s-1743 and Duodenal-Ulcer

Esomeprazole (Nexium); S-omeprazole) is a single optical isomer proton-pump inhibitor (PPI) approved for the management of reflux oesophagitis, the symptomatic treatment of gastro-oesophageal reflux disease (GORD), the prevention and healing of NSAID-associated gastric ulcer disease (and the prevention of NSAID-associated duodenal ulcers in the UK), the treatment of Helicobacter pylori infection and associated duodenal ulcer disease (and prevention of relapse of H. pylori-associated peptic ulcers in the UK), and the treatment of Zollinger-Ellison syndrome (and other hypersecretory syndromes in the US).Once-daily oral esomeprazole 40 mg demonstrates greater antisecretory activity than other PPIs. Overall, in well designed clinical studies of 4 weeks' to 6 months' duration in patients with GORD, esomeprazole had similar or better efficacy than other agents. In patients requiring ongoing treatment with NSAIDs, co-therapy with once-daily esomeprazole 20 or 40 mg achieved relief of gastrointestinal symptoms or prevented ulcer occurrence, more effectively than placebo. Esomeprazole was also better than ranitidine 150 mg twice daily in healing NSAID-associated gastric ulcers. In addition, the drug has demonstrated efficacy as part of a triple-therapy regimen for the eradication of H. pylori infection, the healing of H. pylori associated duodenal ulcers and the prevention of relapse of gastric ulcers. Esomeprazole also effectively treated patients with Zollinger-Ellison syndrome. Esomeprazole is generally well tolerated with an adverse-event profile similar to that of other PPIs. Thus, the efficacy and tolerability of esomeprazole for the management of GORD and H. pylori eradication remains undisputed, and the data support its use for the first-line treatment of NSAID-associated gastric ulcer disease and Zollinger-Ellison syndrome.

Topics: Adult; Anti-Ulcer Agents; Duodenal Ulcer; Esomeprazole; Gastroesophageal Reflux; Helicobacter Infections; Helicobacter pylori; Humans; Omeprazole; Proton Pump Inhibitors; Stomach Ulcer; Zollinger-Ellison Syndrome

Proton pump inhibitor-based triple therapy is the most commonly used treatment for eradication of Helicobacter pylori, with pooled eradication rates of approximately 90%. In the USA, per protocol eradication rates with 10-day proton pump inhibitor-based triple therapy are approximately 85%. Esomeprazole, a new proton pump inhibitor that is the S-isomer of omeprazole and produces a greater inhibition of acid secretion than omeprazole, has recently been evaluated in the treatment of H. pylori. Seven-day twice daily triple therapy with esomeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg provided intention-to-treat eradication rates of 86-90% and per protocol eradication rates of 90-91% in duodenal ulcer patients in Europe and Canada. Ten-day triple therapy with esomeprazole 40 mg q.d.s., amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. achieved intention-to-treat eradication rates of 77-78% and per protocol eradication rates of 84-85% in USA duodenal ulcer patients. Thus, esomeprazole triple therapy with amoxicillin and clarithromycin is effective in the treatment of H. pylori, with eradication rates comparable to previously studied proton pump inhibitor-based triple therapies.

Topics: Anti-Bacterial Agents; Anti-Ulcer Agents; Drug Therapy, Combination; Duodenal Ulcer; Enzyme Inhibitors; Esomeprazole; Helicobacter Infections; Helicobacter pylori; Humans; Omeprazole; Proton Pump Inhibitors

Esomeprazole, a new proton pump inhibitor, is the S-isomer of omeprazole and is the first such inhibitor to be developed as a single isomer. Esomeprazole provided better control of intragastric pH than omeprazole, lansoprazole and pantoprazole in trials conducted in patients with gastro-oesophageal reflux disease (GORD) or healthy volunteers (n = 20 to 115). In 2 large randomised, double-blind multicentre trials esomeprazole 20 and/or 40mg for 8 weeks produced higher healing rates of erosive oesophagitis and better symptom control than omeprazole 20 mg in patients with GORD. Esomeprazole 10, 20 or 40mg once daily for 6 months maintained healing versus placebo (p < 0.001) in patients with endoscopically confirmed healed erosive oesophagitis in 2 large randomised, double-blind multicentre trials. Similarly, symptom-driven on-demand use of esomeprazole effectively controlled symptoms of GORD (heartburn) for 6 months in 2 large placebo-controlled trials. Esomeprazole-based triple therapy for 7 days was as effective for eradication of Helicobacter pylori as longer omeprazole-based therapy in 2 randomised double-blind trials including about 450 patients each. Endoscopically confirmed ulcer healing 4 weeks after treatment initiation was reported in about 90% of patients with active duodenal ulcer in both treatment groups. Esomeprazole-based triple therapy for 10 days was more effective than esomeprazole plus clarithromycin for eradication of H. pylori in 233 patients.

