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PubMed2003

Nocturnal gastric acid breakthrough during the administration of rabeprazole and ranitidine in Helicobacter pylori-negative subjects: effects of different regimens.

BACKGROUND: Nocturnal gastric acid breakthrough (NAB) is defined as nocturnal intragastric pH less than 4 for more than 1 h during proton pump inhibitor (PPI) administration. A bedtime dose of an H2 receptor antagonist (H2RA) inhibites NAB, but the efficacy of the H2RA decreases with continuous administration. We carried out the present study to investigate the effect of 14-day H2RA administration on NAB. METHODS: Ten male volunteers without Helicobacter pylori infection received four different 14-day regimens of rabeprazole and ranitidine (study a, morning dose of 20 mg rabeprazole; study b, morning dose of 20 mg rabeprazole with a single bedtime dose of 150 mg ranitidine only on the last day; study c, continuous 20 mg morning dose of rabeprazole and 150 mg at bedtime; study d, morning and evening doses of 10 mg rabeprazole). Ambulatory 24-h gastric pH monitoring was conducted on the last day of each regimen. RESULTS: NAB in studies a, b, c, and d was observed in 9, 1, 4, and 4 subjects, respectively, and the longest periods of nocturnal gastric pH at less than 4.0 were 102.5, 14.0, 37.5, and 52.5 min, respectively (study b vs study c, P<0.05). CONCLUSIONS: The continuous inhibitory effect of ranitidine combined with rabeprazole on nocturnal gastric acid secretion declined during 14-day-long administration in H. pylori-negative subjects. Split dosing of rabeprazole was more effective than the single morning dose for inhibiting nocturnal gastric acid secretion.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

Early effects of lafutidine or rabeprazole on intragastric acidity: which drug is more suitable for on-demand use?

BACKGROUND: Medication for the relief of heartburn should have the rapid onset of action required for on-demand use. We studied the inhibition of gastric acid secretion by lafutidine and rabeprazole, given in single doses to fasting and postprandial subjects. METHODS: A total of 22 healthy male, Helicobacter pylori-negative volunteers participated in this randomized, two-way crossover study. They were randomly assigned to receive a single oral dose of 10 mg lafutidine or 20 mg rabeprazole after fasting overnight (12 subjects, fasting study) or after eating a test meal (noodles, 364 kcal; protein, 10.1 g; fat, 16 g; carbohydrates, 44.9 g; NaCl, 1.1 g; 10 subjects, postprandial study). Intragastric pH was monitored continuously for 6 h after treatment. The other drug was given after a washout period of at least 7 days, and intragastric pH was similarly monitored. RESULTS: In the fasting study, lafutidine sustained pH at >3 and >4 during the second, third, fourth, fifth, and sixth hours of the study for significantly longer than rabeprazole. During the first 6 h after treatment, lafutidine sustained pH at more than 2, 3, 3.5, 4, 5, 6, and 7 longer than rabeprazole. In the postprandial study, lafutidine sustained pH >3 and >4 for longer periods than rabeprazole during the third, fourth, fifth, and sixth hours of the study. During the first 6 h after treatment, lafutidine sustained pH at more than 2, 3, 3.5, 4, 5, 6, and 7 longer than rabeprazole. CONCLUSIONS: Lafutidine 10 mg produces a prompter rise in intragastric pH than rabeprazole 20 mg in fasting and postprandial Helicobacter pylori-negative male subjects.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2002

The effects of rabeprazole on parietal cells and enterochromaffin-like cells in rats: a comparison with omeprazole.

