Healing Of Esophagitis Research Articles

Tu1113 Dexlansoprazole Modified-Release Orally-Disintegrating Tablet -The Bioavailability of Alternate Dosing Options

Introduction: The proton pump inhibitor dexlansoprazole (DEX) is a modified release (MR) formulation consisting of 2 types of granules within a single capsule. DEX delayed-release capsules are approved for use in adults for treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease, healing of erosive esophagitis (EE), and maintenance of healed EE and relief of heartburn. Because some patients are unable or unwilling to swallow capsules, a DEX MR orally-disintegrating (OD) tablet has been developed. DEX MR OD contains 2 types of granules that release drug in a pH-dependent manner in order to extend DEX plasma concentrations. Objective: To assess the bioavailability (BA) of DEX MR OD 30 mg tablet swallowed intact with water or mixed with water and administered via nasogastric (NG) tube or oral syringe compared to administration of DEX MR OD 30 mg on the tongue, allowed to disintegrate, and swallowed without water. Methods: This was a phase 1, randomized, single-dose, 4-period crossover study. Qualified healthy subjects 18-55 years old received a single oral dose of 30 mg DEX MR OD as an intact tablet administered on the tongue, swallowed intact, or mixed with water and administered via oral syringe or NG tube. Each study period was followed by a 5-day washout. Blood samples for determination of plasma pharmacokinetics were collected for 24 hours post-dose in each period. Analyses of variance models were performed, and bioequivalence (BE) between an administration option and DEX MR OD administered on the tongue without water was declared if 90% confidence intervals (CIs) of central value ratios between 2 regimens for maximum plasma concentration (Cmax) and area under the curve (AUC) mean ratios were contained within the BE limits of 0.80-1.25. Safety was assessed via physical examination (PE), clinical laboratory evaluation, vital sign assessment, electrocardiograms (ECG), and adverse event reports (AE). Results: Seventy-seven subjects (mean age 38±9.8 years) were enrolled. The 90% CIs for the BA of DEX MR OD 30 mg administered via oral syringe or NG tube, or swallowed intact, relative to that from administration of DEX MR OD on the tongue without water, for Cmax and AUCs were within the BE range of 0.80-1.25 (TABLE). All 4 regimens were well tolerated. AEs were mild in intensity and were considered not related to study drug. Percentages of subjects experiencing AEs were comparable across the 4 regimens. There were no clinically important findings noted in the PE, safety clinical laboratory, vital sign, or ECG reports. Conclusions: DEX MR OD 30 mg administered as an aqueous mixture via an oral syringe or an NG tube, or as an intact tablet swallowed with water was each BE to the administration of the DEX MR OD 30 mg on the tongue without water. Single oral doses of DEX MR OD tablets were well tolerated in this study. Table. BE Assessment of Administration Routes for DEX MR OD Tablets

Patient care services: What pharmacists do

Patient care services: What pharmacists do

APhA honors outstanding achievements at Annual Meeting

Each year, APhA recognizes exceptional contributors to the profession at the Annual Meeting. The following award winners will be honored at APhA2014 in Orlando.

Combination therapy of gamma-aminobutyric acid derivative promotes proton pump inhibitor based healing of reflux esophagitis in animal model

BackgroundThe present study was undertaken to elucidate the effect of omeprazole and baclofen on experimental esophagitis in albino rats. MethodsGroups of rats, fasted overnight received normal saline (3ml/kg, ip; sham control) or toxic control (3ml/kg, ip) or omeprazole (30mg/kg, ip) or baclofen (20mg/kg, ip) or their combinations, were subjected to the pylorus and forestomach ligation.Animals were sacrificed after 6h and evaluated for the gastric pH, volume of gastric juices, total acidity, esophagitis index and free acidity. Esophageal tissues were further subjected to estimations of TBARS, GSH, catalase and SOD. ResultsTreatment with omeprazole and baclofen significantly inhibited the gastric secretion, total acidity and esophagitis index. The treatment also helped to restore the altered level's oxidative stress parameters to normal. ConclusionThe beneficial effect of omeprazole and baclofen against GERD could be conglomerately attributed to the antisectretory action of omeprazole and reduction in the tracheal lower esophageal sphincter release rate by baclofen.

Comparative study of Omeprazole, Rabeprazole and Ilaprazole for their efficacy in patient suffering from reflux esophagitis with symptoms.