Topics: Animals; Anti-Ulcer Agents; Clinical Trials as Topic; Duodenal Ulcer; Enzyme Inhibitors; Esomeprazole; Gastroesophageal Reflux; Helicobacter pylori; Humans; Omeprazole; Stereoisomerism

The objectives were to investigate the pharmacokinetics, pharmacodynamics and safety of ilaprazole infusion in healthy subjects and patients with esomeprazole as positive control, and then recommend the dosage regimen for Phase 2b/3 studies.. Three clinical studies were performed. First, 16 healthy subjects received infusion of ilaprazole 30 mg or esomeprazole 80 mg. Second, 12 healthy subjects received ilaprazole 20 mg followed by 10 mg once daily for 2 days. Finally, 20 patients with duodenal ulcers received ilaprazole 20 mg followed by 10 mg for 2 days or esomeprazole 40 mg twice daily for 3 days. Serial blood samples were collected and intragastric pH was recorded.. The mean percentages time of intragastric pH >6 was 63.6 and 51.7% for healthy subjects after receiving ilaprazole 30 mg and esomeprazole 80 mg. Linear pharmacokinetics was observed when the dose was increased to 30 mg but the effect was saturated. Ilaprazole 20 mg followed by 10 mg for 2 days provided higher plasma exposure in healthy subjects than patients, but the effect was comparable. After multiple administrations, ilaprazole provided similar effect to esomeprazole. Ilaprazole infusion was safe and well tolerated without serious adverse events.. Ilaprazole provided comparable effect of pH control to esomeprazole, with lower dose and fewer times of administration. There was no significant difference of ilaprazole between healthy subjects and patients regarding intragastric acid inhibition. A loading dose of ilaprazole 20 mg followed by 10 mg once daily for 2 days was recommended for Phase 2b/3 studies.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; China; Duodenal Ulcer; Duodenoscopy; Esomeprazole; Female; Gastric Acid; Gastric Acidity Determination; Healthy Volunteers; Humans; Infusions, Intravenous; Male; Middle Aged; Proton Pump Inhibitors; Treatment Outcome; Young Adult

To compare triple therapy with sequential and concomitant therapies directly in a head-to-head comparison in Helicobacter pylori-infected patients.. Patients were allocated randomly as follows: a triple therapy with esomeprazole (20 mg), amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 7 days; a sequential therapy with 5 days of esomeprazole (20 mg) and amoxicillin (1000 mg) twice daily, followed by 5 days of esomeprazole (20 mg), clarithromycin (500 mg) and metronidazole (400 mg) twice daily; or a concomitant therapy consisting of esomeprazole (20 mg), amoxicillin (1000 mg), clarithromycin (500 mg) and metronidazole (400 mg) twice daily for 7 days.. A total of 356 consecutive patients were included. The eradication rates for the triple, sequential and concomitant therapies were 83.6% [95% confidence interval (CI) 76.9-90.4%], 94.2% (95% CI 90.0-98.4%) and 91.7% (95% CI 86.7-96.6%), respectively, in the intention-to-treat population. The differences were significant only between triple and sequential therapies (P=0.01). The primary resistance rates to amoxicillin, clarithromycin and metronidazole were 0.6, 10.5 and 25.9%, respectively. Concomitant therapy was significantly better than triple therapy in cases with clarithromycin resistance (P=0.01).. Ten-day sequential therapy was significantly better than 7-day triple therapy in a clinical setting with low rates of clarithromycin and dual resistance. Concomitant therapy was significantly better than standard triple therapy in the subgroup of patients with clarithromycin-resistant strains.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Peptic Ulcer; Proton Pump Inhibitors; Stomach Ulcer; Treatment Outcome; Young Adult

Patients with high Rockall scores have increased risk of ulcer rebleeding after 3-day esomeprazole infusions.. To investigate whether double oral esomeprazole given after a 3-day esomeprazole infusion decreases ulcer rebleeding for patients with high Rockall scores.. We prospectively enrolled 293 patients with peptic ulcer bleeding who had achieved endoscopic haemostasis. After a 3-day esomeprazole infusion, patients with Rockall scores ≥6 were randomised into the oral double-dose group (n=93) or the oral standard-dose group (n=94) to receive 11 days of oral esomeprazole 40 mg twice daily or once daily, respectively. The patients with Rockall scores <6 served as controls (n=89); they received 11 days of oral esomeprazole 40 mg once daily. Thereafter, all patients received oral esomeprazole 40 mg once daily for two more weeks until the end of the 28-day study period. The primary end point was peptic ulcer rebleeding.. Among patients with Rockall scores ≥6, the oral double-dose group had a higher cumulative rebleeding-free proportion than the oral standard-dose group (p=0.02, log-rank test). The proportion of patients free from recurrent bleeding during the 4th-28th day in the oral double-dose group remained lower than that of the group with Rockall scores <6 (p=0.03, log-rank test). Among patients with Rockall scores ≥6, the rebleeding rate was lower in the oral double-dose group than in the oral standard-dose group (4th-28th day: 10.8% vs 28.7%, p=0.002).. Double oral esomeprazole at 40 mg twice daily after esomeprazole infusion reduced recurrent peptic ulcer bleeding in high-risk patients with Rockall scores ≥6.. NCT01591083.

