s-1743 and Dyspepsia

NSAIDs are widely prescribed for the treatment of pain, inflammation and rheumatic disorders, but their use is associated with adverse gastrointestinal effects, ranging from dyspeptic symptoms and peptic ulcers to more serious complications. Elderly patients are at high risk of experiencing NSAID-induced gastrointestinal tract injury and should be considered candidates for prophylactic pharmacological therapy. In studies conducted in adult patients, proton pump inhibitors (PPIs) such as esomeprazole have been shown to prevent or reduce NSAID-induced gastrointestinal injury. The beneficial effects of esomeprazole can be ascribed largely to its ability to maintain sustained inhibition of gastric acid secretion, although there is evidence to suggest that pharmacodynamic properties unrelated to acid inhibition may also contribute to the gastroprotective effects of this agent. Although there are limited data on the use of esomeprazole specifically in elderly patient populations, studies of patients at high risk of NSAID-induced gastrointestinal toxicity because of advanced age indicate that this PPI is both effective and well tolerated when administered in conjunction with NSAIDs. Thus, esomeprazole can be regarded as a useful option for prophylactic therapy in elderly patients receiving long-term NSAID therapy.

Topics: Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Dyspepsia; Esomeprazole; Gastric Acid; Gastrointestinal Diseases; Humans; Proton Pump Inhibitors; Risk Factors

Non-steroidal anti-inflammatory drugs (NSAIDs) represent one of the most widely used drug classes. However, many patients complain of dyspeptic symptoms impairing their quality of life: ~ 20% of patients taking NSAIDs show endoscopic ulcers with or without symptoms, and up to 2% of chronic NSAID users will develop serious complications each year, such as bleeding or perforation, which are the cause of death in many patients. Coprescription of a proton pump inhibitor is one established option for the healing and prevention of NSAID-associated lesions of the upper gastrointestinal tract in patients at risk. Recent studies evaluated the clinical efficacy of esomeprazole in the management of gastrointestinal problems associated with the intake of selective and non-selective NSAIDs and aspirin.

Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Dyspepsia; Esomeprazole; Humans; Proton Pump Inhibitors; Stomach Ulcer

This study investigated the safety and efficacy of fixed-dose combination tablets of naproxen/esomeprazole magnesium and nimesulide/pantoprazole to determine if both regimens are equally suited to relieve pain in patients with osteoarticular diseases and dyspeptic symptoms.. Patients were randomly assigned to receive either nimesulide/pantoprazole (100 mg/20 mg) twice daily or naproxen/esomeprazole magnesium (500 mg/20 mg) twice daily for 14 days. The primary endpoint was defined as the mean change in modified Western Ontario and McMaster Universities Osteoarthritis Index pain subscale. Secondary endpoints were mean visual analog scale score of dyspeptic symptoms (nausea, abdominal discomfort/pain, epigastric burning, postprandial fullness), mean visual analog scale score of individual dyspeptic symptoms, and individual score of dyspeptic symptoms according to patient diary. This study is registered at ClinicalTrials.gov: NCT01670552.. A total of 490 patients were enrolled and randomized, and 399 completed treatment (naproxen/esomeprazole, n=201; nimesulide/pantoprazole, n=198). The difference in mean change in the modified Western Ontario and McMaster Universities Osteoarthritis Index pain score after 7 days of treatment between the two treatment groups was 2.33 mm (95% CI, -1.22 to 5.89 mm). After 14 days of therapy, the difference was 0.45 mm (95% CI, -3.29 to 4.19 mm). The most common adverse events in the pooled group were abdominal discomfort, abdominal distention, dyspepsia, and nausea, but none of these was deemed to be clinically meaningful.. The present study demonstrated noninferiority of a 14-day regimen with a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for the treatment of osteoarticular pain.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Dose-Response Relationship, Drug; Double-Blind Method; Dyspepsia; Esomeprazole; Female; Humans; Male; Middle Aged; Naproxen; Osteoporosis; Pain; Pain Management; Pantoprazole; Sulfonamides; Tablets

To determine the sensitivity and specificity of the. One hundred and fourteen consecutive patients with dyspepsia, 53. The sensitivity of the. The new test meal based

Topics: Adult; Aged; Biopsy; Breath Tests; Carbon Isotopes; Dyspepsia; Esomeprazole; Female; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Prospective Studies; Proton Pump Inhibitors; Sensitivity and Specificity; Urea

Hypergastrinaemia induced by proton pump inhibitor (PPI) therapy may cause ECL-cell and parietal-cell hyperplasia and rebound hyperacidity and dyspepsia after PPI withdrawal. The aim of the study was to assess the effect of different dosage-regimens of netazepide, a gastrin/CCK. Six groups of eight healthy subjects participated in a randomised, double-blind study of esomeprazole 40 mg daily for 28 days, in combination with netazepide 1, 5 or 25 mg or placebo, daily, during the last 14 days of esomeprazole or during 14 days after treatment withdrawal. Fasting serum gastrin and plasma CgA were measured during treatment and after withdrawal, as biomarkers of acid suppression and ECL-cell activity, respectively. Dyspepsia was monitored throughout the study.. Esomeprazole increased gastrin and CgA. Netazepide increased gastrin, but not CgA, and inhibited dose dependently the CgA response to esomeprazole. Gastrin and CgA returned to baseline within 2-3 days of esomeprazole withdrawal; netazepide did not shorten that time. There was no rebound dyspepsia after esomeprazole withdrawal.. Esomeprazole and netazepide each increase gastrin, consistent with a secondary effect of gastric acid suppression, but by different mechanisms. Esomeprazole-induced hypergastrinaemia stimulates ECL cells and thereby increases CgA. Netazepide-induced hypergastrinaemia does not increase CgA, because netazepide blocks gastrin/CCK

Topics: Adult; Aged; Anti-Ulcer Agents; Benzodiazepinones; Chromogranin A; Double-Blind Method; Dyspepsia; Esomeprazole; Female; Gastric Acidity Determination; Gastrins; Humans; Male; Middle Aged; Phenylurea Compounds; Proton Pump Inhibitors; Receptor, Cholecystokinin B; 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

