Rabeprazole for the prevention of recurrent erosive or ulcerative gastro-oesophageal reflux disease. Rabeprazole Study Group

OBJECTIVES: To evaluate the efficacy and tolerability of rabeprazole 10 mg and 20 mg versus placebo for the prevention of endoscopically demonstrable relapse in patients previously diagnosed with erosive or ulcerative gastro-oesophageal reflux disease (GORD) who had no oesophageal erosions or ulcerations at study entry. The study also assessed the effectiveness of rabeprazole in preventing GORD symptom recurrence and reductions in quality of life. DESIGN/METHODS: The trial used a multicentre, randomized, double-blind, parallel-group design and enrolled 288 male and female outpatients of > or =18 years of age. Patients were assigned to treatment with either rabeprazole 10 mg or 20 mg once daily in the morning (QAM) or placebo and followed for 52 weeks. RESULTS: Both rabeprazole doses were significantly more effective than placebo in preventing endoscopically demonstrable GORD relapse (P<0.001 versus placebo). The cumulative relapse rate for rabeprazole 10 mg at week 52 was 23%; for rabeprazole 20 mg, 14%; and for placebo, 71%. Both rabeprazole doses were also significantly superior to placebo in preventing relapse of heartburn frequency (P<0.001 for all comparisons between rabeprazole and placebo), with no significant differences between the two doses. Rabeprazole was also significantly more effective than placebo in preventing relapse of day-and night-time heartburn severity, maintaining overall patient well-being, and reducing antacid use. Both rabeprazole doses were well tolerated; most treatment-emergent adverse events were mild or moderate. There were no clinically significant changes in clinical laboratory values, thyroid function tests, vital signs, or electrocardiograms. CONCLUSION: Once-daily treatment with rabeprazole 10 mg or 20 mg is effective and well tolerated in preventing relapse of erosive or ulcerative GORD and associated symptoms and maintaining quality of life.     

Rabeprazole Versus Omeprazole in Preventing Relapse of Erosive or Ulcerative Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a chronic condition, with 50–80% of patients experiencing recurrence within one year of completing initial treatment. In patients with erosive GERD, proton-pump inhibitors (PPI) provide faster healing and symptom relief than do H₂-receptor antagonists and have become the treatment of choice. Rabeprazole is a new PPI with demonstrated efficacy in both the acute and maintenance treatment of erosive GERD. The primary objective was to compare efficacy and tolerability of rabeprazole and omeprazole in preventing relapse of healed erosive GERD. Secondary objectives included comparison of efficacy in preventing GERD relapse symptoms and in maintaining quality of life. In this multicenter, double-blind, parallel-group study, 243 patients with healed erosive GERD were randomised to receive rabeprazole 10 mg once daily in the morning (QAM) (N = 82); rabeprazole 20 mg QAM (N = 78); or omeprazole 20 mg QAM (N = 83). Endoscopies were performed at weeks 13, 26, 39 (if clinically indicated), and 52, or when symptoms suggested recurrence. Corpus biopsies were performed at each endoscopy, and antral biopsies were performed at study entry and exit. Rabeprazole 10 mg and 20 mg QAM were equivalent to omeprazole 20 mg QAM for all efficacy parameters. At week 52, relapse rates in the intent-to-treat populations were 5%, 4%, and 5% for rabeprazole 10 mg and 20 mg and omeprazole 20 mg, respectively. All treatments were well tolerated. In conclusion, both rabeprazole 10 mg and 20 mg QAM are equivalent to omeprazole 20 mg QAM in preventing recurrence of erosive GERD.     

Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis

BACKGROUND: Up to three quarters of patients with gastroesophageal reflux disease (GERD) have symptoms, such as heartburn, but no macroscopic evidence of erosive esophagitis, making symptomatic GERD a common clinical problem in the primary care setting. OBJECTIVE: To compare the efficacy and safety of omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; and placebo in the treatment of symptomatic GERD without erosive esophagitis. METHODS: Patients with a history of heartburn (> or =12 months) and episodes of moderate to severe heartburn on 4 or more of the 7 days before endoscopy were eligible to participate in this 4-week, randomized, double-blind, placebo-controlled trial. The absence of erosive esophagitis was established through endoscopy. Eligible patients were randomized to 1 of 3 treatment groups: omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; or placebo. Patients were assessed at weeks 2 and 4. The efficacy of omeprazole for the treatment of heartburn was determined mainly through the following diary card data: daily resolution of heartburn and complete resolution of heartburn every day during 1 week of treatment. The efficacy of omeprazole for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea was also assessed. RESULTS: Of 359 randomized patients, 355 were included in the statistical analysis (intention-to-treat population). Daily proportions of patients with no heartburn were consistently greater in the 20-mg omeprazole group (62%, day 7; 74%, day 27) than in the 10-mg omeprazole group (41%, day 7; 49%, day 27) or the placebo group (14%, day 7; 23%; day 27). Complete resolution of heartburn every day during the last treatment week was significantly (P< or =.002) higher in the 20-mg omeprazole group (48%) than in the 10-mg omeprazole (27%) or placebo (5%) group. Omeprazole was significantly (P< or =.003) more effective than placebo for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea. CONCLUSIONS: Patients with symptomatic GERD require profound acid suppression to achieve symptomatic relief. Omeprazole, 20 mg once daily, was superior to omeprazole, 10 mg once daily, and to placebo in providing early and sustained resolution of heartburn, as well as treatment of other troublesome GERD symptoms.     

Omeprazole 10 mg or 20 mg once daily in the prevention of recurrence of reflux oesophagitis. Solo Investigator Group.

This study determined the optimal maintenance dose of omeprazole in reflux oesophagitis. One hundred and ninety three patients rendered asymptomatic and healed after four or eight weeks omeprazole were randomised double blind to 10 mg omeprazole once daily (n = 60 evaluable), 20 mg omeprazole once daily (n = 68), or placebo (n = 62) for one year or until symptomatic relapse. Each omeprazole regimen was superior to placebo in preventing both symptomatic relapse (life table analysis, p < 0.001) and endoscopically verified relapse (p < 0.001). At 12 months, the life table endoscopic remission rates (proportions of patients without grade > or = 2 oesophagitis) were: 50% (95% confidence intervals 34 to 66%) with 10 mg omeprazole once daily, 74% (62 to 86%) with 20 mg omeprazole once daily, and 14% (2 to 26%) with placebo. At 12 months, the life table symptomatic remission rates (proportions of patients asymptomatic or with mild symptoms) were: 77% (64 to 89%) with 10 mg omeprazole once daily, 83% (73 to 93%) with 20 mg omeprazole once daily, and 34% (16 to 52%) with placebo. Both 10 mg and 20 mg omeprazole once daily were effective in prolonging the remission of reflux oesophagitis: 10 mg may be appropriate to start longterm treatment, though the existence of a dose response relation means that 20 mg once daily may be effective in patients for whom 10 mg once daily is suboptimal.     

Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial

OBJECTIVES: Clinical results to date suggest that antisecretory therapy may be less effective in providing symptom relief for patients with nonerosive gastroesophageal reflux disease (GERD) than for patients with erosive disease. This study was carried out to assess the efficacy and rapidity of once-daily rabeprazole (10 mg or 20 mg) in relieving symptoms in endoscopically negative patients with moderately severe GERD symptoms and to evaluate the safety of these doses over 4 wk. METHODS: This placebo-controlled, double blind study enrolled 203 men and women with moderately severe symptoms of GERD. After a 2-wk, single-blind placebo run-in phase, patients were randomized to receive 10 mg or 20 mg of rabeprazole or placebo once daily for 4 wk. RESULTS: Rabeprazole rapidly and effectively relieved heartburn, with significant improvements on day 1 of dosing. It also improved most other GERD-related symptoms, including regurgitation, belching, bloating, early satiety, and nausea. Both rabeprazole doses were significantly superior to the placebo with respect to time to the first 24-h heartburn-free interval (2.5 and 4.5 days for 10 mg and 20 mg of rabeprazole, respectively, vs 21.5 days for the placebo) and first daytime or nighttime heartburn-free interval (1.5-3 days for rabeprazole groups vs 12.5-15 days for the placebo), as well as to percentage of time patients were heartburn-free and free of antacid use. Both rabeprazole doses were well tolerated. CONCLUSIONS: Based on these findings and prior studies, rabeprazole reliably relieves GI symptoms equally well in both nonerosive GERD and erosive GERD.     