BACKGROUND: We investigated the effects of rabeprazole compared with those of omeprazole on enterochromaffin-like cells and parietal cells in rats. METHODS: Rabeprazole or omeprazole was administered for 7 days by intraperitoneal injection (100 mg/kg or 20mg/kg once a day) and the serum gastrin concentration, the antral density of G cells and D cells, fundic histamine content, fundic H+, K+-ATPase mRNA level, and parietal cell morphology were determined. RESULTS: Both rabeprazole and omeprazole inhibited gastric acid secretion and increased the intragastric pH to over 6.5, as well as causing a marked increase in the serum gastrin concentration. The serum gastrin level was lower with rabeprazole treatment than with omeprazole treatment at both doses. Also, the antral G-cell density was higher with omeprazole than with rabeprazole, while the increase in both the histamine content and the H+, K-ATPase mRNA level in the fundic mucosa was higher with omeprazole treatment at both doses, with the difference being significant at 100 mg/kg. Ultrastructural examination indicated that the stimulation of parietal cells by omeprazole was stronger than that by rabeprazole. CONCLUSIONS: Rabeprazole treatment does not drive enterochromaffin-like cells and parietal cells as strongly as omeprazole treatment despite its potent acid suppressive effect, suggesting that it represents a new generation of proton pump inhibitors.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2001

Effects of CYP2C19 gene polymorphism on cure rates for Helicobacter pylori infection by triple therapy with proton pump inhibitor (omeprazole or rabeprazole), amoxycillin and clarithromycin in Japan.

BACKGROUND: Omeprazole is mainly metabolized by cytochrome P450 2C19 (CYP2C19) in the liver. Rabeprazole, on the other hand, is mainly metabolized to thioether-rabeprazole via a non-enzymatic pathway and partially metabolized to demethylated-rabeprazole by CYP2C19 in liver CYP2C19 status may affect cure rate for Helicobacter pylori infection with proton pump inhibitor triple therapy. AIM: To investigate whether genetic polymorphism of CYP2C19 and selected proton pump inhibitors (omeprazole or rabeprazole) were associated with cure rate for Helicobacter pylori infection using triple therapy with omeprazole or rabeprazole, amoxicillin, and clarithromycin. METHODS: A total of 170 Helicobacter pylori-positive patients with chronic gastritis were randomized to receive one of the following Helicobacter pylori eradication regimens; OAC (omeprazole 20 mg bd, amoxycillin 750 mg bd and clarithromycin 400 mg bd for 1 week) and RAC (rabeprazole 20 mg bd, amoxycillin 750 mg bd and clarithromycin 400 mg bd for 1 week). The CYP2C19 genotype; wild-type or two mutant genes (ml in exon 5 and m2 in exon 4), or both, were identified by polymerase chain reaction-restriction fragment length polymorphism. RESULTS: In DAC regimen, cure rate (per protocol analysis) was 73.3% in homozygous extensive metabolizers, 86.1% in heterozygous extensive metabolizers, and 85.0% in poor metabolizers. In RAC regimen, the cure rate was 81.0% in homozygous extensive metabolizers, 82.9% in heterozygous extensive metabolizers, and 87.5% in poor metabolizers. Cure rate was not significantly different between the CYP2C19 genotypes in both regimens. CONCLUSION: Triple therapy with proton pump inhibitor (omeprazole or rabeprazole), amoxycillin, and clarithromycin is sufficiently effective in cure of Helicobacter pylori infection regardless of CYP2C19 status.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2004

Rabeprazole 10 mg twice daily is superior to 20 mg once daily for night-time gastric acid suppression.

BACKGROUND: Insufficient acid suppression is one of the main causes of proton pump inhibitor-refractory gastro-oesophageal reflux disease. AIM: To achieve more potent and long-lasting acid suppression, different dosage regimens of rabeprazole were compared in relation to the CYP2C19 genotype status. METHODS: In a cross-over study, 18 healthy Helicobacter pylori-negative males (six homozygous extensive metabolizers, six heterozygous extensive metabolizers and six poor metabolizers) were given rabeprazole 10 mg once daily, 20 mg once daily or 10 mg twice daily, or water only (baseline data), for 7 days each. On day 7 of each regimen, 24-h intragastric pH-metry was performed. RESULTS: No significant differences were observed in median pH values and pH>4 holding time ratios between rabeprazole 10 mg once daily and 20 mg once daily. However, with rabeprazole 10 mg twice daily, these parameters were significantly higher than those with 20 mg once daily. The potency of acid suppression by rabeprazole was influenced by the CYP2C19 genotype status. The differences were somewhat significant but not large. The incidence of nocturnal acid breakthrough was lowest with rabeprazole 10 mg twice daily. CONCLUSIONS: Rabeprazole 10 mg twice daily, not 20 mg once daily, should be administered to achieve more potent and long-lasting acid suppression.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

Long-term treatment of gastro-oesophageal reflux disease patients with frequent symptomatic relapses using rabeprazole: on-demand treatment compared with continuous treatment.