AIM- To evaluate whether there is any difference in efficacy between three proton pump inhibitors, Omeprazole, Rabeprazole and Ilaprazole in patients of reflux esophagitis with symptoms METHODS- The study was a prospective , randomized open label comparison, total one hundred and four patients with erosive reflux esophagitis in which 32 patients(group-A) received 20mg Omeprazole, 35 patients (group-B)received 20mg Rabeprazole, 37 patients (group-C) received 10mg Ilaprazole once a day in the morning. Daily change in heart burn and acid reflux symptoms in the first 7 days of administration were assessed using a four-point scale (0: none; 1: mild; 2: moderate; 3: severe). Rate of endoscopic healing of reflux esophagitis at week 8 were also assessed between three groups. RESULTS- All the groups were well matched in terms of age, sex, H pylori status, and the proportion of cases with heart burn and acid reflux symptoms before the administration of drugs. The mean heart burn scores in patients treated with Ilaprazole more rapidly decreased than those receiving Omeprazole or Rabeprazole. Complete resolution of heart burn was also more rapid in patient treated with Ilaprazole for 5 days compared with patients taking other proton pump inhibitors. Again acid reflux scores more rapidly decreased with Ilaprazole but no significant difference were seen between groups. Rate of endoscopic healing of reflux esophagitis was also more in Ilaprazole

Comparative study of pantoprazole and esomeprazole for erosive gastroesophageal reflux disease: a prospective study

Background: The objective of this study was to compare the efficacy of pantoprazole and esomeprazole to heal and relief from erosive esophagitis (EE) disease related symptoms. Methods: One hundred and ten patients (IIT-patients) with EE were randomized to receive 8 weeks of 40 mg pantoprazole (n=55) twice before food for first 7 days followed by once daily and esomeprazole 40 mg (n=55) once daily. Daily changes in heartburn and reflux were assessed. Results: The mean heartburn score with esomeprazole is more rapidly decreased than with pantoprazole. There no mild significant differences between two groups in the rate healing of reflux esophagitis at week and 4 and 8. The LA grade severity compare with esomeprazole group is rapidly decreased compared with pantoprazole. Esomeprazole 40 mg provided significantly greater healing than pantoprazole 40 mg after 4 weeks of treatment in patients with EE (56.36% vs. 49.09 %). Esomeprazole-treated patients were healed after up to 8 weeks of treatment similar those treated with pantoprazole (94.54% vs. 70.90 %). Conclusion: Esomeprazole is more effective than pantoprazole for rapid relief of heartburn symptoms and acid reflux symptoms in patients with reflux esophagitis.

Possible etiology of improvements in both quality of life and overlapping gastroesophageal reflux disease by proton pump inhibitor treatment in a prospective randomized controlled trial

BackgroundSymptoms suggestive of functional dyspepsia (FD) and irritable bowel syndrome (IBS) frequently overlap with those of gastroesophageal reflux disease. Despite the high prevalence of symptomatic overlap, the underlying etiology remains poorly defined. We assessed the correlation of symptomatic relief and health-related quality of life (HRQoL) with healing of reflux esophagitis to further derive insights into the underlying etiology.Methods626 patients with reflux esophagitis were enrolled into one of two treatment groups (classical healing concept or the complete remission concept) to investigate differences in treatment intensity. Patients were treated with pantoprazole until esophageal mucosal healing. Remission was followed for up to 6 months without treatment. Gastro-intestinal symptoms and HRQoL were analyzed using disease-specific, psychometrically validated patient-reported outcome instruments (ReQuest™, GERDyzer™).ResultsSymptomatic burden reflected by ReQuest™ substantially decreased from baseline to end of treatment by 83% and 88% in either treatment group, respectively. ReQuest™ scores significantly decreased in patients with or without heartburn and in those with symptoms suggestive of FD and IBS, indicating response of all symptom categories to treatment (p < 0.005). Therapy-associated relief of symptoms was paralleled by substantial gains in HRQoL, which continued to stabilize post-treatment.ConclusionsPantoprazole is effective in relieving upper and lower gastro-intestinal symptoms overlapping with erosive esophagitis, and provides sustained improvement in HRQoL post-treatment. Our results propose a link between both healing of erosive esophagitis and the slower remission of upper and lower gastro-intestinal symptoms. Since the improvement observed is likely to be multifactorial, the possibility for an immune-mediated etiology and identification of putative susceptibility factors by genome-wide association study may provide focus for future research.Trial registrationClinicalTrials.gov identifier: NCT00325676.

