprazole, in a randomized controlled multicenter study. METHODS: One hundred and twenty patients with active duodenal ulcers and H. pylori infection were treated with amoxycillin 1 g b.d. plus clarithromycin 500 mg b.d. for the first 7 days. Patients were randomly assigned to receive either sucralfate 1 g t.d.s. for 4 weeks (SAC group; n = 60) or pantoprazole (PAC group; n = 60) 40 mg b.d. for the first 7 days and 40 mg o.d. for the next 3 weeks. The patient's H. pylori status was determined by a urease test and histological investigation before the treatment, and again 4 weeks after cessation of all medication. RESULTS: One hundred and eleven patients completed the study. H. pylori infection was eradicated in 76.4% (42/55) of patients in the SAC group (ITT analysis: 70%, 95% CI: 58-80%) vs. 85.7% (48/56) of patients in the PAC group (ITT analysis: 80%, 95% CI: 70-89) (N.S.). All ulcers had healed. There were no significant differences between the two regimens regarding the occurrence of adverse effects. CONCLUSION: Our study shows that one-week triple therapy with amoxycillin, clarithromycin and either pantoprazole or sucralfate are effective regimens to cure H. pylori infection in patients with duodenal ulcer.

Pantoprazole, amoxycillin and either azithromycin or clarithromycin for eradication of Helicobacter pylori in duodenal ulcer.

BACKGROUND: Studies have shown that 1-week triple therapy consisting of a proton pump inhibitor, amoxycillin and clarithromycin may cure Helicobacter pylori infection in the majority of patients. AIM: To establish whether pantoprazole plus amoxycillin in association with either azithromycin or clarithromycin is useful in curing H. pylori infection in patients with a duodenal ulcer. METHODS: One hundred and ten patients with active duodenal ulcers and H. pylori infection were treated with pantoprazole (days 1-7, 40 mg b.d.; days 8-28 40 mg o.d.) plus amoxycillin 1 g b.d. for the first 7 days. Patients were randomly assigned to receive either azithromycin 500 mg o.d. for the first 6 days (PAAz group; n=55) or clarithromycin 500 mg b.d. for the first 7 days of treatment (PAC group; n=55). H. pylori status was determined by urease test and histology before the treatment, and again 4 weeks after cessation of any medication. RESULTS: One hundred and three patients completed the study. H. pylori infection was eradicated in 78% (39/50) of patients in the PAAz group (ITT analysis: 71%, 95% CI: 61-83%) vs. 81% (43/53) of patients in the PAC group (ITT analysis: 78%, 95% CI: 69-90%) (N.S.). All ulcers had healed. CONCLUSION: Our study shows that 1-week triple therapy with pantoprazole, amoxycillin and either azithromycin or clarithromycin is not satisfactory (<80% ITT H. pylori eradication rate).

High dose omeprazole plus amoxicillin and azithromycin in eradication of Helicobacter pylori in duodenal ulcers.

BACKGROUND: The aim of our study was to establish whether one-week triple therapy regimen (omeprazole, amoxicillin, azithromycin) with low dose (2 x 20 mg/day) or high dose omeprazole (2 x 40 mg/day) is more effective in curing H. pylori infection in patients with active duodenal ulcer disease. METHODS: One hundred and twenty patients with duodenal ulcer and H. pylori infection were treated with amoxicillin 2 x 1000 mg/day for the first 7 days plus azithromycin 500 mg/day for the first 6 days. Patients were randomly assigned to receive either omeprazole 2 x 20 mg/day for the first 7 days (group A; n = 60) or omeprazole 2 x 40 mg/day for the first 7 days (group B; n = 60). After 7 days all patients in both groups continued treatment with omeprazole (40 mg/day (days 8-14) and 20 mg/day (days 15-28)). H. pylori status was determined by urease test and histology before the treatment and 4 weeks after cessation of any medication. RESULTS: One hundred and thirteen patients completed the study. H. pylori infection was eradicated in 73.2% [41/56] of patients in group A (intention-to-treat [ITT] analysis: 68.3%; 95% CI: 58.6-80.4%) vs. 82.5% [47/57] of patients in group B (ITT analysis: 78.3%; 95% CI: 67.8-87.9%; NS). All ulcers had healed after 4 weeks of omeprazole treatment. Side effects, usually minor, were recorded in 12.5% (group A) and in 14% (group B) of patients (NS), but therapy was discontinued for only one patient in group B (NS). CONCLUSION: There was no statistically significant difference between one-week triple therapy regimen (omeprazole, amoxicillin, azithromycin) with high dose omeprazole (2 x 40 mg/day) and regimen with low dose omeprazole (2 x 20 mg/day) in curing H. pylori infection in patients with active duodenal ulcer disease.