BACKGROUND: On-demand treatment may be an alternative in the long-term treatment of non-severe gastro-oesophageal reflux disease in patients with frequent symptomatic relapses. AIM: To compare the efficacy of on-demand treatment with rabeprazole 10 mg versus continuous treatment in the long-term treatment of patients with frequent symptomatic relapses of mild to moderate gastro-oesophageal reflux disease. METHODS: This randomized, open-label study enrolled patients diagnosed with non-erosive reflux disease or oesophagitis grade 1 or 2 (Savary-Miller classification) reporting frequent symptomatic relapses (requiring > or =2 courses of antisecretory therapy during the previous year), whose intensity is rated at least moderate (>2 on a 5-point Likert scale). After a 4-week selection phase with rabeprazole 10 mg once daily, patients reporting symptom relief (Likert score < or =2) were randomized to receive either rabeprazole 10 mg continuous treatment or on-demand treatment for 6 months. The main evaluation criterion was the rate of symptom relief (scored on the Likert scale) after 6 months. RESULTS: One hundred and seventy-six patients were enrolled in the 4-week selection phase (men, 53%; mean age, 49 years; non-erosive reflux disease, 36.4%; gastro-oesophageal reflux disease 1, 53.4%; gastro-oesophageal reflux disease 2, 10.2%). Rabeprazole relieved symptoms in 88.6% of patients. Of this group, 152 were randomized to the comparative phase to receive rabeprazole 10 mg continuous treatment (once daily) or on-demand treatment (continuous treatment, n = 81; on-demand treatment, n = 71). At month 6 (end point), the symptom relief rate was slightly higher for patients in the continuous treatment group compared with those in the on-demand treatment group: 86.4% versus 74.6%, respectively. This difference was not statistically significant (P = 0.065). For the overall quality of life score, there was no difference between the continuous treatment and on-demand treatment groups (86.25 and 84.94). Mean daily consumption of rabeprazole was significantly lower in the on-demand treatment group versus the continuous treatment group (0.31 tablets versus 0.96 tablets; P < 0.0001). CONCLUSION: On-demand therapy with rabeprazole 10 mg provides an alternative to continuous therapy in patients with mild to moderate gastro-oesophageal reflux disease suffering from frequent symptomatic relapses.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

The effect of rabeprazole on regional gastric acidity and the postprandial cardia/gastro-oesophageal junction acid layer in normal subjects: a randomized, double-blind, placebo-controlled study.

BACKGROUND: Postprandial intragastric acidity is not uniform. Postprandial proximal gastric acid pockets have been described in the present study. AIM: To determine the effects of rabeprazole on regional intragastric acidity and proximal acid pockets. METHODS: Ten normal subjects underwent two 8-day oral dosing regimens with placebo or rabeprazole 20 mg each morning in a randomized, double-blind protocol. Oesophago-gastric pH monitoring was performed on days 1 and 8. RESULTS: Rabeprazole increased fasting and postprandial gastric pH to above 4 in each area of the stomach on days 1 and 8. With placebo, acid pockets were identified at the cardia/gastro-oesophageal junction in 62 and 50 of 150 pull-throughs on days 1 and 8, respectively. Acid pockets were detected postprandially 3.1 +/- 0.2-5.8 +/- 0.1 cm below the proximal border of the lower oesophageal sphincter with a mean pH drop from 4.6 +/- 0.1 to 1.5 +/- 0.1. Rabeprazole decreased the number of acid pockets to 30 and 27 on days 1 and 8, respectively. Rabeprazole also decreased their length and magnitude of the pH drop. CONCLUSIONS: Rabeprazole increased intragastric pH on day 1 and 8 and maintained an elevated pH during and after meals. Postprandial acid pockets, identified in the region of the cardia/gastro-oesophageal junction area postprandially, were decreased in number, length and magnitude by rabeprazole.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1995

Helicobacter pylori urease inhibition by rabeprazole, a proton pump inhibitor.