Stability of Dexlansoprazole MR Granules in Soft Foods and Liquids Appropriate for Alternative Methods of Administration

Purpose: The proton pump inhibitor dexlansoprazole (DEX) is a pH-dependent modified release (MR) formulation consisting of 2 types of granules within a single capsule. DEX MR is approved for use in adults for treatment of heartburn associated with symptomatic nonerosive gastroesophageal reflux disease (GERD), healing of erosive esophagitis (EE), maintenance of healed EE and relief of heartburn. The option to administer DEX MR granules mixed with liquids or soft foods is desirable for patients unable to take capsules. The objectives were to assess the in vitro stability of DEX MR granules when mixed with liquids or soft foods and assess the bioavailability (BA) of DEX MR granules mixed with applesauce or water. Methods: The stability of DEX MR granules in soft foods and liquids was determined by an in use stability study. DEX MR capsules were opened and granules were sprinkled on foods or mixed with liquids. After exposing the granules to foods or liquids under ambient conditions, the granules were analyzed for assay and dissolution to determine the DEX potency and the granule enteric coating integrity. Two phase 1, randomized, single-dose, crossover studies were conducted in healthy subjects 18-55 years old. In Study 1, subjects received a single oral dose of DEX MR 90 mg as a capsule or as granules sprinkled on applesauce. In Study 2, subjects received a single oral dose of DEX MR 60 mg as a capsule or an aqueous mixture of granules administered via oral syringe or NG tube. Blood samples for determination of DEX in plasma were collected for 24 hours post-dose. Analyses of variance models were performed, and bioequivalence (BE) between an administration option and the capsule was declared if 90% confidence intervals (CIs) of central value ratios between two regimens for maximum plasma concentration (Cmax) and area under the curve (AUC) were contained within the 0.80-1.25 BE limits. Results: Stability of DEX MR granules was established for at least 1 hour in liquids and soft foods ranging in pH from acidic to near neutral. DEX potency in the granules was not affected by exposing to the soft foods or liquids. The granule enteric coating integrity was well maintained. The 90% CIs for the relative BA of DEX MR 90 mg from granules sprinkled on applesauce to that of the capsule, and the 90% CIs for the relative BA of DEX MR 60 mg from an aqueous mixture of granules to that of the capsule for Cmax and AUCs were within the 0.80-1.25 BE range. Conclusion: Stability of DEX MR granules for 1 hour in liquids and soft foods was established. Administration of DEX MR granules mixed with applesauce or water was BE to the intact capsule. DEX MR granules in liquids or soft foods is expected to provide BA similar to the intact capsule. Disclosure - Michael Kukulka - Employee: Takeda Pharmaceuticals America, Inc. Haiyan Grady - Employee: Takeda Pharmaceuticals America, Inc. Richard Czerniak - Employee: Takeda Pharmaceuticals America, Inc. Jing-tau Wu - Employee: Takeda Pharmaceuticals America, Inc. Claudia Perez - Employee: Takeda Pharmaceuticals America, Inc.

In oesophageal squamous cells exposed to acidic bile salt medium, omeprazole inhibits IL-8 expression through effects on nuclear factor-κB and activator protein-1

ObjectiveOesophagitis might result from the effects of chemokines produced by oesophageal cells in response to gastro-oesophageal reflux, and not solely from the direct, caustic effects of refluxed gastric juice. Proton...

Gastro-oesophageal reflux. Part 3: medical and surgical treatment

Gastro-oesophageal reflux disease (GORD) is a recurrent, long-term gastrointestinal condition characterised by the abnormal reflux of stomach contents into the oesophagus. Heartburn is the most dominant symptom, which can be life long and can considerably reduce quality of life. The main goals of treatment are to alleviate symptoms and prevent relapses, oesophageal stricture and adenocarcinoma. This paper presents a review comparing the effectiveness of omeprazole with Nissen fundoplication surgery for the treatment of GORD. A search for English-language studies on adults was conducted using three databases-MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL). Thirteen studies were included in the review. Nissen fundoplication is more effective in controlling heartburn symptoms, healing oesophagitis and preventing relapses than omeprazole. Quality of life, in terms of productivity and ability to work, is difficult to assess in the omeprazole group and, as a result, a comparison of this aspect is limited. Although fundoplication is expensive in the short term, it is more cost-effective than omeprazole after 8 years. Nurses need to be aware of the effectiveness of omeprazole and fundoplication to provide patients with accurate information, which assists patients in decision making regarding treatment options.