A randomized, prospective, comparative, multicenter study of rabeprazole and ranitidine in the treatment of reflux esophagitis]

BACKGROUND/AIMS: This study was done to evaluate the efficacy of rabeprazole (proton-pump-inhibitor) and ranitidine (H(2)-receptor antagonist) in the symptom relief and treatment of erosive esophagitis diagnosed by endoscopy. METHODS: A total of 110 patients with typical gastroesophageal reflux disease (GERD) symptoms were enrolled in this multicenter study. They were randomized into rabeprazole group (53 patients) and ranitidine group (57 patients) respectively. The patients in rabeprazole group were given 10 mg of rabeprazole and ranitidine group received 300 mg of ranitidine before breakfast and dinner for 8 weeks. After the end of treatment, we evaluated the endoscopic healing rate of reflux esophagitis and symptomatic improvement. RESULTS: After 8 weeks of treatment, rabeprazole group showed significantly higher complete endoscopic cure rate than ranitidine group (86.8% [46/53] vs. 57.9% [33/57], p=0.001) and higher symptomatic improvement of heartburn (91.2% [31/34] vs. 76.2% [32/42], p=0.085), especially in the first 7 days (76.7% vs. 45.3%, p=0.008). Also, rabeprazole group showed significantly higher improvement of regurgitation symptom than ranitidine group (100% [35/35] vs. 83% [39/47], p=0.009). Both group showed no differences in the improvement of chest pain and globus sensation. All the adverse events (rabeprazole group 4 events vs. ranitidine group 3 events) were mild and there was no abnormality in laboratory test. CONCLUSIONS: In patients with GERD, rabeprazole 10 mg b.i.d. is superior to ranitidine 300 mg b.i.d. in healing of reflux esophagitis and resolving typical GERD symptoms. Rabeprazole is an effective and well-tolerated drug for GERD treatment.     

Cisapride for Gastroesophageal Reflux Disease: A Placebo-Controlled, Double-Blind Study

Objectives : To evaluate the safety and efficacy of cisapride in patients with gastroesophageal reflux disease. Methods : Patients (N = 177) were randomized to double-blind treatment with cisapride (10 or 20 mg q.i.d .) or placebo for 12 wk. Efficacy was determined by pre- and poststudy endoscopies, symptom assessments by patient and physician, and Maalox consumption. Safety evaluations included vital signs, electrocardiograms, clinical laboratory tests, and reports of adverse events. Results : Cisapride 10 ing significantly reduced daytime and nighttime heartburn at 4 wk compared with placebo. Cisapride 20 mg reduced both daytime and nighttime heartburn at 4, 8, and 12 wk, compared with placebo, and was also significantly superior to the 10-mg dose at 12 wk. The percent of patients with endoscopic healing was significantly higher with cisapride 20 mg than with placebo [healing: 51 vs 36% ( p ≤ 0.044)1. Maalox usage declined significantly with cisapride 20 mg compared with placebo. No clinically significant changes in safety variables occurred with cisapride. The most frequently reported adverse events in the cisapride group were diarrhea, headache, and sinusitis. Conclusions : Cisapride 10 and 20 mg q.i.d . were safe and well tolerated in a population of patients with mild-to-moderate gastro-esophageal reflux disease. Both symptoms and endoscopic grade improved after 12 wk of treatment with cisapride 20 mg q.i.d .     