We investigated the inhibitory effects of four gastric proton pump inhibitors (PPIs): rabeprazole, a novel benzimidazole PPI, omeprazole, lansoprazole and AG-2000, on the urease activity of Helicobacter pylori (H. pylori). Their 50% inhibitory concentrations (I50s) were found to be 0.29, 5.4, 9.3 and 0.3 microM respectively. Rabeprazole and omeprazole were also potent inhibitors of Jack bean and Proteus mirabilis cellular ureases. The thioether derivative of rabeprazole, one of its metabolites, had no inhibitory effect on H. pylori urease, despite being reported as a more potent inhibitor of H. pylori growth than rabeprazole. The inhibitory effect of rabeprazole was prevented completely and reversed considerably by the addition of sulfhydryl compounds, such as beta-mercaptoethanol, glutathione and dithiothreitol. Moreover, the addition of beta-mercaptoethanol recovered the urease activity inhibited by rabeprazole. From these results, we expected that rabeprazole inhibited H. pylori urease activity by forming disulfide bonds between it and the active site of the enzyme.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

Rabeprazole: the role of proton pump inhibitors in Helicobacter pylori eradication.

Proton pump inhibitors have become one of the cornerstones in the treatment of Helicobacter pylori infection. Rabeprazole (Pariet) is a substituted benzimidazole proton pump inhibitor with potent gastric acid suppression properties. Its high acid-base dissociation constant allows activation over a broader pH range, resulting in quick, irreversible binding to the H+/K+-ATPase pump, and a more rapid onset of action compared with omeprazole, lansoprazole and pantoprazole. Unlike other proton pump inhibitors, the metabolism of rabeprazole is primarily via a nonenzymatic reduction to the thioether derivative, and the cytochrome P450 isoenzyme 2C19 is only partly involved in its metabolism. The effect of genetic polymorphism in cytochrome P450 isoenzyme 2C19 on the pharmacokinetics and pharmacodynamics of rabeprazole is therefore limited. In humans, once-daily dosing of 5-40 mg of rabeprazole inhibits gastric acid secretion in a dose-dependent manner. In vitro studies have shown that rabeprazole possesses more potent antibacterial properties against the growth of H. pylori than other proton pump inhibitors. Furthermore, its thioether derivative has more potent inhibitory in vitro activity against the growth and motility of clarithromycin-resistant H. pylori than other proton pump inhibitors or commonly used antimicrobials. Despite these inherent favorable characteristics of rabeprazole, randomized controlled trials have largely shown equivalence amongst proton pump inhibitors when used with two antibiotics in the eradication of H. pylori, with cure rates of 75-89% on an intent-to-treat basis. However, rabeprazole appears to consistently achieve such comparable eradication rates even when used at reduced doses (10 mg twice daily) as part of clarithromycin-based triple therapy.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2006

Comparison of the effects of single and repeated oral doses of lansoprazole and rabeprazole on ambulatory 24-hour intragastric pH in healthy volunteers.

BACKGROUND: As the comparative pharmacokinetics and pharmacodynamics of lansoprazole and rabeprazole have not previously been studied, we set out in this study to compare the pharmacokinetics and pharmacodynamics of single and repeated daily doses of lansoprazole 15 mg and 30 mg with those of rabeprazole 10 mg and 20 mg. METHODS: This was an open-label, randomised, crossover, two-centre study in 72 healthy volunteers. Each subject received each of the four treatments for 5 days, with 2-week washout periods. Continuous 24-hour intragastric pH and pharmacokinetics were studied on days 1 and 5. RESULTS: Mean 24-hour pH and percentage time for pH > 4 were not significantly different between lansoprazole 30 mg and rabeprazole 20 mg. Mean 24-hour pH and percentage time for pH > 4 were significantly greater after lansoprazole 30 mg and rabeprazole 20 mg than after lansoprazole 15 mg and rabeprazole 10 mg, respectively. Lansoprazole resulted in greater acid suppression during hours 0-5 on days 1 and 5, whereas rabeprazole had greater suppression during hours 11-24 on day 5. Time to maximum plasma concentration was significantly shorter for lansoprazole on both days. CONCLUSION: Lansoprazole had a consistently faster onset of action, whereas rabeprazole had a greater effect during the evening hours after 5 days of administration.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2006

Pharmacodynamic and kinetic effect of rabeprazole on serum gastrin level in relation to CYP2C19 polymorphism in Chinese Hans.