Topics: Administration, Oral; Adult; Aged; Dose-Response Relationship, Drug; Drug Administration Schedule; Duodenal Ulcer; Esomeprazole; Female; Hemostasis, Endoscopic; Humans; Infusions, Intravenous; Male; Middle Aged; Peptic Ulcer Hemorrhage; Proton Pump Inhibitors; Secondary Prevention; Severity of Illness Index; Stomach Ulcer; Treatment Outcome

Patients with comorbidities have an increased risk of ulcer rebleeding, especially within the 28 days after endoscopic therapy. Omeprazole infusion can prevent rebleeding after endoscopic therapy in patients with peptic ulcer bleeding. However, the optimal duration is uncertain, especially for those patients with comorbidities.. To determine whether prolonged low-dose intravenous omeprazole could reduce rebleeding for patients with comorbidities.. A prospective randomized control study.. National Cheng Kung University, Tainan, Taiwan.. A total of 147 patients with comorbidities and peptic ulcer bleeding controlled by endoscopic hemostasis were enrolled.. The enrolled patients were randomized into either the 7-day low-dose group or the 3-day high-dose group, who received 3.3 mg/h or 8 mg/h continuous omeprazole infusion, respectively. After omeprazole infusion, oral esomeprazole 40 mg every day was given.. To compare the rebleeding rates within 28 days after gastroscopy between the 2 study groups.. The 7-day cumulative rebleeding rate was similar between the 2 groups (9.5% vs 9.7%, P > .05), but the 7-day low-dose group had a lower risk of rebleeding between the 8th and 28th day compared with the 3-day high-dose group (0% vs 10.7%, P = .03; relative risk, 0.52 [95% CI, 0.43-0.63]). The Kaplan-Meier curves confirmed that the 7-day low-dose group had a significantly higher cumulative rebleeding-free proportion between the 8th and 28th day than the 3-day high-dose group (P = .02, log-rank test).. In Asian patients, prolonged low-dose omeprazole infusion for 7 days may reduce peptic ulcer rebleeding during the first 28 days in patients with comorbidities.

Topics: Aged; Aged, 80 and over; Comorbidity; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Duodenal Ulcer; Education, Medical, Continuing; Esomeprazole; Female; Follow-Up Studies; Hemostasis, Endoscopic; Humans; Infusions, Intravenous; Kaplan-Meier Estimate; Male; Middle Aged; Omeprazole; Peptic Ulcer Hemorrhage; Probability; Prospective Studies; Risk Assessment; Secondary Prevention; Severity of Illness Index; Statistics, Nonparametric; Stomach Ulcer; Survival Rate; Time Factors; Treatment Outcome

There were authentic distinctions between the groups of healthy volunteers and patients with a peptic ulcer disease in Cmax, Tmax, AUC(0-t), AUC(0-infinity), CIt, Vd of omeprazole and Cmax of esomeprazole (Nexium, AstraZeneca). When the pharmacokinetics of omeprazole and ezomeprazole were compared in both groups, there were authentic distinctions in Cmax, AU(0-t), AUC(0-infinity), CIt, T1/2. The patients who had taken omeprazole the time of hypoacide condition was much shorter than in other groups. Disintegration test modeling pHmax for pH oscillation with large amplitude, that is typical for ulcer disease, demonstrated a possibility of early partial release of omeprazole, its acid-depended degradation and reduction of its bioavailability.

Topics: Adult; Anti-Ulcer Agents; Biological Availability; Duodenal Ulcer; Esomeprazole; Female; Gastric Acid; Gastric Acidity Determination; Humans; Male; Omeprazole; Proton Pump Inhibitors; Time Factors; Tissue Distribution