Currently only a few studies compare sequential and concomitant non-bismuth Helicobacter pylori therapies referring to high antibiotic resistance populations.. This multicenter prospective randomized clinical trial included 353 H. pylori positive, treatment naïve, patients. All patients had positive CLO-test and/or histology and culture. They received sequential (esomeprazole 40mg, amoxicillin 1g/bid for 5days, followed by 5days of esomeprazole 40mg, clarithromycin 500mg and metronidazole 500mg bid), or concomitant treatment (all drugs taken concomitantly bid for 10days). Eradication was confirmed by (13)C-urea breath test or histology 4-6weeks after treatment. Adverse events and adherence were evaluated.. Allocated to concomitant were 175 (72F/103M, mean 52.3years, 38.3% smokers, 25.7% ulcer disease) and 178 (87F/91M, mean 52years, 31% smokers, 19.1% ulcer disease) patients to sequential treatment. There were 303/353 (85.8%) positive cultures, with the following resistances: 34% metronidazole, 27.7% clarithromycin, and 7.9% dual. Eradication rates were, respectively, 89.1% (156/175) vs. 78.7% (140/178) by intention to treat (p=0.01, 95% CI=2.7-18) and 93.4%(156/167) vs. 82.8% (140/169) per protocol (p=0.004, 95% CI=3.6-17.6). Overall, adherence was (98.9%, 95% CI=97-100). Eradication rates according to resistance were the following: dual susceptible strains 67/69 (97.1%), 62/67 (92%) (p=0.4), metronidazole single resistant 38/39 (97.4%), 31/39 (79.5%) (p=0.03, 95% CI=3.5-33), clarithromycin single resistant 25/28 (89.3%), 26/31 (83.9%) (p=0.8), and dual resistant 9/12 (75%), 4/11 (36.4%) (p=0.1) for concomitant and sequential regimens, respectively. Side effects were comparable among regimens, except from diarrhea being more frequent among patients treated with concomitant treatment.. Concomitant treatment eradication rate overcomes 90% per protocol and has a significant advantage over sequential therapy. This is probably due to its better efficacy on metronidazole resistant strains. Both regimens were well tolerated and safe.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Biopsy; Breath Tests; Carbon Isotopes; Clarithromycin; Drug Resistance, Bacterial; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Peptic Ulcer; Proton Pump Inhibitors; Pyloric Antrum; Urea

Therapy for functional dyspepsia remains a challenge. This study aimed to evaluate esomeprazole (E) versus placebo (P) regarding (1) the effectiveness in providing relief of abdominal pain or discomfort during 16 weeks of therapy in patients with functional dyspepsia having moderate or severe symptoms; (2) the effects on gastric acid suppression and (3) the relationship between symptom relief and gastric pH.. Enrolled patients were randomized to E (n = 38) or P (n = 35) in a double-blind, placebo-controlled trial. Outcomes were measured at four 4-week intervals. Drug dose titrated at each visit, based on relief of abdominal symptoms. The 24-hour gastric pH was monitored at baseline, 4 and 8 weeks.. After 4 weeks, 71% of E patients (40mg) reported satisfactory symptom relief versus 34% of P patients (P < 0.001). When the dose for nonresponders (NR) was titrated to 40mg twice daily, the E relief rate increased to 82% versus 56% in P group (P < 0.05). During the next 4 weeks, with dose decreased by half in responders, E response rate declined to 69% versus 48% in P group (P < 0.10). When the dose was increased for NR during the last 4 weeks, E rate increased to 83% versus 57% in P group (P < 0.05). At 4 and 8 weeks for E responders and NR, patients׳ pH >4 value increased significantly compared to baseline.. (1) Though E 40mg once daily is superior to P, some patients benefit from 40mg twice daily; (2) E, 40mg once daily, profoundly inhibits gastric acid secretion; (3) intragastric pH monitoring before and after therapy may help address the relationship between symptomatic relief and gastric acid secretion and (4) some patients respond to monitored titrated placebo therapy.

Topics: Adolescent; Adult; Double-Blind Method; Dyspepsia; Esomeprazole; Esophageal pH Monitoring; Female; Gastric Juice; Humans; Male; Middle Aged; Proton Pump Inhibitors; Treatment Outcome; Young Adult

Functional dyspepsia (FD) is a gastroduodenal disorder that presents as postprandial fullness, early satiation, or epigastric burning despite no evidence of a structural disease. Proton pump inhibitors (PPIs) are often the first choice for treating FD. However, some patients need additional medication because of residual symptoms despite a certain level of benefit from the PPI. For these patients, a combination of PPI and other agents has a possibly more beneficial effect than changing their medication. This study aimed to evaluate the efficacy of an initial PPI followed by combination therapy with PPI and acotiamide in FD patients with residual symptoms after an initial PPI. We enrolled 105 patients who started an initial PPI (20 mg of esomeprazole once a day). Twenty-three patients with residual symptoms received 100 mg of acotiamide, a cholinesterase inhibitor, three times a day with esomeprazole as a combination therapy for 2 weeks. The symptoms were evaluated using the modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (mFSSG). Eighteen of 23 patients (78%) achieved an overall improvement in symptoms. Almost all FD-related symptoms statistically improved after the combination therapy, with an improvement in the mFSSG score relevant to the postprandial distress syndrome and epigastric pain syndrome. The symptoms improved regardless of age, sex, and the pre-combination therapy score of the mFSSG. Our findings suggest that the combination therapy of acotiamide and PPI may be effective in selected FD patients with insufficient improvement with an initial PPI. However, well-designed trials are required to confirm the efficacy.

Topics: Benzamides; Drug Resistance; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Proton Pump Inhibitors; Thiazoles; Treatment Outcome

Although low-dose acetylsalicylic acid (ASA) is recommended for prevention of cardiovascular events in at-risk patients, its long-term use can be associated with the risk of peptic ulcer and upper gastrointestinal (GI) symptoms that may impact treatment compliance. This prespecified secondary analysis of the OBERON study (NCT00441727) determined the efficacy of esomeprazole for prevention/resolution of low-dose ASA-associated upper GI symptoms. A post hoc analysis of predictors of symptom prevention/resolution was also conducted. Helicobacter pylori-negative patients taking low-dose ASA (75-325 mg) for cardiovascular protection who had ≥1 upper GI risk factor were eligible. The patients were randomized to once-daily esomeprazole 40 mg, 20 mg, or placebo, for 26 weeks; 2303 patients (mean age 67.6 years; 36% aged >70 years) were evaluable for upper GI symptoms. The proportion of patients with dyspeptic or reflux symptoms (self-reported Reflux Disease Questionnaire) was significantly lower (P < 0.0001) in those treated with esomeprazole versus in those treated with placebo. Treatment with esomeprazole (P < 0.0001), age >70 years (P < 0.01), and the absence of upper GI symptoms at baseline (P < 0.0001) were all factors associated with prevention/resolution of upper GI symptoms. Together, these analyses demonstrate that esomeprazole is effective in preventing and resolving patient-reported upper GI symptoms in low-dose ASA users at increased GI risk.

Topics: Age Factors; Aged; Anti-Ulcer Agents; Aspirin; Cardiovascular Diseases; Dose-Response Relationship, Drug; Double-Blind Method; Dyspepsia; Esomeprazole; Female; Gastroesophageal Reflux; Gastrointestinal Diseases; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Risk Factors; Secondary Prevention; Self Report; Upper Gastrointestinal Tract

Lost productivity accounts for a significant part of the costs caused by gastrointestinal symptoms. We aimed to describe selfreported productivity in patients presenting with dyspepsia.. Data were sourced from a randomized, double-blinded study of two weeks of esomeprazole 40 mg or placebo in 805 primary-care patients with uninvestigated dyspepsia. Work productivity was tested using the Work Productivity and Activity Impairment questionnaire. Treatment effect on work productivity loss was tested according to the likelihood of treatment response.. A total of 401/805 employed patients were included in the analysis. The average work productivity loss in the past seven days was 10.5 working hours/week. The productivity loss grew with increasing severity of symptoms at baseline. Following two weeks of treatment, the mean improvement in work productivity was significantly higher for both absenteeism (1 hour versus 0.1 hour, p < 0.05) and presenteeism (5.3 hours versus 4.3 hours, p < 0.05) in patients treated with esomeprazole versus placebo. The most substantial improvement was seen in patients who, based on baseline symptoms, were assessed to be likely treatment responders.. Dyspepsia symptoms represent a significant economic burden in terms of lost productivity. The RESPONSE algorithm is successful in determining which patients will benefit from acid suppression in terms of enhanced productivity.