AIM: To observe the pharmacokinetics and pharmaco-dynamics of rabeprazole and compare serum gastrin concentrations in different CYP2C19 genotype groups. METHODS: The CYP2C19 genotype status of Chinese Han healthy volunteers was determined by polymerase chain reaction-restriction fragment length polymorphism method. Twenty H pylori-negative healthy subjects voluntary participated in the study. They were divided into the following three groups: homozygous extensive metabolizers (homEM), heterozygous extensive metabolizers (hetEM) and poor metabolizers (PM). After they orally received rabeprazole 20 mg once daily in the morning of d 1 and d 8, blood samples were collected at various time-points until 24 h after administration and intragastric pH values were monitored for 24 h by Digitrapper pH. Serum gastrin concentrations were measured by radioimmunoassay. Serum concentrations of rabeprazole were measured by high performance liquid chromatography. RESULTS: The mean AUC values for rabeprazole after a single and repeated doses were significantly different between the homEM and PM groups, but not between the homEM and hetEM, or the hetEM and PM groups. No significant differences in intragastric pH medians were observed among the three different genotype groups after a single dose or repeated doses. The ratio of pH medians between d 1 and d 8 ranged from 84% to 108%. The mean gastrin AUC values were also different among the three genotype groups, with a relative ratio of 1.0, 1.2 and 1.5 after a single dose and 1.0, 1.5 and 1.6 after repeated doses in the homEM, hetEM and PM groups, respectively. The gastrin AUC values among the three different genotype groups showed no significant difference either after a single dose or repeated doses. The subject who had lower intragastric acidity showed higher serum gastrin levels and concentrations of rabeprazole. CONCLUSION: In Chinese Han healthy people, the pharmacokinetics of rabeprazole are dependent on the CYP2C19 genotype status, but acid-inhibitory efficacy of rabeprazole and the gastrin level are not influenced significantly.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

Pharmacokinetics of rabeprazole following single intravenous and oral administration to healthy subjects.

The study was designed to determine the absolute bioavailability of 20 mg rabeprazole tablets in normal, healthy subjects in comparison with intravenous administration of 20 mg rabeprazole. Twenty-eight healthy subjects were enrolled in this study. The study was a randomized, balanced, open-label, 2-period crossover study. Each subject was randomized at the beginning of the study to receive either a single 20 mg dose of rabeprazole intravenously or orally during Period 1. Following a 7-day washout period, all subjects received the alternate formulation during Period 2. Intravenous dose was given in constant infusion over five minutes. The absolute bioavailability of rabeprazole was 51.8%. The elimination half-life of rabeprazole sodium (1.47 +/- 0.82 h) after oral administration was significantly longer than the elimination half-life after intravenous administration (1.02 +/- 0.63 h), probably due to slower rate of absorption than that of elimination. The mean total body clearance was 283 +/- 98 ml/minutes following a 20 mg intravenous dose. The administration of rabeprazole sodium was safe as evidenced by the lack of serious adverse events and the rapid resolution of the mostly mild adverse events that occurred during the study. Both treatments were well-tolerated throughout the study. Rabeprazole was well-absorbed after oral administration.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2000

Cytoprotective effect of rabeprazole against ethanol-induced gastric mucosal damage: possible involvement of nitric oxide.

The cytoprotective effect of rabeprazole, a new proton pump inhibitor, against ethanol-induced gastric mucosal damage was investigated in rats. Rats received intraperitoneal injections of rabeprazole once only or once daily for 3 days. Subsequently, the rats were given 1 ml of absolute ethanol by oral intubation. Some rats given rabeprazole were treated with N-omega-nitro-L-arginine methyl ester (L-NAME) or indomethacin. Repeated administration of rabeprazole significantly inhibited ethanol-induced gastric mucosal damage, although single administration of this drug did not. Pretreatment with L-NAME abolished the cytoprotective effect of rabeprazole. This inhibitory effect of L-NAME was reversed by L-arginine but not by D-arginine. Pretreatment with indomethacin did not influence the cytoprotective effect of rabeprazole. These results suggest that repeated intraperitoneal administration of rabeprazole has a cytoprotective effect against ethanol-induced gastric mucosal damage and that this effect may be mediated via nitric oxide but not via prostaglandins.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2002

Rabeprazole: pharmacokinetics and pharmacokinetic drug interactions.