Pantoprazole versus omeprazole in the treatment of reflux esophagitis.

Pantoprazole is a new proton pump inhibitor with a potent antisecretory activity, well defined pharmacokinetics and safety profile. The aim of this single blind, randomized clinical trial was to compare the efficacy of pantoprazole (PAN) 40 mg/day and omeprazole (OME) 20 mg/day in patients with grade I and II GERD (Savary-Miller classification). A total of 120 patients were included (PAN = 60 and OME = 60). In the per protocol/analysis, healing rates at 4 weeks were 76.3% PAN and 71.2% OME (ns), and at 8 weeks 94.7% PAN and 92.9% OME (ns). In the intention to treat analysis, healing rates at 4 weeks were 75% PAN and 70% OME (ns), and at 8 weeks 90% PAN and 86.6% OME (ns). Both pantoprazole and omeprazole were well tolerated with no serious drug related adverse events. Pantoprazole 40 mg/day was found to be safe and effective therapy comparable to omeprazole 20 mg/day in the short-term treatment for reflux esophagitis (grade I and II).

Omeprazole, azithromycin and either amoxycillin or metronidazole in eradication of Helicobacter pylori in duodenal ulcer patients.

BACKGROUND: Azithromycin is a new generation, acid stable, macrolide antibiotic that achieves remarkably high concentrations in gastric tissue (above the minimal inhibitory concentration for Helicobacter pylori) after oral administration. AIM: To establish whether azithromycin plus omeprazole in association with either amoxycillin or metronidazole are useful in curing H. pylori infection in patients with a duodenal ulcer. METHODS: One hundred patients with active duodenal ulcers and H. pylori infection were treated with omeprazole (days 1-10, 40 mg b.d.; days 11-24, 40 mg o.m.; days 25-42, 20 mg o.m.) plus azithromycin 500 mg o.m. for the first 6 days. Patients were randomly assigned to receive either amoxycillin 1 g b.d. (OAzA group: n = 50) or metronidazole 400 mg t.d.s. (OAzM group: n = 50) during the first 10 days of treatment. H. pylori status was determined by urease test and histology before the treatment and 6 weeks after completion of therapy. RESULTS: Ninety-seven patients completed the study. H. pylori infection was eradicated in 85% (41/48) of patients in the OAzA group (intention-to-treat analysis 82%) vs. 74% (36/49) of patients in the OAzM group (intention-to-treat analysis: 72%) (N.S.). All ulcers had healed after 6 weeks of omeprazole treatment. Side-effects, usually minor, were recorded in 13% (OAzA group) and 47% (OAzM group) of patients (P < 0.001), but therapy was discontinued for only one patient in the OAzA group (N.S.). CONCLUSION: Ten days of treatment with omeprazole plus (for the first 6 days) azithromycin and either amoxycillin or metronidazole provides effective regimens to cure H. pylori infection in patients with duodenal ulcer disease.

Infection with Helicobacter pylori and long-term use of non-steroidal antiinflammatory drugs.