Topics: Absenteeism; Adult; Anti-Ulcer Agents; Cost of Illness; Double-Blind Method; Dyspepsia; Efficiency; Esomeprazole; Female; Humans; Male; Middle Aged; Self Report; Severity of Illness Index; Work

Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable.. To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment.. Eight hundred and five uninvestigated, primary care patients with upper GI symptoms that were considered to be acid-related were randomised to 2 weeks' treatment with esomeprazole 40 mg or placebo. The study population was divided into a model sample (N = 484) and a validation sample (N = 321). We developed a therapeutic index to predict PPI response from the model sample and tested this in the validation sample.. Response to PPI was found in 68% of patients (44% in placebo arm). Bothersome heartburn and early satiety were associated with increased likelihood of PPI response, whereas dull abdominal pain, pain relieved by bowel movements and nausea in women were associated with a decreased likelihood of PPI response. Patients in the validation sample could be classified as having a 'very high' (n = 55), 'high' (n = 123), 'medium' (n = 78) or 'low' (n = 65) probability of PPI response. The therapeutic gains over placebo were 55%, 31%, 20% and 22%, respectively.. In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968).

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Dyspepsia; Esomeprazole; Female; Humans; Male; Middle Aged; Primary Health Care; Proton Pump Inhibitors; Regression Analysis; Treatment Outcome; Young Adult

Patients with dyspepsia often experience troublesome symptoms.. To assess the burden of uninvestigated dyspepsia (symptoms, health-related quality of life [HRQL] and work productivity) before and after 8 weeks' esomeprazole treatment.. Patients (n=1250) with uninvestigated dyspepsia (no endoscopy within 6 months and ≤ 2 endoscopies within 10 years) underwent a 1-week esomeprazole acid-suppression test before randomisation to 7 weeks' esomeprazole or placebo. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia (QOLRAD) and Work Productivity and Activity Impairment (WPAI) questionnaires were completed at baseline (1-week off-treatment) and 8 weeks. WPAI results were further analysed among patients who responded to the acid-suppression test.. The highest baseline symptom score was for the RDQ dyspepsia domain, and the highest disease burden was for QOLRAD vitality and food/drink problems. After 8 weeks, significant improvements vs. placebo were observed for all RDQ and QOLRAD domains. The sub-population of acid-suppression test responders, but not the total WPAI population, had a significant work productivity improvement vs. placebo.. Uninvestigated dyspepsia is associated with high symptom load and impacts on HRQL and work productivity. Esomeprazole improves HRQL among such patients, and improves work productivity among 1-week acid-suppression trial responders. ClinicalTrials.gov identifier: NCT00251992.

Topics: Adolescent; Adult; Anti-Ulcer Agents; Cost of Illness; Double-Blind Method; Dyspepsia; Esomeprazole; Humans; Middle Aged; Quality of Life; Regression Analysis; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome; Young Adult

BACKGROUND. Non-steroidal anti-inflammatory drugs are associated with poor upper gastrointestinal (UGI) tolerability and increased ulcer risk, but patient adherence to gastroprotective co-therapy is frequently inadequate. A fixed-dose combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg was evaluated: efficacy is reported by Hochberg et al. (Curr Med Res Opin 2011;27:1243-53); tolerability findings are reported here. PATIENTS AND METHODS. In two 12-week double-blind, placebo-controlled, multicenter, phase III studies (PN400-307 and PN400-309), patients aged ≥ 50 years with symptomatic knee osteoarthritis randomly (2:2:1) received naproxen/esomeprazole magnesium BID, celecoxib 200 mg QD, or placebo. Tolerability end-points included: modified Severity of Dyspepsia Assessment (mSODA); heartburn severity; and UGI adverse events (AEs). RESULTS. Overall, 619 (PN400-307) and 615 (PN400-309) patients were randomized; mSODA scores improved (baseline to week 12) in each group, with no significant treatment differences between naproxen/esomeprazole magnesium and celecoxib (95% CIs: PN400-307: -0.4, 1.9; PN400-309: -1.8, 0.6). Naproxen/esomeprazole magnesium-treated patients reported significantly more heartburn-free days versus celecoxib (95% CIs: PN400-307: 2.1, 12.7; PN400-309: 2.5, 13.4). UGI AE incidence (PN400-307: 17.3%; PN400-309: 20.3%) was similar between treatment groups. UGI AEs resulted in few discontinuations (< 4%, either study). CONCLUSIONS. Naproxen/esomeprazole magnesium has comparable UGI tolerability to celecoxib in patients with osteoarthritis.

Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Celecoxib; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Drug Combinations; Dyspepsia; Esomeprazole; Female; Gastrointestinal Tract; Heartburn; Humans; Male; Middle Aged; Naproxen; Osteoarthritis, Knee; Pyrazoles; Sulfonamides; Tablets, Enteric-Coated; Treatment Outcome

To determine whether strategies to counsel and empower patients with heartburn-predominant dyspepsia could improve health-related quality of life.. Using a cluster randomized, parallel group, multicentre design, nine centres were assigned to provide either basic or comprehensive counselling to patients (age range 18 to 50 years) presenting with heartburn-predominant upper gastrointestinal symptoms, who would be considered for drug therapy without further investigation. Patients were treated for four weeks with esomeprazole 40 mg once daily, followed by six months of treatment that was at the physician's discretion. The primary end point was the baseline change in Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire score.. A total of 135 patients from nine centres were included in the intention-to-treat analysis. There was a statistically significant baseline improvement in all domains of the QOLRAD questionnaire in both study arms at four and seven months (P<0.0001). After four months, the overall mean change in QOLRAD score appeared greater in the comprehensive counselling group than in the basic counselling group (1.77 versus 1.47, respectively); however, this difference was not statistically significant (P=0.07). After seven months, the overall mean baseline change in QOLRAD score between the comprehensive and basic counselling groups was not statistically significant (1.69 versus 1.56, respectively; P=0.63).. A standardized, comprehensive counselling intervention showed a positive initial trend in improving quality of life in patients with heartburn-predominant uninvestigated dyspepsia. Further investigation is needed to confirm the potential benefits of providing patients with comprehensive counselling regarding disease management.