Randomized, double-blind, comparative study of dexrabeprazole 10 mg versus rabeprazole 20 mg in the treatment of gastroesophageal reflux disease

AIM：TO compare the efficacy and safety of dexrabe-prazole 10 mg versus rabeprazole 20 mg in the treatment of gastroesophageal reflux disease （GERD）.
METHODS： This was a randomized, double-blind clinical study. Fifty patients with GERD were randomly assigned to receive dexrabeprazole 10 mg or rabeprazole 20 mg once daily. Efficacy was assessed by evaluating improvement in visual analog scale （VAS） scores of heart-burn and regurgitation and safety was assessed by recording incidence of any adverse drug reactions. Laboratory investigations and upper gastro-intestinal endoscopy was conducted at baseline and after 28 d of therapy.
RESULTS： A total of 50 patients （n = 25 in dexrabeprazole group and rabeprazole group each） completed the study. There were no significant differences in the baseline characteristics between the two groups. The VAS score （mean 4. SD） of heartburn and regurgitation in dexrabeprazole （64.8±5.1 and 64 ± 8.1, respectively） and rabeprazole （64.4 ± 8.7 and 57.6 ± 9.7, respectively） groups significantly reduced （P 〈 0.0001） to 30 ± 11.5, 24 ± 10 and 32 ± 9.5, 29.2±11.9, respectively on d 28. A significantly higher （P = 0.002） proportion of patients showed ≥ 50% improvement in regurgitation with dexrabeprazole 10 mg （96%） compared to rabeprazole 20 mg （60%）. Onset of symptom improvement was significantly earlier with dexrabeprazole than with rabeprazole （1.8 ± 0.8 d vs 2.6 ± 1.4 d; P 〈0.05）. The incidences of esophagitis in the dexrabeprazole group and rabeprazole group before therapy were 84% and 92%, respectively （P = 0.38）. The incidence of improvement/healing of esophagitis after therapy was more （P = 0,036） in the dexrabeprazole group （95.2%） compared to the rabeprazole group （65.2%）. No adverse drug reaction was seen in either group.
CONCLUSION： In the treatment of GERD, efficacy of dexrabeprazole 10 mg is better than rabeprazole 20 mg, with regards to improvement/healing of endoscopic lesions and relief fro     

Rabeprazole in Treatment of Acid Peptic Diseases (Results of Three Placebo-Controlled Dose-Response Clinical Trials in Duodenal Ulcer, Gastric Ulcer, and Gastroesophageal Reflux Disease (GERD))

Rabeprazole, a new proton pump inhibitor, wasstudied in patients with acid-pepticrelated diseases(duodenal ulcer, gastric ulcer, GERD) in threeplacebo-controlled, double-blind, randomized clinicaltrials. Men and women over the age of 18 were enrolledif the presence of an active duodenal or gastric ulceror erosive or ulcerative esophagitis was confirmed onupper gastrointestinal endoscopy. Patients were randomly allocated to either placebo orrabeprazole 20 mg or 40 mg in the duodenal and gastriculcer protocols or to placebo or rabeprazole 10 mg, 20mg, or 40 mg in the GERD protocol. All doses ofrabeprazole in all three studies were statisticallysignificantly superior to placebo in healingacid-related lesions. There were no treatmentdifferences between the rabeprazole doses in healingactive peptic lesions. The incidence of positive [¹³C]ureabreath test for H. pylori was 53% in patients withduodenal or gastric ulcers. H. pylori status was noteffected by treatment with rabeprazole.     

Efficacy and safety of sustained-release propafenone (propafenone SR) for patients with atrial fibrillation

The objective of this randomized, double-blind, placebo-controlled clinical trial was to test the efficacy and safety of a new sustained-release preparation of the antiarrhythmic drug propafenone (propafenone SR) in reducing the frequency of symptomatic arrhythmia recurrences in patients with atrial fibrillation (AF). Patients with a history of symptomatic AF who were in sinus rhythm were randomly assigned to receive placebo or propafenone SR 425, 325, or 225 mg, all twice daily. Recurrent symptomatic arrhythmias were documented using transtelephone electrocardiographic monitoring. Electrocardiograms were reviewed by an event committee that was blinded to treatment assignment. In the primary efficacy analysis, propafenone SR significantly lengthened the time to first symptomatic atrial arrhythmia recurrence at all 3 doses compared with placebo as assessed by log-rank test: propafenone SR 425 mg twice daily versus placebo twice daily, p <0.001; 325 mg twice daily versus placebo twice daily, p <0.001; and 225 mg twice daily versus placebo twice daily, p = 0.014. The median time to recurrence was 41 days in the placebo twice daily group, >300 days in the propafenone SR 425-mg group, 291 days in the 325-mg group, and 112 days in the 225-mg group. Adverse effects leading to withdrawal were higher in the propafenone SR 425-mg twice daily group than in any other group. Thus, propafenone SR has important and statistically significant antiarrhythmic effects in patients with AF.     

Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease: A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole

BACKGROUND: Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones. AIM: To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis. METHODS: Patients (n=560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2x10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks. RESULTS: After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9%) patients in the rabeprazole group and in 231/237 (97.5%) in the omeprazole one (equivalence effect demonstrated by p<0.0001 at Blackwelder test and an upper confidence limit at 97.5% of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8+/-0.2 versus 4.7+/-0.5 days of therapy to reach the first day with satisfactory heartburn relief, p=0.0045 at log-rank test). In the maintenance phase, 15.2% of patients had an endoscopic and/or clinical relapse. CONCLUSION: Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.     

Maintenance therapy for erosive esophagitis in children after healing by omeprazole: is it advisable?

OBJECTIVES: To evaluate the efficacy of acid-suppressive maintenance therapy for gastroesophageal reflux disease (GERD) in children, after the healing of reflux esophagitis. METHODS: Forty-eight children (median age 105 months, range 32-170) with erosive reflux esophagitis were initially treated with omeprazole 1.4 mg/kg/day for 3 months. Patients in endoscopic remission were assigned in a randomized, blinded manner by means of a computer-generated list to three groups of 6-month maintenance treatment: group A (omeprazole at half the starting dose, once daily before breakfast), group B (ranitidine 10 mg/kg/day, divided in two doses), and group C (no treatment). Endoscopic, histological, and symptomatic scores were evaluated at: T0, enrollment; T1, assessment for remission at 3 months after enrollment (healing phase); T2, assessment for effective maintenance at 12 months after T0 (3 months after the completion of the maintenance phase). Relapse was defined as the recurrence of macroscopic esophageal lesions. After the completion of the maintenance phase, patients without macroscopic esophagitis relapse were followed up for GERD symptoms for a further period of 30 months. RESULTS: Of 48 initially treated patients, 46 (94%) healed and entered the maintenance study. For all patients, in comparison to T0, the histological, endoscopic, and symptomatic scores were significantly reduced both at T1 and T2 (P<0.0001, for each). No significant difference was found in these three scores, comparing group A, B, and C at T1 and T2. A relapse occurred in one patient only, who presented with macroscopic esophageal lesions at T2. Three months after the completion of the maintenance phase, 12 (26%) patients complained of symptoms sufficiently mild to discontinue GERD therapy, excluding the patient who showed macroscopic esophagitis relapse. Three of 44 (6.8%) patients reported very mild GERD symptoms within a period of 30 months after maintenance discontinuation. CONCLUSIONS: Our pediatric population showed a low rate of erosive esophagitis relapse and GERD symptom recurrence long term after healing with omeprazole, irrespective of the maintenance therapy.     

Rabeprazole vsesomeprazole in non-erosive gastro-esophagea reflux disease： A randomized, double-blind study in urban Asia