Rabeprazole is the most recently approved proton pump inhibitor in Germany. The substance has an absolute bioavailability upon oral administration of approximately 52% which is robust against food intake or administration of antacids. Maximal plasma concentrations are reached after approximately 3-4 h. Concentrations increase proportionally with the dose. Rabeprazole undergoes an almost complete, mainly non-enzymatic metabolism with renal elimination of the metabolites. CYP3A4 and CYP2C19 contribute to the fraction of metabolism mediated enzymatically. Elimination half-life is about 1 h. The extent of rabeprazole concentration increase by old age, poor metabolizer status for CYP2C19 and impairment of liver function is not greater than two-fold, impaired renal function does not affect the elimination. Even in patients with delayed elimination, no relevant accumulation of rabeprazole was observed upon long-term administration. In in vivo studies, rabeprazole had no noteworthy effect on the metabolism of other drugs. This statement however must be made with reservation because of shortcomings in published studies with respect to the methods used and presentation and because of lacking investigations about possible effects on the cytochrome P-450 enzymes CYP3A4 and CYP2D6. A slight reduction in ketoconazole absorption and a moderate increase in digoxin concentrations should be taken into account for concomitant therapy, but is expected to be clinically relevant only in isolated cases. Based on these partially incomplete data, in summary it is to be expected that rabeprazole can be administered at a standard dose for the respective disease in almost any patient for the entire duration of therapy, and that usually no dose adjustment of other drugs is required when rabeprazole is coadministered.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2003

[Comparative effectiveness of the antisecretory action of rabeprazole and esomeprazole in people with rapid metabolism of proton pump inhibitors].

AIM: To compare antisecretory effects of Rabeprazole and Esomeprazole in proton pump inhibitors extensive metabolizers in an open, randomized, two-way crossover study. METHODS: Sixteen GERD H. pylori-positive patients (8 men, mean age 49.6 and 8 women, mean age 49.3) with the homozygous extensive metabolizer genotype of CYP2C19 determined by polymerase chain reaction-restriction fragment length polymorphism analysis received Rabeprazole 20 mg or Esomeprazole 20 mg daily on days 1-6, with a 14-day wash-out period. Intragastric pH was recorded continuously on days 0, 1, 5 and 7. RESULTS: On days 1 and 5 no differences were found between Rabeprazole 20 mg and Esomeprazole 20 mg in 24-hours median pH (day 1: 5.9 versus 5.0; day 5: 6.45 versus 6.3) or in percent of time with pH 4 (day 1: 57.8% versus 50.5%; day 5: 81.4% versus 81.2%). On day 1, mean percent of time pH 4 were significantly greater after Esomeprazole 20 mg 52.6% (95% CI: 23.6-68.2) than Rabeprazole 20 mg 33.0% (95% CI: 15.3-48.2) during 0-6 h (p = 0.02). On day 7 (24 later the last dose), 24-hours median pH was higher after Esomeprazole 20 mg than Rabeprazole 20 mg (2.7 versus 5.05; p = 0.02). CONCLUSIONS: Rabeprazole 20 mg and Esomeprazole 20 mg are equally effective in increasing gastric pH in H. pylori-positive PPI extensive metabolizers on days 1 and 5. Esomeprazole 20 mg is more effective than Rabeprazole 20 mg in maintaining pH 4 during the first 6 hours on the first day and increasing of intragastric pH on the day 24 hours later the last dose.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2003

A randomized, double-blind trial of the efficacy and safety of 10 or 20 mg rabeprazole compared with 20 mg omeprazole in the maintenance of gastro-oesophageal reflux disease over 5 years.