Topics: Adolescent; Adult; Anti-Ulcer Agents; Cluster Analysis; Counseling; Directive Counseling; Dyspepsia; Esomeprazole; Female; Follow-Up Studies; Heartburn; Humans; Male; Middle Aged; Patient Advocacy; Patient Education as Topic; Physicians, Family; Practice Patterns, Physicians'; Primary Health Care; Quality of Life; Surveys and Questionnaires; Young Adult

Our study aimed to assess the effectiveness of esomeprazole or rabeprazole in combination with amoxicillin and clarithromycin for the eradication of Helicobacter pylori in Hong Kong non-ulcer dyspepsia (NUD) patients.. A prospective clinical trial was conducted at the Alice Ho Miu ling Nethersole Hospital outpatient endoscopy center from June 2004 to December 2005. Participants received amoxicillin 1 g, clarithromycin 500 mg, and, esomeprazole 20 mg (EAC) or rabeprazole 20 mg (RAC), all given twice daily for 1 week. The H. pylori status was determined by the [13C] urea breath test at least 4 weeks after completion of the treatment. Mutation status of CYP2C19 in exon 4 and exon 5 associated with the poor metabolizer phenotype was determined.. The intention-to-treat eradication rates in patients treated with RAC and EAC were 77% and 84.6% respectively, and per protocol-based eradication rates were 83.7% and 88.9% respectively. The eradication rates did not vary with CYP2C19 phenotype found. For clarithromycin-sensitive strains, the cure rates were statistically significant regardless of CYP2C19 polymorphism (P < 0.0001).. Triple therapy with either EAC or RAC is effective for Hong Kong Chinese NUD patients with H. pylori infection. Success eradication was related to clarithromycin resistance and not CYP2C19 genotype.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Aryl Hydrocarbon Hydroxylases; Asian People; Breath Tests; Clarithromycin; Cytochrome P-450 CYP2C19; Drug Resistance, Bacterial; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Hong Kong; Humans; Male; Middle Aged; Mutation; Pharmacogenetics; Polymorphism, Genetic; Prospective Studies; Rabeprazole; Urea

Rebound acid hypersecretion (RAHS) has been demonstrated after 8 weeks of treatment with a proton-pump inhibitor (PPI). If RAHS induces acid-related symptoms, this might lead to PPI dependency and thus have important implications.. A randomized, double-blind, placebo-controlled trial with 120 healthy volunteers was conducted. Participants were randomized to 12 weeks of placebo or 8 weeks of esomeprazole 40 mg/d followed by 4 weeks with placebo. The Gastrointestinal Symptom Rating Scale (GSRS) was filled out weekly. A score of >2 on 1 of the questions regarding heartburn, acid regurgitation, or dyspepsia was defined as a clinically relevant acid-related symptom.. There were no significant differences between groups in GSRS scores at baseline. GSRS scores for acid-related symptoms were significantly higher in the PPI group at week 10 (1.4 +/- 1.4 vs 1.2 +/- 0.9; P = .023), week 11 (1.4 +/- 1.4 vs 1.2 +/- 0.9; P = .009), and week 12 (1.3 +/- 1.2 vs 1.0 +/- 0.3; P = .001). Forty-four percent (26/59) of those randomized to PPI reported > or = 1 relevant, acid-related symptom in weeks 9-12 compared with 15% (9/59; P < .001) in the placebo group. The proportion reporting dyspepsia, heartburn, or acid regurgitation in the PPI group was 13 of 59 (22%) at week 10, 13 of 59 (22%) at week 11, and 12 of 58 (21%) at week 12. Corresponding figures in the placebo group were 7% at week 10 (P = .034), 5% at week 11 (P = .013), and 2% at week 12 (P = .001).. PPI therapy for 8 weeks induces acid-related symptoms in healthy volunteers after withdrawal. This study indicates unrecognized aspects of PPI withdrawal and supports the hypothesis that RAHS has clinical implications.

Topics: Adolescent; Adult; Double-Blind Method; Drug Administration Schedule; Dyspepsia; Esomeprazole; Female; Gastric Acid; Gastric Mucosa; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Reference Values; Severity of Illness Index; Time Factors; Treatment Outcome; Young Adult

The reflux disease questionnaire (RDQ) is a short, patient-completed instrument.. To investigate the psychometric characteristics of the RDQ in patients with heartburn-predominant (HB) and non-heartburn predominant (NHB) dyspepsia.. HB (n = 388) and NHB (n = 733) patients were randomized to esomeprazole 40 mg daily or twice daily for 1 week, followed by 3 weeks of esomeprazole 40 mg daily.. High factor loadings (0.78-0.86) supported the 'regurgitation' dimension of the RDQ. Overlapping factor loadings in the 'heartburn' and 'dyspepsia' dimensions suggested symptom overlap. All dimensions demonstrated high internal consistency (Cronbach's alpha: 0.79-0.90). Intra-class correlation coefficients over 4 weeks were good (0.66-0.85). The RDQ showed good responsiveness over 4 weeks of treatment, with high effect sizes (> or =0.80). Moderate or large symptom improvements were reported by 90% and 77% of HB and NHB patients, respectively, following treatment. Patients who responded to acid suppression also experienced symptom benefits in all RDQ dimensions.. The RDQ is reliable, valid and responsive to change in HB and NHB patients. The symptom overlap is important but need not play a major role in determining treatment strategy as both patient groups benefited from proton pump inhibitor treatment.

Topics: Adult; Anti-Ulcer Agents; Canada; Dyspepsia; Esomeprazole; Gastric Acid; Gastroesophageal Reflux; Heartburn; Humans; Male; Psychometrics; Surveys and Questionnaires

To evaluate the potential role of tegaserod in the management of functional dyspepsia (FD) and gastroesophageal reflux disease (GERD) in patients with chronic constipation and to determine the possible efficacy of tegaserod on solid-phase gastric emptying and gastric hypersensitivity.. This was an exploratory open-label trial of tegaserod therapy for dyspepsia and reflux symptoms in patients with chronic constipation. The study cohort consisted of 90 patients randomized to three treatment groups for a study period of 4 weeks (tegaserod 6 mg, twice daily; esomeprazole 40 mg, once daily; tegaserod 6 mg, twice daily plus esomeprazole 40 mg, once daily). Twenty healthy volunteers provided control values. Clinical symptoms were evaluated by one of the investigators using a Gastrointestinal Symptom Rating Scale (GSRS). Solid-phase gastric emptying and colonic transit were measured by the radiopaque barium marker method, and the water load test (WLT) was used to evaluate gastric sensation and the function of proximal stomach. The proportions of patients with complete relief of epigastric pain /discomfort, epigastric fullness, early satiety and heartburn in the tegaserod group and the tegaserod plus esomeprazole group were compared with the esomeprazole group, respectively.. The mean global gastrointestinal (GI) scores of all three treatment groups reported using the GSRS showed the same trend, with decreasing scores over the 4-week study period indicating a reported decreasing severity of symptoms that was significantly different from baseline values. Patients in the tegaserod plus esomeprazole group reported the lowest global GI scores after 4 weeks, as expected. Solid-phase gastric emptying (GER) and colonic transit (CTT) increased significantly in the tegaserod 6 mg twice daily group compared with baseline. These parameters did not change in the esomeprazole group at week 4 compared with baseline. In terms of gastric sensation, in the tegaserod group, the proportions of patients with hypersensitivity of the first perception threshold did not change at week 2 or week 4 compared with baseline; however, in this group and in the tegaserod plus esomeprazole group, the proportions of patients with hypersensitivity of discomfort threshold decreased significantly at week 4 compared with baseline. In the esomeprazole group, there were no changes in the proportions of patients with hypersensitivity of the first perception threshold and discomfort threshold at week 2 or 4 compared with baseline. No severe adverse events were recorded, and the medications were in general well-tolerated.. Tegaserod is effective and safe at improving dyspepsia and reflux symptoms in patients with chronic constipation, and tegaserod plus esomeprazole is superior to esomeprazole alone in the resolution of epigastric pain/discomfort and heartburn.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Anti-Ulcer Agents; Chronic Disease; Cohort Studies; Constipation; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Gastric Emptying; Gastroesophageal Reflux; Gastrointestinal Transit; Heartburn; Humans; Indoles; Male; Middle Aged; Serotonin 5-HT4 Receptor Agonists; Treatment Outcome