AIM: Gastro-esophageal reflux disease (GERD) is becoming increasingly common in Asia. Data on the efficacy of proton pump inhibitors in patients with non-erosive GERD (NERD) in Asia is lacking. This double-blind study compared the efficacy and safety of rabeprazole with esomeprazole in relief of symptoms in patients with NERD. METHODS: One hundred and thirty-four patients with reflux symptoms of NERD and normal endoscopy were randomized to receive rabeprazole 10 mg or esomeprazole 20 mg once daily for 4 wk. Symptoms were recorded in a diary and changes in severity of symptoms noted. RESULTS: At 4 wk of treatment, rabeprazole 10 mg and esomeprazole 20 mg were comparable with regards to the primary endpoint of time to achieve 24-h symptom-free interval for heartburn 8.5 d vs 9 d and regurgitation 6 d vs 7.5 d. Rabeprazole and esomeprazole were also similarly efficacious in term of patient's global evaluation with 96% of patients on rabeprazole and 87.9% of patients on esomeprazole, reporting that symptoms improved (P= NS). Satisfactory relief of day- and night-time symptoms was achieved in 98% of patients receiving rabeprazole and 81.4% of patients receiving esomeprazole. Adverse events were comparable in both groups (P = NS). CONCLUSION: Rabeprazole 10 mg has a similar efficacy and safety profile in Asians with NERD as esomeprazole 20 mg. Further study is necessary to investigate whether the small differences between the two drugs seen in this study are related to the improved pharmacodynamic properties of rabeprazole. Both drugs were well tolerated.     

Oral pantoprazole for erosive esophagitis: a placebo-controlled, randomized clinical trial. Pantoprazole US GERD Study Group

OBJECTIVES: The aim of this dose-response study was to compare the effectiveness of 10 mg, 20 mg, and 40 mg of pantoprazole with that of placebo tablets in the healing and symptom relief of gastroesophageal reflux disease associated with erosive esophagitis, and to determine the optimal dose. METHODS: A total of 603 patients with endoscopically confirmed (Hetzel-Dent scale) erosive esophagitis of grade 2 (64.5%) or grades 3 or 4 (35.3%) were enrolled in a double-blind, multicenter study and randomly assigned to receive pantoprazole (10 mg, 20 mg, or 40 mg) or placebo, administered once daily in the morning, for 4 or 8 wk depending on healing. RESULTS: The healing rates after 4 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 14%, 42%, 55%, and 72%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). Cumulative healing rates after 8 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 33%, 59%, 78%, and 88%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). The 40-mg pantoprazole dose produced greater rates of healing and earlier healing of esophagitis than either the 10- or 20-mg dose, regardless of severity. Pantoprazole, at any dose, was significantly more effective than placebo in relieving reflux symptoms. Patients on pantoprazole 40 mg experienced relief of symptoms on day 1 of treatment. No serious treatment-related adverse events occurred. CONCLUSIONS: Pantoprazole was safe and effective for healing erosive esophagitis and provided rapid symptomatic relief. These results indicate that pantoprazole offers a new option for treatment of erosive esophagitis. Among the three doses studied, the 40-mg dose was the most effective.     

A randomized, comparative study of rabeprazole vs. ranitidine maintenance therapies for reflux esophagitis--multicenter study]

BACKGROUND/AIMS: Reflux esophagitis is a recurring condition for which many patients require maintenance therapy. This comparative, randomized multicenter study was designed to evaluate the effect of long-term maintenance treatment comparing proton pump inhibitor, rabeprazole and H2 receptor antagonist, ranitidine. METHODS: Eighty four patients with healed reflux esophagitis confirmed by endoscopy were randomly allocated to receive maintenance treatment with either rabeprazole 10 mg once daily or ranitidine 300 mg once daily for 32 weeks. Patients were seen every 8 weeks or at symptomatic relapse. RESULTS: Of 84 initially treated patients, 73 entered the maintenance study. The percentage of asymptomatic patients after 90-day and 210-day treatment were 97% and 81.5%, for rabeprazole and 74.3% and 62.3%, for ranitidine, respectively. After 32 weeks, the relapse rates of esophagitis were 21.3% in the rabeprazole group and 62.9% in the ranitidine group (RR: 0.405, 95% CI: 0.215-0.766). CONCLUSIONS: Maintenance treatment with rabeprazole (10 mg once daily) is superior to ranitidine (300 mg once daily) in keeping the patients with reflux esophagitis in remission over a 32 week period.     