Gastro-oesophageal reflux. Part 2: medical treatment

Gastro-oesophageal reflux disease (GORD) is a chronic disease characterised by retrograde movement of stomach contents into the oesophagus. It causes heartburn and oesophagitis and adversely affects quality of life. If left untreated it can lead to oesophageal stricture and carcinoma. The prevalence in Western countries is 30%. This paper presents a comparative review of the effectiveness of Omeprazole with Ranitidine for treatment of GORD. A search for English language studies on adults was conducted using three databases, MEDLINE, EMBASE and the Cochrane Central Register of RCTs. Thirty relevant studies were included in the review. Omeprazole is more effective in controlling heartburn symptoms, healing oesophagitis, improving quality of life and preventing relapses than Ranitidine, but takes time to reach therapeutic effect. Ranitidine is more effective at relieving symptoms on an as required basis. Nurses need to be aware of the effectiveness and use of these medications so that patients can make informed treatment choices and develop a greater understanding of the importance of concordance with prescriptions.

Current Pharmacological Management of Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD), a common disorder with troublesome symptoms caused by reflux of gastric contents into the esophagus, has adverse impact on quality of life. A variety of medications have been used in GERD treatment, and acid suppression therapy is the mainstay of treatment for GERD. Although proton pump inhibitor is the most potent acid suppressant and provides good efficacy in esophagitis healing and symptom relief, about one-third of patients with GERD still have persistent symptoms with poor response to standard dose PPI. Antacids, alginate, histamine type-2 receptor antagonists, and prokinetic agents are usually used as add-on therapy to PPI in clinical practice. Development of novel therapeutic agents has focused on the underlying mechanisms of GERD, such as transient lower esophageal sphincter relaxation, motility disorder, mucosal protection, and esophageal hypersensitivity. Newer formulations of PPI with faster and longer duration of action and potassium-competitive acid blocker, a newer acid suppressant, have also been investigated in clinical trials. In this review, we summarize the current and developing therapeutic agents for GERD treatment.

The role of Helicobacter pylori and CagA in response to treatment in Iranian Gastroesophageal Reflux Diseases patients.

This study was conducted to evaluate the influence H. pylori infection and anti-CagA status on the efficacy of Omeperazole 20 m.g. b.d. for patients with endoscopic oesophagitis. The influence of Helicobacter pylori (H. pylori) infection and its virulent strain (cytotoxin-associated gene A: CagA) has not been evaluated on efficacy of treatment for patients with erosive oesophagitis in Iran. One hundred and ten patients (55 H. Pylori positive and 55 H. Pylori negative) with endoscopic evidence of oeosphagitis were enrolled in this interventional study and treated with Omeprazole 20 m.g. b.d. Healing was assessed at repeat endoscopy after 8 weeks of treatment. H. Pylori infection and anti-CagA-IgG (immunoglobulin G) antibodies were determined for each subject by the rapid urease test, pathological assessment and ELISA. At repeat endoscopy, following 8 weeks of Omeprazole 20 m.g. b.d. therapy, endoscopic healing of oesophagitis had occurred in 32 % of the HP +ve patients and 23 % of the HP -ve patients (chi square p < 0.01). Among the HP +ve endoscopic healing occurred resolved in 11 (32.4 %) of the CagA +ve patients and 19 (90.5 %) of the CagA -ve patients. This difference was significant (chi-square p <0.001). H. pylori infection and the CagA virulence factor are associated with an increased rate of healing amongst patients with endoscopic oesophagitis treated with Omperazole 20 m.g. b.d. compared to patients without H. pylori infection.

Three-Year Results of a Multicenter Prospective Study of Transoral Incisionless Fundoplication

To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry. Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years. The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.

Efficacy of S-Pantoprazole 20 mg Compared with Pantoprazole 40 mg in the Treatment of Reflux Esophagitis: A Randomized, Double-Blind Comparative Trial