While empiric acid-suppressive therapy for uninvestigated dyspepsia patients with symptoms of epigastric pain or burning is standard practice, it is unknown whether an early response to therapy predicts outcome.. To evaluate whether a 1-w acid suppression trial is effective for predicting 8-w response in such patients.. Helicobacter pylori-negative patients (aged 18-50 years) in primary care with uninvestigated epigastric pain or burning were randomized to esomeprazole 40 mg q.d.s. or b.d. for 1w, followed by esomeprazole 40 mg q.d.s. or placebo for 7w. Each day, patients rated the severity of their symptoms.. Based on the last 3d, 1-w response rates were 39% (231 of 588) and 43% (258 of 596) with esomeprazole 40 mg q.d.s. and b.d., respectively. Based on the last 7d, response rates at 4w were 38% (283 of 738) and 25% (93 of 380) for esomeprazole and placebo, respectively, and 47% (339 of 716) and 34% (124 of 368), respectively, at 8w (both P < 0.001 vs. placebo). The sensitivity and specificity of esomeprazole treatment were 58% and 70%, respectively, at 8w.. A 1-w acid suppression trial is of limited clinical value for predicting 8-w response in patients with symptoms of epigastric pain or burning. Esomeprazole provides greater symptom control than placebo at 4w and 8w.

Topics: Administration, Oral; Adolescent; Adult; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Dyspepsia; Esomeprazole; Female; Heartburn; Humans; Male; Middle Aged; Placebos; Quality of Life; Treatment Outcome

Early identification of true responders to acid suppression in functional dyspepsia patients with symptoms of epigastric pain or burning may enable clinicians to optimally tailor treatment.. To evaluate whether a 1-w acid suppression trial is useful for identifying true responders in this population.. Patients (18-70 years) were randomized to either esomeprazole 40 mg q.d.s., b.d. or placebo for 1w, and then esomeprazole 40 mg q.d.s. or placebo for 7w. Epigastric pain and/or burning were recorded on a 4-point scale (0 = none, 3 = severe). Trial-week response was defined as symptom score sum < or = 1 on last 3d of therapy; response at 8w was symptom score sum < or = 1 over preceding 7d.. 1-w response rates were 33% (199 of 597), 29% (188 of 629) and 23% (71 of 315) with esomeprazole q.d.s., esomeprazole b.d. and placebo, respectively (P = 0.002 for esomeprazole groups vs. placebo). At 8w, trial week sensitivity and specificity were 46% and 80%, respectively, for esomeprazole (40 or 80 mg), and 33% and 87%, respectively, for placebo. The positive and negative predictive values for esomeprazole were 60% and 69%.. Response to a 1-w acid suppression trial is of limited use for predicting symptom response at 8w in patients with unexplained epigastric pain or burning.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Dyspepsia; Esomeprazole; Female; Follow-Up Studies; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Placebos; Quality of Life; Sensitivity and Specificity; Treatment Outcome

Midday and evening twice-a-day quadruple therapy appears to be the most effective therapy for Helicobacter pylori infection in Northern Sardinia, a site where antibiotics resistance is common.. The objective of our study was to estimate the efficacy, side-effects, and compliance of a quadruple therapy containing esomeprazole in a group of dyspeptic elderly patients.. Consecutive elderly patients positive for H. pylori infection and not previously treated for eradication were enrolled. Therapy consisted of esomeprazole 20 mg, tetracycline 500 mg, metronidazole 500 mg, and bismuth subcitrate tablets 240 mg, all twice-a-day with the midday and evening meals, for 10 days. Efficacy was evaluated using 13C-urea breath testing. Compliance was assessed after completing treatment and at follow up. Side effects were graded based on daily activities.. Ninety-five dyspeptic patients (range 65-81 years), 52 men and 43 women, were enrolled. The intention-to-treat cure rate was 91% (81 of 89; 95% CI = 88-99%) and, 95% (81 of 85; 95% CI = 83-96%) per-protocol analysis. Compliance was excellent. Mild-moderate side effects occurred in 27 patients.. Esomeprazole containing quadruple therapy was highly successful for initial eradication of H. pylori in elderly patients.

Topics: Aged; Aged, 80 and over; Anti-Bacterial Agents; Breath Tests; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Intestines; Male; Metronidazole; Nausea; Organometallic Compounds; Patient Compliance; Prospective Studies; Tetracycline

Triple therapy is the treatment of choice for Helicobacter pylori-infected patients with an eradication rate ranging from 70 to 85%. Poor compliance and antibiotic resistance are the main causes of treatment failure. The aim of the present study was to assess the efficacy of rifaximin, a poorly absorbed antibiotic, for H. pylori eradication.. We enrolled 48 consecutive H. pylori-positive patients affected. They were randomized to receive two 7-day rifaximin-based triple therapies: rifaximin tablets 400 mg t.i.d., esomeprazole 40 mg o.d. and clarithromycin 500 mg b.i.d. (CRE) or levofloxacin 500 mg o.d. (LRE). H. pylori eradication was assessed using a (13)C-urea breath test 4 weeks after the end of therapy. Treatment compliance and the incidence of side effects were also evaluated.. No dropouts were observed. The eradication rate both on intention-to-treat and per-protocol analysis did not show significant differences between groups: 58% (14/24 patients) in group 1 and 42% (10/24 patients) in group 2 (p = 0.24, OR 1.96, 95% CI 0.62-6.18). No significant differences in patients' compliance and incidence of side effects were found between groups.. Rifaximin-based therapy showed optimal compliance but a limited eradication rate compared to standard first-line treatment. Further investigations are needed to evaluate different dosages and combinations.