To evaluate the efficacy and tolerability of two different preparations of esomeprazole in healing duodenal ulcers.. A total of 60 patients with active duodenal ulcers were enrolled and randomized to receive esomeprazole enteric-coated capsules (40 mg) or esomeprazole magnesium (40 mg), once daily, for 4 consecutive wk, with ulcer healing being monitored by endoscopy. Safety and tolerability were also assessed.. Fifty seven patients completed the whole trial. The ulcer healing rates at the end of wk 2 were 86.7% and 85.2% in the esomeprazole enteric-coated capsules and esomeprazole magnesium groups, respectively (P = 0.8410), and reached 100% at the end of wk 4 in both groups. Symptom relief at the end of wk 2 was 90.8% in the esomeprazole enteric-coated capsules group and 86.7% in the esomeprazole magnesium group (P = 0.5406); at the end of wk 4 symptom relief was 95.2% and 93.2%, respectively (P = 0.5786). Adverse events occurred in 16.7% of the esomeprazole enteric-coated capsules group and 14.8% of the esomeprazole magnesium group (P = 1.0000).. The efficacies of esomeprazole enteric-coated capsules and esomeprazole magnesium in healing duodenal ulcer lesions and relieving gastrointestinal symptoms are equivalent. The tolerability and safety of both drugs were comparable.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Dosage Forms; Double-Blind Method; Duodenal Ulcer; Esomeprazole; Female; Humans; Male; Middle Aged; Treatment Outcome

In this randomized, double-blind, multicenter study, H. pylori-positive patients with an active duodenal ulcer (DU) received esomeprazole, 20 mg twice daily (bid), or omeprazole, 20 mg bid, with amoxicillin, 1000 mg bid, and clarithromycin, 500 mg bid, for 1 week (EAC and OAC, respectively). Patients received an additional 3 weeks of either placebo or omeprazole, 20 mg once daily (od), in the EAC and OAC groups, respectively. The intent-to-treat population included 374 patients (EAC, 186; OAC, 188). Four-week DU healing rates were similar in the EAC+placebo and OAC+omeprazole groups: 74% and 76%, respectively. DU healing rates at 8 weeks were 87% for EAC+placebo and 88% for OAC+omeprazole. H. pylori eradication rates were 75% and 79% for EAC and OAC, respectively. Both regimens were well tolerated. A 1-week regimen of esomeprazole-based H. pylori eradication triple therapy was as effective for DU healing and eradication of H. pylori as omeprazole-based triple therapy followed by an additional 3 weeks of monotherapy.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Double-Blind Method; Duodenal Ulcer; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole

Proton pump inhibitors reduce ulcer recurrence in non-steroidal anti-inflammatory drug (NSAID) users, but their impact in at-risk ulcer-free patients using the current spectrum of prescribed agents has not been clearly defined. We assessed esomeprazole for ulcer prevention in at-risk patients (> or = 60 yr and/or ulcer history) taking NSAIDs, including COX-2 inhibitors. Such studies are particularly relevant, given that concerns regarding adverse cardiovascular outcomes among COX-2 inhibitor users may prompt re-evaluation of their use.. We conducted two similar double-blind, placebo-controlled, randomized, multicenter studies; VENUS (United States) and PLUTO (multinational). A total of 844 and 585 patients requiring daily NSAIDs, including COX-2 inhibitors were randomized to receive esomeprazole (20 or 40 mg) or placebo, daily for 6 months.. In the VENUS study, the life table estimated proportion of patients who developed ulcers over 6 months (primary variable, intent-to-treat population) was 20.4% on placebo, 5.3% on esomeprazole 20 mg (p < 0.001), and 4.7% on esomeprazole 40 mg (p < 0.0001). In the PLUTO study, the values were 12.3% on placebo, 5.2% with esomeprazole 20 mg (p = 0.018), and 4.4% with esomeprazole 40 mg (p = 0.007). Significant reductions were observed for users of both non-selective NSAIDs and COX-2 inhibitors. Pooled ulcer rates for patients using COX-2 inhibitors (n = 400) were 16.5% on placebo, 0.9% on esomeprazole 20 mg (p < 0.001) and 4.1% on esomeprazole 40 mg (p= 0.002). Esomeprazole was well tolerated and associated with better symptom control than placebo.. For at-risk patients, esomeprazole was effective in preventing ulcers in long-term users of NSAIDs, including COX-2 inhibitors.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis, Rheumatoid; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Duodenal Ulcer; Esomeprazole; Female; Humans; Male; Middle Aged; Osteoarthritis; Proton Pump Inhibitors; Risk Factors; Stomach Ulcer