S-isomer (S) pantoprazole is known to be more effective and less dependent on cytochrome 2C19 than R-isomer (R)-pantoprazole. The purpose of this study was to compare the efficacy and safety of S-pantoprazole 20 mg versus pantoprazole 40 mg for treatment of reflux esophagitis. This multi-center, double-blind, randomized trial enrolled patients with endoscopically documented reflux esophagitis. Patients were assigned to receive either 20 mg S-pantoprazole or 40 mg pantoprazole once daily for 4 weeks. Endoscopy and symptoms were assessed after 4 weeks of treatment. In patients whose reflux esophagitis was not resolved at 4 weeks, treatment was extended to 8 weeks and symptoms were reassessed. Heartburn, chest pain, acid regurgitation, globus, and overall symptoms were rated. The primary efficacy endpoint was healing of esophagitis, and secondary endpoints were symptomatic and endoscopic improvement. Sixty-seven patients in the S-pantoprazole group (52 male, mean age 51 years) and 62 in the pantoprazole group (61 male, mean age 50 years) were analyzed per protocol. The healing rate of reflux esophagitis was 85 % at 4 weeks and 94 % at 8 weeks in the S-pantoprazole group, which did not differ from those in the pantoprazole group (84 and 97 %, respectively). After treatment, individual and overall gastroesophageal reflux disease (GERD) symptoms and esophagitis improved compared with baseline inflammation in both groups. Intergroup differences in symptoms and endoscopic healing were not significant. The efficacy and safety of 20 mg S-pantoprazole were comparable to those of 40 mg pantoprazole for treatment of reflux esophagitis and symptomatic improvement of GERD.

Quality of Life After Nissen-Rossetti Fundoplication

We investigated Quality of Life (QoL) and Johnsson & DeMeester score of patients after Nissen-Rossetti fundoplication. From January 2007 to June 2008, 43 patients with chronic gastroesophageal reflux underwent laparoscopic Nissen-Rossetti fundoplication; 7 were lost during the follow-up. Patients underwent endoscopy, 24-hour pH-metry, Gastroesophageal Reflux Disease-Health-Related Quality-of-Life (GERD-HRQL), and Short Form 36 (SF-36) questionnaires preoperatively, 6 months, and 12 months after surgery. Endoscopic findings revealed complete healing of esophagitis in all patients. Barrett esophagus was still present. Six patients reported persistence of symptoms but postoperative pH-metry and endoscopy showed the absence of reflux; 2 patients (5.5%) were still on proton pump inhibitor therapy at 12 months. Seven patients (19.4%) reported dysphagia for solids for at least 3 months. Readmission for dysphagia was required for 2 (5.5%) and 1 patient underwent endoscopic dilatation. At 6 and 12 months, no dysphagia was reported. During the follow-up, no gas-bloat syndrome was reported. The Johnsson & DeMeester score and QoL measurement obtained from GERD-HRQL and SF-36 revealed a significant improvement in the related domain. At 6 months, 23 patients (63.8%) were completely satisfied and after 12 months, 30 patients (83.3%) were satisfied. Nissen-Rossetti fundoplication is safe and effective for the treatment of GERD, improving QoL.

N-acetylcysteine for the prevention of stricture after circumferential endoscopic submucosal dissection of the esophagus: a randomized trial in a porcine model

BackgroundCircumferential endoscopic submucosal dissection (CESD) of the esophagus would allow for both the eradication of Barrett’s esophagus and its related complications, such as advanced neoplasia. However, such procedures generally induce inflammatory repair resulting in a fibrotic stricture. N-acetylcysteine (NAC) is an antioxidant that has shown some efficacy against pulmonary and hepatic fibrosis. The aim of our study was to evaluate the benefit of NAC in the prevention of esophageal cicatricial stricture after CESD in a swine model.Animals and methodsTwo groups of six pigs each were subjected to general anesthesia and CESD: after randomization, a first group received an oral NAC treatment regimen of 100 mg/kg/day, initiated one week before the procedure, whereas a second group was followed without any prophylactic treatment. Follow-up endoscopies took place seven, fourteen, twenty-one, and twenty-eight days after CESD. Necropsy, histological assessment of esophageal inflammation, and fibrosis were performed on day 28.ResultsThe median esophageal lumen diameter on day 21 (main judgment criterion) was 4 mm (range 2 to 5) in group 1 and 3 mm (range 1 to 7) in group 2 (P = 0.95). No significant difference was observed between the two groups regarding clinical evaluation (time before onset of clinically significant esophageal obstruction), number of dilations, esophageal inflammation and fibrosis, or oxidative stress damage on immunohistochemistry.ConclusionsDespite its antioxidant effect, systemic administration of NAC did not show significant benefit on esophageal fibrosis in our animal model of esophageal wound healing within the experimental conditions of this study. Since the administered doses were relatively high, it seems unlikely that NAC might be a valuable option for the prevention of post-endoscopic esophageal stricture.