Topics: Adolescent; Adult; Aged; Anti-Infective Agents; Clarithromycin; Drug Therapy, Combination; Dyspepsia; Enzyme Inhibitors; Esomeprazole; Female; Follow-Up Studies; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Pilot Projects; Rifamycins; Rifaximin; Treatment Outcome

The etiologies of functional dyspepsia (FD) are unclear, but in some studies, treatment with a proton pump inhibitor has been beneficial. The objective of this study was to evaluate the efficacy of esomeprazole 40 mg once a day compared to placebo in achieving symptom relief in primary care patients with FD.. This was a randomized, placebo-controlled trial in adult FD patients, who had at least moderate severity of symptoms, defined as a score of > or =4 on a 7-point Global Overall Symptom (GOS) scale. Patients were excluded if they had predominant symptoms of heartburn or regurgitation; after a normal baseline endoscopy, patients were randomized to esomeprazole 40 mg once daily or placebo for 8 wk. The primary outcome measure was symptom relief (GOS < or =2) at 8 wk.. Of the 502 enrolled patients, 224 were randomized. The main reasons for exclusion were abnormal endoscopic findings, especially esophagitis. A significantly greater proportion of patients in the esomeprazole group achieved symptom relief at 4 but not at 8 wk compared to placebo: 4 wk esomeprazole 50.5% versus placebo 32.2%, p= 0.009; 8 wk esomeprazole 55.1% versus placebo 46.1%, p= 0.16. A similar relationship at 4 and 8 wk was seen for symptom resolution (GOS = 1) and improvement (DeltaGOS > or =2).. For the primary outcome measure of symptom relief at 8 wk, there was no statistically significant difference between esomeprazole 40 mg once a day and placebo. However, at 4 wk, esomeprazole was significantly more effective than placebo for symptom relief. The difference in therapeutic gain between 4 and 8 wk was largely due to a higher placebo response rate at 8 wk.

Topics: Administration, Oral; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Dyspepsia; Endoscopy, Gastrointestinal; Esomeprazole; Female; Follow-Up Studies; Humans; Male; Middle Aged; Quality of Life; Severity of Illness Index; Treatment Outcome

Standard anti-Helicobacter pylori therapy may not achieve a satisfactory eradication rate. Fluoroquinolones, such as moxifloxacin, are safe and promising agents for H. pylori eradication.. To compare the efficacy of two 1-week moxifloxacin-based H. pylori eradication regimens with two standard treatments.. Three hundred and twenty H. pylori-positive subjects were randomized into four groups to receive: moxifloxacin, amoxicillin, esomeprazole (Group MAE); moxifloxacin, tinidazole and esomeprazole (Group MTE); standard triple therapies with clarithromycin, amoxicillin and esomeprazole (Group CAE) or tinidazole (Group CTE) for 7 days. H. pylori status was re-assessed 6 weeks after the end of therapy by 13C urea breath test.. Three hundred and twenty patients completed the efficacy analysis per protocol; H. pylori eradication rate in group MTE was 90% (72 of 80) and 92% (72 of 78), in group MAE was 88% (70 of 80) and 89%, (70 of 79) in Group CAE was 73% (58 of 80) and 78% (58 of 74), and in Group CTE was 75% (60 of 80) and 79% (60 of 76), respectively, in intention-to-treat and in per protocol analyses. Eradication rates of moxifloxacin-based triple therapies were significantly higher than that observed using standard triple schemes. The incidence of side effects was significantly lower in moxifloxacin groups than in control groups.. Seven-day moxifloxacin-based triple therapies provide optimal eradication rates with a good compliance when compared with the standard triple therapy schemes.

Topics: Adult; Amoxicillin; Aza Compounds; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Fluoroquinolones; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Moxifloxacin; Patient Compliance; Prospective Studies; Quinolines; Tinidazole; Treatment Outcome

The proton pump inhibitor (PPI)-based 7-day triple therapy is the regimen with the highest cure rates for eradication of Helicobacter pylori infection and has been recommended as the first-line regimen in the world. It had been reported that a 1-day quadruple therapy could also successfully cure 95% of the H. pylori infected patients.. To observe the efficacy of 1-day high-dose quadruple therapy versus 7-day triple therapy for treatment of H. pylori infection, and to observe side-effects of the two different regimens.. This randomized, open, parallel-controlled study was conducted at Renji Hospital between November 2004 to March 2005. A total of 80 consecutive patients with non-ulcer dyspepsia, who were H. pylori positive proven by both rapid urease test and histology were included and randomly assigned to 1-day quadruple therapy or 7-day triple therapy. Thirty-nine patients were administered with 1-day high-dose quadruple therapy including esomeprazole 40 mg b.i.d., colloidal bismuth subcitrate 440 mg q.i.d., amoxicillin 2 g q.i.d. and metronidazole (400 mg q.i.d.) for 1 day. Forty-one patients received a standard 7-day triple therapy consisting of esomeprazole 20 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1 g b.i.d. for 7 days. The eradication rates were evaluated by the (13)C-urea breath test at least 4 weeks after completion of a course treatment.. Seventy-seven patients completed the trial and three patients dropped out. The eradication rates in the 1-day therapeutic group and the 7-day therapeutic group were 39.5% (15/38) and 84.6% (33/39), respectively. There was a statistically significant difference between the two groups (P < 0.0001). Short-lasting and self-limiting side effects including thirst, a metallic taste, diarrhea and abdominal pain were reported in three patients (7.9%) in the 1-day group and seven patients (18%) in the 7-day group (P = 0.31).. A 1-day high-dose quadruple therapy with amoxicillin, metronidazole, bismuth salt, and esomeprazole is not effective for eradication of H. pylori compared with the standard 7-day triple therapy.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Breath Tests; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Organometallic Compounds; Proton Pump Inhibitors

Topics: Acetaminophen; Adult; Cross Reactions; Diagnosis, Differential; Drug Hypersensitivity; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Humans; Proton Pump Inhibitors; Skin Tests

The prevalence of gastroesophageal reflux disease (GERD) symptoms has not been investigated in patients on maintenance hemodialysis in Japan, and few studies have reported the effect of proton pump inhibitors (PPIs) in hemodialysis patients with GERD symptoms. Here, we investigated the prevalence of GERD symptoms and the effects of the PPI esomeprazole on the quality of life related to reflux and dyspepsia in patients on maintenance hemodialysis.. This was a cross-sectional/cohort study of hemodialysis outpatients implemented in 10 Japanese medical facilities from October 2012 to March 2014. The trial was registered in the UMIN Clinical Trial Registry (UMIN000009124).. Forty-one of 385 patients (11%) reported GERD symptoms on the Global Overall Symptom (GOS) questionnaire. Multivariate logistic regression analysis identified the independent prognostic factors for GERD symptoms as a history of gastric ulcer and use of sevelamer hydrochloride or calcium polystyrene sulfonate. Participants with GERD symptoms completed the Quality of Life in Reflux and Dyspepsia, Japanese version (QOLRAD-J) questionnaire and were assigned to receive 4-week esomeprazole treatment (20 mg/day). This PPI therapy significantly improved all QOLRAD-J domains in the full analysis set (n = 28) and improved the GERD symptoms listed in the GOS questionnaire. Significantly impaired disease-specific quality of life (QOL) in the QOLRAD-J domains was observed in 44.4-74.1% of patients who had symptoms before treatment. The mean GOS and QOLRAD-J scores correlated significantly.. Therapy with 20 mg/day esomeprazole appears to be efficacious for improving disease-specific QOL and GERD symptoms in Japanese patients on maintenance hemodialysis.