H. pylori eradication is a challenge in patients allergic to penicillin, both first-line and failures of prior therapy. We aimed to assess the eradication rate of H. pylori in patients allergic to penicillin, first-line and failures of prior therapy, the efficacy of healing of active duodenal ulcer disease (DUD) and erosive gastritis, and the safety and tolerability of the combination. Twenty patients with documented allergy to penicillin, DUD, and H. pylori infection, 17 (85%) for first-line treatment and 3 (15%) prior therapy failures, were given a 10-day regimen of esomeprazole, 40 mg qid, tetracycline, 500 mg qid, and metronidazole, 500 mg qid. Baseline and follow-up panendoscopy > or =30 days after end of treatment was performed for rapid urease test (Clotest), and four site biopsies for H. pylori, and to document endoscopic peptic ulcer disease. All adverse events during treatment were documented. Eradication rates by intention to treat (ITT) were 85% for first-line treatment and 100% for failures. Seventy percent of all cases had a normal endoscopy at follow-up, and 85 and 100% of patients had healed erosive gastritis and DUD, respectively, from baseline. There were histological improvements in most patients. A high eradication rate was obtained even in patients who had a shorter duration of treatment. The combination was well tolerated. A combination of esomeprazole, tetracycline, and metronidazole is effective for eradication of H. pylori in patients allergic to penicillin, for both first-line treatment and failures of prior treatment.

Topics: Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Drug Hypersensitivity; Drug Therapy, Combination; Duodenal Ulcer; Esomeprazole; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Penicillins; Tetracycline; Treatment Outcome

To investigate the effect of esomeprazole- and omeprazole-based triple therapy regimens in the treatment of duodenal ulcer with Helicobacter pylori (Hp) infection.. Totally 104 patients with duodenal ulcer and Hp infection were randomly divided into group A (52 cases) treated with esomeprazole (20 mg), amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily and group B (52 cases) treated with omeprazole (20 mg), amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily. The treatment lasted for 7 days, after which abdominal pain relief rate, ulcer healing rate and eradication rate of Hp as well as adverse effects of the medication were evaluated and compared.. On the first and second days of medication, the abdominal pain relief rates were 34.6% and 59.6% respectively in group A, significantly higher than those in group B (17.3% and 38.5%, respectively, P<0.05). Ulcer healing rate and Hp eradication rate were 92.3% and 88.5 % in group A, and 88.5% and 82.7% in group B, showing no significant differences between the two groups (P>0.05). The adverse effects of the medication were rare in both groups without significant differences.. Esomeprazole-based triple therapy may effectively eradicate Hp infection and promote duodenal ulcer healing with good tolerance, capable of achieving more speedy pain relief than omeprazole-based therapy.

Topics: Adolescent; Adult; Aged; Amoxicillin; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole

To study the efficacy of esomeprazole-based triple therapy in Helicobacter pylori eradication and to evaluate, by a randomized trial, the effect of increasing the dose of esomeprazole or prolonging the treatment.. Four-hundred and fifty duodenal ulcer patients were randomized to receive: (1) esomeprazole (20 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxicillin (1 g b.i.d.), for 7 days (E20-7d); (2) esomeprazole (40 mg b.i.d.) with the same antibiotics, also for 7 days (E40-7d); and (3) esomeprazole (40 mg b.i.d.) with the same antibiotics, for 10 days (E40-10d). Cure rates were evaluated by (13)C-urea breath test.. One-hundred and fifty patients received each treatment. Groups were comparable in terms of demographic variables. Eight percent of the patients did not return for follow-up. Compliance (98%) and side effects (only mild to moderate) in the two groups were comparable. Per-protocol cure rates were 83.5% (E20-7d), 84.8% (E40-7d), and 88.2% (E40-10d). Intention-to-treat cure rates were, respectively, 74%, 78%, and 80% (nonstatistically significant differences).. Esomeprazole-based triple therapies offer comparable efficacy to omeprazole-based therapies used in previous studies. Increasing the dose of esomeprazole or prolonging the treatment does not improve the results. Therefore, if esomeprazole-based triple therapy is used in duodenal ulcer patients, a regimen with only 20 mg twice daily of esomeprazole and for only 7 days may be sufficient.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Duodenal Ulcer; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole

To assess efficiency of esomeprazole in the treatment of duodenal ulcer (DU) associated with H. pylori in various eradication regimens.. 80 patients with duodenal ulcer at least 0.5 cm in diameter were randomized into three groups. 23 patients of group 1, 28 patients of group 2 received esomeprazole for 7 days in a dose 20 mg twice a day, in a single morning dose 40 mg, respectively. 29 patients of group 3 received omeprazole 20 mg twice a day for 7 days and further 3 weeks 20 mg twice a day. All the patients were also given amoxicillin 1000 mg twice a day and clarithromycin 500 mg twice a day for a week.. An antisecretory effect of esomeprazole as shown by 24-h monitoring of gastric secretion was longer and more stable than that of omeprazole: a latent period averaged 1.5 +/- 0.6 h in a pharmacological test with 20 mg esomeprazole, 1.2 +/- 0.4 h in intake of 40 mg esomeprazole and 2.1 +/- 0.3 h in intake of 20 mg omeprazole. Overall duration of the antisecretory effect averaged 16.8 +/- 1.9, 20.3 +/- 1.7 and 12.5 +/- 1.9 h, respectively. The time of intragastric pH > 4 was 13.1 +/- 1.6, 17.2 +/- 1.6 and 9.8 +/- 1.5 hours, respectively. Eradication of H. pylori in group 1, 2 and 3 was 91.3, 89.3 and 89.6%, respectively. Complete epithelization of ulcer occurred in 95.6, 92.8 and 93.1% cases, respectively. In 77 patients who finished the treatment according to the protocol the treatment resulted in eradication in 95.6, 92.5 and 92.8%, respectively; in epithelization--in 100, 96.3 and 96.4% patients of groups 1, 2 and 3, respectively. Side effects were mild or moderate but not causing changes of the regimen or treatment discontinuation.. Esomeprazole in three-component treatment was highly effective in eradication of H. pylori and epithelisation of duodenal ulcer defects in various regimens of administration. Esomeprazole in combination with amoxicillin and clarithromycin reduces the time of treatment of DU associated with H. pylori to 1 week without further monotherapy with antisecretory drugs.