BACKGROUND: Gastro-oesophageal reflux disease has a chronic course, and often requires long-term treatment. Proton pump inhibitors are the treatment of choice for both acute and maintenance treatment, but little is known from randomized controlled trials of their effects beyond 1 year. AIM: To compare the efficacy and safety of two doses of rabeprazole with 20 mg omeprazole in the maintenance treatment of erosive gastro-oesophageal reflux disease over 5 years. METHODS: Two hundred and forty-three patients who had previously responded to acute treatment for erosive gastro-oesophageal reflux disease were prospectively randomized to receive 5 years of treatment with rabeprazole (10 or 20 mg daily) or omeprazole (20 mg daily). The primary outcome measure was endoscopically confirmed relapse of erosive gastro-oesophageal reflux disease. RESULTS: One hundred and twenty-three patients (51%) completed all 5 years of the study, with similar completion rates in the three groups. Relapses occurred in nine of 78 (11.5%), eight of 82 (9.8%) and 11 of 83 (13.3%) patients in the rabeprazole 20 mg, rabeprazole 10 mg and omeprazole 20 mg groups, respectively. Gastric biopsy showed no evidence of any harmful effects. All treatments were well tolerated. CONCLUSIONS: Rabeprazole 10 mg, rabeprazole 20 mg and omeprazole 20 mg all had similar efficacy in the maintenance treatment of gastro-oesophageal reflux disease. All three were safe and well tolerated during 5 years of treatment.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

[The clinical applications of rabeprazole either alone or combined with anti-Helicobacter pylori agents in peptic ulcer patients].

OBJECTIVE: To study the efficacy and safety of rabeprazole in peptic ulcer patients alone or combined with anti-Helicobacter pylori (Hp) agents. METHODS: An open labeled multi-center clinical trial was designed. Different types peptic ulcer patients identified by endoscopy were recruited from 24 provinces and cities in China. They were given rabeprazole alone 10 mg/d for 7 days continuously (rabeprazole alone group), or combined anti-Hp protocol (including rabeprazole 10 mg, b.i.d., 5 or 7 days) (combination group) respectively by doctors according to their disease situations. Their symptoms and side effects during the therapy were recorded. RESULTS: This study included 25 609 patients in total with 11 386 in rabeprazol alone group and 14 223 in combination and following diseases as gastric ulcer, duodenal ulcer, complex ulcer, esophageal ulcer, stress ulcer and anastomotic ulcer. The effective rates relieving epigastric pain was 63.0%, 91.2%, 99.2% and 99.7%, respectively, with elimination rates of 16.0%, 47.8%, 80.3%, 94.8%, respectively on the 1st, 2nd, 5th and 7th day. The effective rate to relieve all symptoms on the 1st, 2nd, 5th and 7th day was 42.0%, 78.0%, 93.1% and 98.3%. No statistical differences between rabeprazole alone group and combined group. 476 patients (1.9%) developed mild side effects during the therapy, labeprazole alone group of 147 (1.3%), and combined group of 329 (2.3%), P < 0.01. No severe side effects occurred. CONCLUSIONS: Whether labeprazole was used alone or combined with anti-Hp agents, it is an effective and safe therapy for the treatment of peptic ulcer.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

Efficacy of rabeprazole in the treatment of symptomatic gastroesophageal reflux disease.

The purpose of this study was to assess the rapidity of symptom relief and 4-week efficacy of rabeprazole 20 mg in patients with moderately severe nonerosive gastroesophageal reflux disease. Data were analyzed from 2 similarly designed, double-blind, placebo-controlled, multicenter, U.S. trials. After a 2-week placebo run-in period, patients (N = 261) were randomized to 4 weeks of rabeprazole 20 mg once daily or placebo. Patients kept symptom diaries and scored symptom severity. Median time to first 24-hour heartburn-free interval was 3.5 days for the rabeprazole group compared with 19.5 days for the placebo group (P < or = .0002). Complete heartburn relief at week 4 was 32% with rabeprazole and 3.8% with placebo (P < or = .001). Rabeprazole also significantly improved other GERD-associated symptoms (e.g., regurgitation, belching, early satiety) by week 4 compared with placebo (P < or = .05). Rabeprazole provides fast and potent relief from heartburn and other symptoms of nonerosive gastroesophageal reflux disease.

2-Pyridinylmethylsulfinylbenzimidazoles↗