Topics: Adult; Aged; Aged, 80 and over; Cross-Sectional Studies; Dyspepsia; Esomeprazole; Female; Gastroesophageal Reflux; Humans; Japan; Kidney Diseases; Logistic Models; Male; Middle Aged; Multivariate Analysis; Prevalence; Proton Pump Inhibitors; Quality of Life; Remission Induction; Renal Dialysis; Surveys and Questionnaires; Time Factors; Treatment Outcome

Quadruple concomitant non-bismuth therapy has recently become the most widely prescribed first-line treatment for Helicobacter pylori infection in Spain. Whether optimized conventional triple therapy can achieve comparable efficacy rates remains to be seen.. Retrospective study comparing the efficacy of triple and quadruple concomitant therapy, and sub-analysis following administration of both for 10 days with esomeprazole 40mg/12h.. A first-line therapy was administered to 657 patients from 1st January 2012 to 31st December 2014. Quadruple therapy (n=371) showed higher efficacy than triple therapy (n=248) for both intention-to-treat (85.9% vs. 65.7%; P<.001) and per protocol analysis (92.5% vs. 68.4%; P<.001). When both therapies included esomeprazole 40mg/12h administered for 10 days, quadruple concomitant therapy (n=108) also had higher efficacy than triple therapy (n=76) for intention-to-treat (90.7% vs. 73.6%; P=.003) and per protocol analysis (92.5% vs.74.6%; P=.002).. Quadruple concomitant therapy with high dose proton pump inhibitor (PPI) for 10 days achieves a significantly higher eradication outcome than optimized triple therapy, with rates of over 90% when the PPI prescribed is esomeprazole 40mg/12h.

Topics: Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Clarithromycin; Drug Administration Schedule; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Gastritis; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Proton Pump Inhibitors; Retrospective Studies; Spain; Stomach Ulcer

Functional dyspepsia is thought to be a diagnosis made after excluding endoscopically detectable lesions by the current Rome III criteria. However, whether these "functional dyspepsia" patients were diagnosed appropriately is still controversial.. A total of 223 patients diagnosed with functional dyspepsia by Rome III criteria were enrolled. All patients were submitted to endoscopic examination, rapid urease test, and histologic evaluation. We also appraised the effect of a 7-day treatment based on the Glasgow Dyspepsia Severity Score.. Helicobacter pylori infection and neutrophil infiltration were found in 37.7% and 36.3% cases, respectively, and were both more frequent in the subgroup with epigastric pain symptom (EPS) than in the other two subgroups. In addition, neutrophil infiltration was more common and severe in the H. pylori-positive individuals than in the patients without infection (Mann-Whitney U-test = 431.500, p < .001). The treatment was useful in symptom improvement of all three subgroups, and the EPS subgroup had the greatest change of symptom scores before and after treatment as compared with the subgroup with postprandial distress symptom (PDS) and PDS/EPS subgroup (χ(2) = 42.745, p < .001), and the eradication of H. pylori revealed a statistical significant difference in different subgroups (χ(2) = 11.300, p = .001).. Our findings showed that many H. pylori-positive subjects diagnosed as "functional dyspepsia" were actually chronic gastritis patients, especially the EPS cases who are more likely to be patients with "active gastritis under microscope," and also benefit most from the treatment of proton-pump inhibitors or eradication of H. pylori.

Topics: Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Gastritis; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Male; Neutrophil Infiltration

Topics: Aged; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Biopsy; Clarithromycin; Drug Therapy, Combination; Dyspepsia; Endoscopy, Gastrointestinal; Esomeprazole; Female; Gastritis; Granuloma; Helicobacter Infections; Helicobacter pylori; Humans; Symptom Assessment; Treatment Outcome

Up to 40% of patients with gastroesophageal reflux disease fail to respond to proton pump inhibitor therapy.. To determine predictors of clinical response of proton pump inhibitor therapy.. Consecutive patients with gastroesophageal reflux disease were enrolled prospectively. All patients underwent upper endoscopy and 24-h multichannel intraluminal impedance and pH monitoring before receiving esomeprazole 20 mg b.i.d. for 2 months. Multivariate logistic regression analysis was used to determine the independent predictors of clinical response to proton pump inhibitor therapy.. A total of 204 patients with typical reflux symptoms were recruited and screened. Among them 153 patients (mean age 46.3 ± 10.6 years, 51.0% female) completed all the examinations and were assigned to proton pump inhibitor therapy. Ninety-five patients (62.1%) responded to acid suppression after 2 months. Multivariate logistic analysis showed that the predictor for response was pathological distal esophageal acid reflux (P = 0.001). The factors associated with proton pump inhibitor therapy failure were the presence of irritable bowel syndrome alone (P = 0.006), depression (P = 0.005), and overlap of irritable bowel syndrome and functional dyspepsia (P = 0.002).. The clinical response of acid suppression on gastroesophageal reflux disease could be predicted by clinical and pH parameters rather than impedance data.

Topics: Adult; Asian People; China; Depression; Dyspepsia; Esomeprazole; Esophageal pH Monitoring; Female; Gastroesophageal Reflux; Humans; Irritable Bowel Syndrome; Male; Middle Aged; Multivariate Analysis; Proton Pump Inhibitors; Treatment Failure

Conflicting results have been reported whether patients with non-ulcer dyspepsia (NUD) respond differently to Helicobacter pylori (H. pylori) eradication treatment compared with patients with peptic ulcer diseases (PUD). The aim of this study was to evaluate any difference in H. pylori eradication rates between patients with NUD and PUD according to each proton pump inhibitor (PPI).. From September, 2004 to April, 2007, we retrospectively reviewed 2,297 patients with NUD (1,050 patients) or PUD (1,247 patients) infected with H. pylori. All patients received a standard 1 week triple therapy comprising of one of the five PPIs (pantoprazole, esomeprazole, omeprazole, lansoprazole, rabeprazole), clarithromycin and amoxicillin. The follow-up H. pylori test was performed 4 weeks after the completion of therapy.. There was no significant difference in the eradication rates between the two groups. In comparison of eradication rates according to PPI, omeprazole- based triple therapy group showed higher eradication rate than other groups in patients with NUD, but not in patients with PUD.. This study failed to show any difference in H. pylori eradication rate between patients with NUD and PUD. There is no convincing evidence that the eradication rate may be affected by different PPI.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Clarithromycin; Data Interpretation, Statistical; Drug Therapy, Combination; Dyspepsia; Enzyme Inhibitors; Esomeprazole; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Middle Aged; Omeprazole; Pantoprazole; Peptic Ulcer; Proton Pump Inhibitors; Rabeprazole

Data on Asian patients who present to primary care physicians with dyspepsia are limited.. To determine predictors of response to a trial of proton pump inhibitor therapy.. One hundred ninety patients presenting to their general practitioners with dyspeptic symptoms but without alarm symptoms, underwent endoscopy and were subsequently treated with 20 mg of esomeprazole twice a day for 2 weeks. Possible predictors of response were assessed before treatment. Dyspeptic symptoms were scored at baseline and at the end of treatment. Excellent response and poor response were defined as end of treatment score of or=50% reduction in symptom scores.. On bivariate analysis male sex and having 2 dyspeptic symptoms, anxiety, and irritable bowel syndrome predicted poor response. On multivariate analysis, male sex and