Topics: Adult; Anti-Infective Agents; Anti-Ulcer Agents; Duodenal Ulcer; Enzyme Inhibitors; Esomeprazole; Female; Helicobacter Infections; Humans; Male; Omeprazole

There is a disclosure of the results of one-week eradication therapy (esomeprazole, 20 mg + Flemoxin Solutab, 1,000 mg + Clarithromycin, 500 mg, twice a day) without any subsequent antisecretory therapy. In order to control the healing of non-complicated ulcers of the duodenal bulb, the first control endoscopy (esophagogastroduodenoscopy) was conducted after 7 days, and the second one was conducted 4 weeks after the termination of patients' treatment. The healing of ulcers of the duodenal bulb was recorded in 89.5% and 89.5% of cases, respectively. A control determination of the H. pylori semination of the mucous coating of stomach was accomplished 4 weeks after the termination of patients' treatment. According to the data of the fast urease test and 13C-urease respiratory test, the HP eradication was recorded in all of the patients (100%), and according to the data of the histologic method of target biopsy materials studies, it was recorded in 94.7% of cases. A pharmacoeconomic analysis of the acquired data showed that the seven-day eradication therapy of non-complicated duodenal ulcer, where esomeprazole was used as the basic preparation, is most efficient and most economically expedient.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Cost-Benefit Analysis; Drug Administration Schedule; Duodenal Ulcer; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Penicillins

The results of one-week eradication therapy of uncomplicated duodenal ulcer disease associated with Helicobacter pylori by Ezomeprasol, Clarithromycin and Amoxicillin (accordingly 20 mg, 500 mg and 1000 mg twice per day) are presented. The results of the adhesion of uncomplicated ulcers of duodenal bulb in 4 weeks after termination of eradication treatment course--the adhesion of the ulcers was observed in 17 of 19 patients (89.5%). The eradication of Helicobacter pylori according the data of fast urease test and 13C-urease respiratory test was determined in all 19 patients (100%), on the data of histological method--in 18 of 19 patients (94.7%).

Topics: Amoxicillin; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Duodenal Ulcer; Esomeprazole; Helicobacter pylori; Humans; Prospective Studies

Proton pump inhibitor (PPI) monotherapy is commonly continued for 3 weeks after Helicobacter pylori eradication with PPI-based triple therapy regimens to ensure duodenal ulcer (DU) healing. This randomized, double-blind, multicentre study evaluated whether only 1 week of triple therapy with the new PPI esomeprazole was sufficient to ensure high rates of ulcer healing and H. pylori eradication.. A total of 446 H. pylori-positive patients with active DU received twice daily treatment with esomeprazole 20 mg (n = 222) or omeprazole 20 mg (n = 224) in combination with amoxicillin 1 g and clarithromycin 500 mg for 1 week (EAC and OAC, respectively). Patients in the OAC group then received 3 weeks' monotherapy with omeprazole 20 mg once daily; those treated with EAC received placebo. Ulcer healing was assessed by endoscopy on completion of therapy and H. pylori status was assessed by (13)C-urea breath testing and histology 4-6 weeks later.. Ulcer healing rates (95% CI) for intention-to-treat and per-protocol populations were: EAC + placebo 91% (87-95%) and 94% (90-97%); OAC + omeprazole 92% (88-95%) and 96% (92-98%). Corresponding H. pylori eradication rates were: EAC + placebo 86% (81-90%) and 89% (84-93%); OAC + omeprazole 88% (83-92%) and 90% (85-93%). Both eradication regimens were well tolerated, and patient compliance was high.. A 1-week regimen of esomeprazole-based triple therapy is sufficient for DU healing and H. pylori eradication in patients with DU disease.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Endoscopy, Gastrointestinal; Enzyme Inhibitors; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Penicillins; Time Factors; Treatment Outcome