The use of nonsteroidal anti inflammatory drugs (NSAID) is associated with an increased risk of peptic ulcer and of ulcer complications. However, the relation between Helicobacter pylori infection and gastroduodenal damage associated with NSAID use is unclear. This study investigated the prevalence of Helicobacter pylori infection in patients with arthritis (n = 85) taking NSAID, trying to find out whether the patients taking NSAID and infected with H. pylori were more likely to have dyspepsia, mucosal damage or chronic active gastritis than those without H. pylori infection. H. pylori was identified by biopsy, rapid urease test and histologic test. Dispeptic symptoms were assessed according to a standardized questionnaire. Gastroduodenal mucosal damage was graded endoscopically (using a modified Lanza scale) and the diagnosis of chronic gastritis was based on the histologic criteria of the Sydney system. The frequency of H. pylori infection was found to increase with age. No statistically significant difference was observed in the presence of damage to gastroduodenal mucosa between the patients with and without H. pylori infection. H. pylori infection was found to be associated with an increased frequency and severity of dyspeptic symptoms in patients with arthritis taking long-term NSAID. Chronic active gastritis was only present in patients with H. pylori infection. H. pylori infection was shown to be associated with an increased frequency and severity of dyspeptic symptoms in patients with arthritis on long-term NSAID therapy, without causing an increased damage to gastroduodenal mucosa.

Omeprazole, azithromycin and amoxicillin or amoxicillin plus clavulanic acid in eradication of Helicobacter pylori in duodenal ulcer disease.

Treatment with omeprazole (OME), azithromycin (AZI) and amoxicillin (AMO) resulted in encouraging Helicobacter pylori cure rates in pilot and control studies. The aim of this study was to establish whether OME + AZI in combination with either AMO or ACA (amoxicillin plus clavulanic acid) are effective in curing H. pylori infection. A hundred patients with active duodenal ulcer and H. pylori infection were treated with OME (day 1-10: 2 x 40 mg/day, day 11-24: 40 mg/day, day 25-42: 20 mg/day) plus AZI 500 mg/day for the first 6 days. Patients were randomly assigned to either AMO 2 x 1000 mg/day (group A, n = 50) or ACA 2 x 1250 mg/day (group B, n = 50) during the first 10 days of treatment. H. pylori status was determined by urease test and histology before and 6 weeks after completion of therapy. Ninety-five patients completed the study. H. pylori infection was eradicated in 85.4% (41/48) patients from group A (intention-to-treat (ITT) analysis: 82%) versus 91.5% (43/47) patients from group B (ITT) analysis: 86%) (NS). All ulcer had healed after 42 days of omeprazole treatment. Side effects, usually minor, were recorded in 12.5% (group A) and 14.9% (group B) of patients (NS). Therapy had to be discontinued in two patients (one in group A and one group B) only. Ten-days treatment with OME and AZI (for the first 6 days) with AMO or ACA are simple and highly effective regimens to cure H. pylori infection in patients with duodenal ulcer disease.

[Omeprazole and azithromycin with and without metronidazole in the eradication of Helicobacter pylori in duodenal ulcer disease]. / Omeprazol i azitromicin s metronidazolom ili bez njega za eradikaciju Helicobactera pylori u duodenalnoj ulkusnoj bolesti.

This prospective, single blind, randomized study was designed to compare the efficacy and tolerance of two therapeutic schedules for eradication of H. pylori in patients with duodenal ulcer. Patients were randomized into two groups. Group 1 (n = 25) was treated with omeprazole 20 mg each morning for 28 days, azithromycin 500 mg/day for 5 days and metronidazole 3 x 500 mg/day for 5 days. Group 2 (n = 25) was treated with omeprazole 20 mg/day for 28 days and azithromycin 500 mg/day for 5 days. H. pylori status was determined by rapid urease test and histology before and 1, 6 and 12 months after the therapy. After 4 weeks of treatment ulcers healed in 96% (24/25) of patients in the first group and in 92% (23/25) of patients in the second group. One and 12 months after the treatment, eradication of Helicobacter pylori was achieved in 72% (18/25) of patients in the first group and in 64% (16/25) of patients in the second group. In 12 months after the treatment ulcer recurred in 43.7% (7/16) of patients in whom H. pylori was not eradicated and in 2.9% (1/34) of patients with eradicated H. pylori. The side effects were minor and/or transitory and did not require discontinuation of the treatment.