Topics: Adult; Aged; Asian People; Dyspepsia; Esomeprazole; Female; Humans; Male; Middle Aged; Predictive Value of Tests; Primary Health Care; Prospective Studies; Proton Pump Inhibitors; Severity of Illness Index; Treatment Outcome

Oesophageal acidification induces dyspeptic symptoms in healthy individuals. This study aimed to evaluate the correlation between oesophageal acid exposure and dyspeptic symptoms in patients with nonerosive reflux disease.. A total of 68 patients with dominant symptoms of heartburn, negative upper gastrointestinal endoscopy and concomitant dyspeptic symptoms participated in the study. The severity of dyspepsia and reflux-related symptoms was evaluated, and 24-h gastro-oesophageal pH-monitoring study was performed in all patients at baseline and after 4 weeks of therapy with esomeprazole 40 mg.. Oesophageal basal acid exposure was pathological in 43 patients and normal in 25 patients, with a similar prevalence and severity of individual dyspeptic symptoms in the two groups. A significant correlation between reflux and dyspepsia scores was observed in the subgroup of patients with normal, but not in those with abnormal pHmetry (r=0.4, P=0.04 and r=0.2 P=0.07, respectively). After esomeprazole, a reduction in severity of dyspepsia (>or=50% with respect to baseline) was observed, independent of improvement of reflux-associated symptoms. Improvement in dyspepsia was, however, similar in patients with normal and abnormal basal acid exposure (14/25 vs. 33/43, respectively, P=NS).. Dyspeptic symptoms coexist in a subset of nonerosive reflux disease patients, but prevalence and severity of the symptoms seems to be independent of oesophageal acid exposure.

Topics: Anti-Ulcer Agents; Dyspepsia; Esomeprazole; Esophageal pH Monitoring; Female; Gastric Acid; Gastroesophageal Reflux; Humans; Male; Middle Aged; Proton Pump Inhibitors; Treatment Outcome

Esomeprazole, the S-isomer of omeprazole, was launched in the UK in September 2000. The first proton pump inhibitor, omeprazole, has been marketed in the UK for over 10 years. However, the adverse event database of newly marketed drugs is limited, and it is only after widespread clinical use that the adverse effect profile of a drug is ascertained more comprehensively. This study aims to monitor the safety of esomeprazole prescribed in the primary care setting in England using prescription-event monitoring (PEM).. A postmarketing surveillance study using the observational cohort technique of PEM. Patients were identified from dispensed prescriptions for esomeprazole issued by general practitioners between September 2000 and April 2001. Questionnaires ('green forms') requesting clinical event data on these patients were sent to prescribers approximately 6 months after the date of the first dispensed prescription for each individual patient. Incidence densities (IDs), expressed as the number of first reports of an event/1000 patient-months of exposure (PME), were calculated. Significant differences between IDs for events reported in the first month (ID1) and the following 5 months (ID2-6) of exposure were regarded as potential signals. Other methods for signal detection such as medical evaluation of selected events and evaluation of reasons for stopping were also applied.. Green forms containing clinically useful information for 11 595 patients (median age 56 years; 53.2% female) were received. Diarrhoea was the event with the highest ID1 in month 1 (8.0 per 1000 patient months of exposure). Adverse events that occurred significantly more often in the first month of treatment with esomeprazole compared with months 2-6 included diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, headache/migraine, intolerance, malaise/lassitude, pruritus, unspecified adverse effects and abnormal sensation.. The safety profile of esomeprazole was consistent with the prescribing information and experience reported in the literature.

Topics: Adverse Drug Reaction Reporting Systems; Cohort Studies; Diarrhea; Drug Monitoring; Dyspepsia; England; Esomeprazole; Esophageal Diseases; Female; Humans; Male; Middle Aged; Omeprazole; Primary Health Care; Product Surveillance, Postmarketing; Proton Pump Inhibitors

Patients with gastro-oesophageal reflux disease may complain of epigastric pain, bloating, early satiety, epigastric fullness, epigastric burning, nausea and vomiting.. To evaluate the symptoms in response to gastric distension and its relationship to a therapeutic course in patients with gastro-oesophageal reflux disease using the water load test, compared to healthy controls.. Thirty gastro-oesophageal reflux disease patients with grade A oesophagitis (studied before and after 4 weeks of therapy with esomeprazole, 40 mg per day) and 15 patients with reflux-related symptoms demonstrated at wireless pH monitoring (non-erosive reflux disease) were compared to 30 healthy volunteers.. Patients with grade A oesophagitis and with reflux-related symptoms ingested significantly lower water volumes than did controls, before onset of fullness, without statistically significant difference between erosive or non-erosive gastro-oesophageal reflux disease; this variable improved in patients after treatment. Nausea scores were higher basally in patients, pre- and post-therapy, and improved after therapy. Thirty-minute fullness and bloating scores improved after therapy in all gastro-oesophageal reflux disease patients compared to controls and pre-therapy. In all pre-treatment patients, a significant correlation was found only with epigastric fullness; after treatment, there was no significant relationship between the water load and the symptom scores.. In patients with reflux-related symptoms, with or without grade A oesophagitis, the water load test is frequently abnormal, suggesting an altered gastric function. This could explain the incomplete resolution of symptoms after treatment in some patients, and should lead to additional studies aimed at exploring gastric function in gastro-oesophageal reflux disease patients.

Topics: Adult; Drinking; Dyspepsia; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Treatment Outcome; Water

Topics: Acute Disease; Anti-Inflammatory Agents; Anti-Ulcer Agents; Dyspepsia; Esomeprazole; Female; Hematuria; Humans; Male; Methylprednisolone; Middle Aged; Nausea; Nephritis, Interstitial; Prednisone; Proton Pump Inhibitors; Vomiting

The aim was to evaluate the incidence of Helicobacter pylori (HP) infection in Greenland, to assess the value of the test "Helicobacter antigen in faeces" as a diagnostic tool and to determine the level of antibiotic resistance.. 100 consecutive patients with dyspepsia who visited for endoscopic gastric examination were included. The patients had to be born in Greenland and to be > or = 18 years old.. Samples for HP antibody in blood, HP antigen in faeces, urease test on biopsies were collected from the patients. Gastric biopsies were cultured for HP bacteria, and antibiotic resistance was tested. Patients with positive urease test and/or antigen in faeces and/or positive culture were treated simultaneously with Amoxicillin, Metronidazole and Esomeprazole for 1 week. Patients with duodenal or gastric ulcer were endoscopically re-examined 8 weeks later. Patients with proven HP infection but without ulcer submitted a faeces sample 8 weeks after the eradication.. 77 patients were considered HP infected, and received treatment. Only 32% of them were eradicated sufficiently.. HP antigen in faeces test is useful as a diagnostic tool and for control of therapy. A change in strategy of HP treatment in Greenland is a must, presumably preceded by an elucidation of microbial sensitivity.

Topics: Amoxicillin; Anti-Bacterial Agents; Anti-Ulcer Agents; Dyspepsia; Esomeprazole; Greenland; Helicobacter Infections; Helicobacter pylori; Humans; Metronidazole