Esomeprazole is the first proton pump inhibitor to be developed as an optical isomer for the treatment of acid-related diseases.. Four hundred and forty eight duodenal ulcer patients with Helicobacter pylori infection, confirmed by 13C-urea breath test (UBT), and no current ulcer, were randomised to double-blind treatment with esomeprazole 20 mg twice daily (b.d.) (n=224) or omeprazole 20 mg b.d. (n=224), in combination with amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. for 1 week (EAC and OAC, respectively). A negative UBT at both 4 and 8 weeks after completing therapy indicated successful H. pylori eradication.. Intention-to-treat (ITT) analysis comprised 400 patients (EAC, n=204; OAC, n=196) and per protocol (PP) analysis 377 patients (EAC, n=192; OAC, n=185). Eradication rates (95% confidence intervals) for ITT and PP populations were: EAC, 90% (85-94%) and 91% (86-94%); OAC, 88% (82-92%) and 91% (86-95%). Between-group differences in eradication rates were not statistically significant. Both regimens were well tolerated, with an adverse event profile and frequency typical of proton pump inhibitor plus antibiotic combination therapy.. Esomeprazole-based triple therapy for 1 week is highly effective in eradicating H. pylori infection in duodenal ulcer disease, offers comparable efficacy to omeprazole-based therapy, and is well tolerated.

Topics: Adult; Aged; Amoxicillin; Clarithromycin; Double-Blind Method; Drug Therapy, Combination; Duodenal Ulcer; Enzyme Inhibitors; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole; Stereoisomerism

To determine the efficacy of once-daily esomeprazole plus antibiotics for eradication of Helicobacter pylori, to assess the effect of antibiotic resistance on eradication rate, and to define the rate of emergent resistance.. Three separate randomized trials were performed in H. pylori-positive patients with a duodenal ulcer or history of documented duodenal ulcer within 5 yrs: 1) esomeprazole (40 mg once daily), amoxicillin (1 g b.i.d.), and clarithromycin (500 mg b.i.d.; this combination will be referred to as EAC) versus esomeprazole (40 mg once daily) plus clarithromycin (500 mg twice daily; this combination will be referred to as EC); 2) EAC versus esomeprazole (40 mg once daily; E); and 3) EC versus E. Therapy was given for 10 days. Endoscopy and biopsies for CLOtest, histology, and culture with susceptibility testing were done at baseline and 4 wk after completion of therapy.. Per-protocol and intent-to-treat eradication rates, respectively, were as follows. For EAC versus EC in study 1 (N = 448), 84 versus 55% and 77 versus 52% (p < 0.001); for EAC versus E in study 2 (N = 98), 85 versus 5% and 78 versus 4% (p < 0.001); for EC versus E in study 3 (N = 66), 50% versus 0 and 46% versus 0 (p < 0.05). The 15% of patients in the combined studies with baseline clarithromycin resistance had significantly lower rates of eradication than those with susceptible strains (EAC: 45 vs. 89%; EC: 13 vs. 61%). Emergent resistance was less common after treatment with EAC [2/6 (33%)] than with EC (23/27 [85%]).. Ten-day triple therapy with once-daily esomeprazole plus twice-daily amoxicillin and clarithromycin achieves an eradication rate virtually identical to that of the twice-daily proton pump inhibitor-based triple therapies. Baseline clarithromycin resistance, present in 15% of patients, predicts a markedly decreased rate. Use of an amoxicillin-containing regimen may decrease emergence of clarithromycin resistance.

Topics: Adult; Amoxicillin; Clarithromycin; Double-Blind Method; Drug Administration Schedule; Drug Resistance, Microbial; Drug Therapy, Combination; Duodenal Ulcer; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Penicillin Resistance; Penicillins; Prospective Studies; Protein Synthesis Inhibitors; Proton Pump Inhibitors

Topics: Aged; Anti-Ulcer Agents; Body Mass Index; Duodenal Ulcer; Duodenitis; Esomeprazole; Humans; Hypertension, Portal; Ischemia; Liver Cirrhosis, Alcoholic; Male; Risk Factors; Stomach Ulcer; Treatment Outcome

Topics: Anemia, Iron-Deficiency; Animals; Cyclic GMP-Dependent Protein Kinase Type I; Duodenal Ulcer; Erythrocyte Indices; Erythrocytes; Esomeprazole; Feces; Gene Expression; Hemoglobins; Hemorrhage; Hepcidins; Humans; Iron; Iron Deficiencies; Isoenzymes; Mice; Mice, Knockout; Proton Pump Inhibitors; Reticulocyte Count; Reticulocytes