Pantoprazole 20 mg is an effective maintenance therapy for patients with gastro-oesophageal reflux disease

OBJECTIVES: To compare the efficacy of 20 mg with 40 mg pantoprazole in maintaining symptomatic and endoscopic remission in patients with gastro-oesophageal reflux disease (GORD). STUDY DESIGN: Patients (18-84 years old; n = 433) with healed GORD II or III were included in this prospective multi-centre, randomized, parallel, double-blind study. Pantoprazole was administered once daily for up to 1 year as either a 20 mg or 40 mg enteric-coated tablet to 221 and 212 patients, respectively. Symptoms of GORD were assessed every 3 months. Endoscopy was performed at entry, after 6 and 12 months, or when symptoms of GORD were perceived on at least three consecutive days. The primary efficacy parameter was the time until endoscopically proven relapse of GORD occurred (stage I or greater); the secondary parameters included tolerability, safety, and time until symptomatic relapse occurred. RESULTS: In the 20 mg treatment group, 87% and 75% of patients were in endoscopic remission after 6 and 12 months, respectively; the corresponding rates in the 40 mg treatment group were 91% and 78%. In both treatment groups, GORD stage I accounted for about 50% of endoscopic relapses. The symptomatic remission rates in the 20 mg group were estimated as 85% and 77% after 6 and 12 months, respectively; the corresponding values in the 40 mg group were 87% and 76%. No correlation was seen either between the endoscopically proven relapse and perception of symptoms, or between the severity of the pre-treatment stage of GORD and the maintenance dose of pantoprazole. Both doses were well tolerated. CONCLUSIONS: Both the 20 mg and 40 mg doses of pantoprazole are safe and effective in maintaining patients with healed reflux oesophagitis in remission. Moreover, for the majority of patients, the 20 mg dose provides adequate long-term therapeutic efficacy at a minimal drug exposure and lower costs.     

On-demand therapy with pantoprazole 20 mg as effective long-term management of reflux disease in patients with mild GERD: the ORION trial

AIMS: To compare safety and efficacy of on-demand pantoprazole 20 mg/40 mg versus placebo in the long-term management of patients with mild gastroesophageal reflux disease (GERD) after heartburn relief. METHODS: A total of 634 patients with endoscopically confirmed GERD grade 0/I and heartburn were included. During the acute phase, patients were treated with pantoprazole 20 mg once daily for 4 weeks. Those patients relieved from heartburn entered the long-term phase, and were randomly assigned to either treatment group pantoprazole 20 mg, 40 mg or placebo. Over 6 months, patients took study medication on demand (antacids as rescue medication) and discontinued the drug once symptoms abated. RESULTS: After 4 weeks a total of 87.1%/90.0% of patients were free of heartburn (ITT/PP), and entered the subsequent long-term phase. The perceived average daily symptom load (placebo: 3.93, pantoprazole 20 mg: 2.91, pantoprazole 40 mg: 2.71, ITT) and the number of antacid tablets taken (average number, placebo: 0.68, pantoprazole 20 mg: 0.45, pantoprazole 40 mg: 0.33, ITT) were significantly higher in the placebo than in both pantoprazole groups (p<0.0001), with no statistically significant difference between the two pantoprazole groups. The discontinuation rate due to insufficient control of heartburn was significantly lower in both pantoprazole groups compared to placebo (placebo: 10.9, pantoprazole 20 mg: 2.8, pantoprazole 40 mg: 0.9, ITT). CONCLUSIONS: Our findings favor on-demand treatment with pantoprazole 20 mg for the long-term management of heartburn in patients with uncomplicated GERD (grade 0/I) with superiority to placebo.     