Mo1069 Effect of Oral Administration of a New Proton Pump Inhibitor E3710 on 24-h Intra-Gastric pH in Japanese Subjects

Background and Aims: Due to recurring nature of GERD, Most patients require long term maintenance therapy and continuous medication of proton pump inhibitor (PPI) is an adequate option for patients with erosive esophagitis. The aim of this study was to evaluate the efficacy and cost minimization analysis of omeprazole 10 mg once daily and rabeprazole 10 mg once daily for 24 weeks in the maintenance of remission Methods:This is randomized, open-label study enrolled 279 patients with erosive esophagitis A or B (LA classification) and typical GERD symptoms. Patients who showed complete endoscopic and symptomatic healing after 8 weeks PPI treatment were randomly allocated to maintenance treatment with omeprazole 10mg once daily or rabeprazole 10mg once daily for 42 weeks. The primary efficacy endpoint was the proportion of patients with symptomatic remission at 42 weeks. Secondary assessments included healing of reflux esophagitis, severity and frequency of reflux symptoms and cost-minimization analysis in the maintenance phase Results:At the end of 42 weeks of maintenance therapy, 96.4% of omeprazole treated and 95.1% of rabeprazole treated patients remained symptom free (P>0.05). Omeprazole and rabeprazole were also similarly efficacious in terms of endoscopic non-relapse rate for RE with 93.3% of patients on omeprazole and 97.5% of patients of rabeprazle. (P>0.05) Two drugs were also comparable with regard to severity and frequency of reflux symptoms duringmaintenance phase. (P>0.05) In the cost-minimization analysis, The mean total costs per patient for remaining symptom free within 6 months was 241,775 won in omeprazole and 287,115 won in rabeprazole, respectively.(as if 24 November 2011, 1 USD= 1,176.33 won) Conclusions:Omeprazole 10mg appeared to have a similar efficacy in maintaining symptomatic remission as rabeprazole 10 mg, but had a lower total cost per patient than rabeprazole 10mg.

Mo1066 A Multi-Center, Randomized, Double Blinded, Phase 4 Clinical Trial to Assess the Efficacy and Cost Effectiveness of Omeprazole Compare to Rabeprazole in the Maintenance Therapy of Patients With Gastroesophageal Reflux Disease

Background and Aims: Due to recurring nature of GERD, Most patients require long term maintenance therapy and continuous medication of proton pump inhibitor (PPI) is an adequate option for patients with erosive esophagitis. The aim of this study was to evaluate the efficacy and cost minimization analysis of omeprazole 10 mg once daily and rabeprazole 10 mg once daily for 24 weeks in the maintenance of remission Methods:This is randomized, open-label study enrolled 279 patients with erosive esophagitis A or B (LA classification) and typical GERD symptoms. Patients who showed complete endoscopic and symptomatic healing after 8 weeks PPI treatment were randomly allocated to maintenance treatment with omeprazole 10mg once daily or rabeprazole 10mg once daily for 42 weeks. The primary efficacy endpoint was the proportion of patients with symptomatic remission at 42 weeks. Secondary assessments included healing of reflux esophagitis, severity and frequency of reflux symptoms and cost-minimization analysis in the maintenance phase Results:At the end of 42 weeks of maintenance therapy, 96.4% of omeprazole treated and 95.1% of rabeprazole treated patients remained symptom free (P>0.05). Omeprazole and rabeprazole were also similarly efficacious in terms of endoscopic non-relapse rate for RE with 93.3% of patients on omeprazole and 97.5% of patients of rabeprazle. (P>0.05) Two drugs were also comparable with regard to severity and frequency of reflux symptoms duringmaintenance phase. (P>0.05) In the cost-minimization analysis, The mean total costs per patient for remaining symptom free within 6 months was 241,775 won in omeprazole and 287,115 won in rabeprazole, respectively.(as if 24 November 2011, 1 USD= 1,176.33 won) Conclusions:Omeprazole 10mg appeared to have a similar efficacy in maintaining symptomatic remission as rabeprazole 10 mg, but had a lower total cost per patient than rabeprazole 10mg.

Tu1593 Alginate Accelerates Healing of Post-Endoscopic Variceal Ligation Ulcers: a Randomized-Controlled Trial

Endoscopic variceal ligation (EVL) is a standard treatment for esophageal varices (EV). However, post-EVL ulcers may cause complications such as chest pain, dysphagia and more seriously, bleeding ulcer. Since gastric reflux can interfere esophageal ulcer healing, prevention of gastric reflux with alginate may be able to accelerate the ulcer healing and reduce ulcer complication. This study aimed to evaluate the effect of oral alginate on the healing of post-EVL ulcers and frequency of ulcer complications.