Topics: Diagnosis, Differential; Diarrhea; Digestive System Surgical Procedures; Duodenal Neoplasms; Duodenal Ulcer; Duodenum; Endoscopy, Digestive System; Esomeprazole; Fluid Therapy; Gastrinoma; Humans; Male; Middle Aged; Neoplasm Staging; Osmolar Concentration; Peptic Ulcer; Proton Pump Inhibitors; Rehydration Solutions; Tomography, Emission-Computed, Single-Photon; Tomography, X-Ray Computed; Treatment Outcome; Water-Electrolyte Balance

To assess rates of further bleeding, surgery and mortality in patients hospitalized owing to peptic ulcer bleeding.. Consecutive patients hospitalized for peptic ulcer bleeding and treated with a proton pump inhibitor (PPI) (esomeprazole or pantoprazole) were identified retrospectively in 12 centers in Spain. Patients were included if they had high-risk stigmata (Forrest class Ia-IIb, underwent therapeutic endoscopy and received intravenous PPI ≥120 mg/day for ≥24 h) or low-risk stigmata (Forrest class IIc-III, underwent no therapeutic endoscopy and received intravenous or oral PPI [any dose]).. Of 935 identified patients, 58.3% had high-risk stigmata and 41.7% had low-risk stigmata. After endoscopy, 88.3% of high-risk patients and 22.1% of low-risk patients received intravenous PPI therapy at doses of at least 160 mg/day. Further bleeding within 72 h occurred in 9.4% and 2.1% of high- and low-risk patients, respectively (p < 0.001). Surgery to stop bleeding was required within 30 days in 3.5% and 0.8% of high- and low-risk patients, respectively (p = 0.007). Mortality at 30 days was similar in both groups (3.3% in high-risk and 2.3% in low-risk patients).. Among patients hospitalized owing to peptic ulcer bleeding and treated with PPIs, patients with high-risk stigmata have a higher risk of further bleeding and surgery, but not of death, than those with low-risk stigmata.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Administration, Intravenous; Administration, Oral; Adult; Aged; Aged, 80 and over; Duodenal Ulcer; Endoscopy, Gastrointestinal; Esomeprazole; Female; Hemostasis, Endoscopic; Hospitalization; Humans; Male; Middle Aged; Pantoprazole; Peptic Ulcer Hemorrhage; Proton Pump Inhibitors; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Treatment Outcome

The two prevailing approaches to decrease risks of nonsteroidal anti-inflammatory drug (NSAID)-associated gastrointestinal (GI) events are the use of a COX-2 inhibitor or co-therapy with a proton-pump inhibitor (PPI). A major limitation of each approach is that, in patients at the highest risk for NSAID-induced ulcers, neither treatment is effective when used as a stand-alone strategy. An important question is whether combination therapy with a COX-2 inhibitor plus a PPI has improved GI safety compared to a traditional NSAID plus a PPI. This study evaluated high GI risk patients who were taking, along with their NSAID or COX-2 inhibitor, either the PPI, esomeprazole, or the placebo. It confirms that our current approach of adding PPIs to reduce NSAIDs' ulcer risks is an effective strategy. However, this study did not show a safety advantage for using a COX-2 inhibitor instead of a traditional NSAID in high GI risk patients who take PPIs. Thus, there continues to be no prospective data to support a GI benefit of COX-2 inhibitor plus a PPI over traditional NSAID plus a PPI in high-risk patients.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Cyclooxygenase 2 Inhibitors; Duodenal Ulcer; Esomeprazole; Humans; Proton Pump Inhibitors; Risk Factors; Stomach Ulcer

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Amoxicillin; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer; Esomeprazole; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Prospective Studies; Treatment Outcome

Esomeprazole is the last PPI registered on the Belgian market. It is the stable s-isomer of omeprazole. It has a better pharmacokinetic profile than omeprazole (racemate), allowing also better clinical performances. Esomeprazole is the first PPI shown superior to omeprazole in acute and chronic treatment of gastro-esophageal reflux disease. Controlled trials with this drug have also allowed to define new cost-effective strategies, such as on demand treatment for endoscopy-negative gastro-esophageal reflux and one week treatment of Helicobacter pylori positive duodenal ulcer.

Topics: Cost Control; Drug Costs; Duodenal Ulcer; Enzyme Inhibitors; Esomeprazole; Gastroesophageal Reflux; Helicobacter Infections; Humans; Omeprazole; Proton Pump Inhibitors

Topics: Anti-Ulcer Agents; Costs and Cost Analysis; Drug Approval; Drug Interactions; Duodenal Ulcer; Esomeprazole; Gastroesophageal Reflux; Humans; United States; United States Food and Drug Administration

Topics: Drug Therapy, Combination; Duodenal Ulcer; Esomeprazole; Helicobacter Infections; Helicobacter pylori; Humans