膈肌生物反馈训练治疗胃食管反流病40例临床研究

目的探讨膈肌生物反馈训练加强GERD患者胃食管交界处（EGJ）抗反流屏障作用。方法80例GERD患者随机分为PPI组和PPI联合膈肌生物反馈训练组。每组分别人选40例,疗程为8周。PPI组（雷贝拉唑10mgBid）。反馈＋PPI组在应用PPI治疗同时进行膈肌生物反馈训练（2次／d,15-20min／次,雷贝拉唑10mgBid）。反馈＋PPI组患者每周1次到医院在医生指导下进行反馈训练,训练时需空腹。疗程结束后再次评价反流症状、食管动力和内镜下反流性食管炎改善情况。结果（1）治疗8周后,反馈＋PPI组反流症状积分由治疗前（10．5±5．3）下降至（6．0±3．7）,PPI组由治疗前（10．8±4．7）下降至（7．5±3．2）;（2）反馈＋PPI组生活质量（GERD—HRQL）积分由治疗前（21．774-6．30）下降至（13．60±7．538）,PPl组由治疗前（20．42±6．31）下降至（13．864±7．538）;（3）反馈＋PPI组较PPI组自主神经受累改善率提高35％;（4）反馈＋PPI组与PPI组治疗前后Zung氏焦虑和抑郁自评量表评分比较差异无统计学意义（P〉O．05）;（5）动力学复查,除膈脚张力显著增加外,LES压力、EGJ压力及食管远端蠕动收缩波幅训练前后差异均无统计学意义。结论膈肌生物反馈训练能显著改善反流症状,减少GERD患者对抑酸药物依赖性;增加GERD患者膈脚的张力,从而增强胃食管交界处的抗反流屏障作用。     

Two and four weeks' treatment for duodenal ulcer. Symptom relief and clinical remission comparing omeprazole and ranitidine. Scandinavian Clinics for United Research

In a Swedish-Norwegian multicentre study patients with endoscopically verified duodenal ulcers (greater than 5 mm) were randomized to 2 or 4 weeks of treatment with either 20 mg omeprazole once daily or 300 mg ranitidine once daily. The aim was to evaluate 2 and 4 weeks' treatment with regard to symptomatic improvement during treatment, relapse after treatment, and safety of the two drugs. Endoscopy was not performed to check healing at the end of treatment. Instead the patients were instructed to contact the investigator in the event of recurrence of symptoms for renewed endoscopy. Follow-up was ended 10 weeks after stopping active treatment. Altogether 450 patients were evaluated at 17 centres. The symptomatic improvement during treatment was good in all groups, with significantly better reductions of daytime pain and heartburn in omeprazole-treated patients. Symptomatic relapse was commonest in the 2-week ranitidine group (57%), significantly more than in the 2-week omeprazole group (31%) (p less than 0.003). In the 4-week groups relapse rates were 34% (ranitidine) and 39% (omeprazole) (NS). It is suggested that in the short-term treatment of acute duodenal ulcer 20 mg omeprazole once daily is most rationally used in a 2- to 4-week regimen, whereas 300 mg ranitidine once daily should not be used for less than 4 weeks.     

Rabeprazole, 20 mg once daily or 10 mg twice daily, is equivalent to omeprazole, 20 mg once daily, in the healing of erosive gastrooesophageal reflux disease

BACKGROUND: Proton pump inhibitors are the most potent pharmacologic inhibitors of gastric acid secretion currently available, and have proven effective in the treatment of gastro-oesophageal reflux disease (GERD). The object of this study was to compare the efficacy and tolerability of a new proton pump inhibitor, rabeprazole at two different dosages, with that of omeprazole in the healing of erosive GERD. METHODS: Rabeprazole 20 mg once daily (QD) and 10 mg twice daily (BID) were compared with omeprazole 20 mg QD in a double-blind, multicentre, parallel group study involving 310 patients with erosive GERD. The primary efficacy endpoint was oesophageal mucosal healing determined by endoscopy. Secondary endpoints included reduction in symptoms and improvements in quality-of-life scores. RESULTS: The healing rates between both rabeprazole groups and the omeprazole group were equivalent in both the per-protocol and intent-to-treat populations. In the per-protocol population, rabeprazole 20 mg was noted to have a numerical trend toward more rapid daytime heartburn relief. However, by 4 and 8 weeks of treatment, no significant differences were found between groups for secondary endpoints, adverse events, or laboratory abnormalities including elevation of serum gastrin levels. CONCLUSIONS: Rabeprazole 20 mg in two different dosing schedules is as effective as omeprazole 20 mg QD with regard to efficacy and tolerability in patients with erosive GERD.