Rabeprazole: a pharmacologic and clinical review for acid-related disorders

Dadabhai, Alia S.; Friedenberg, Frank K.

doi:10.1517/14740330802622892

Cited by 22 publications

(8 citation statements)

References 34 publications

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“…This possibly results in faster onset of action. Owing to its non-enzymatic pathway of metabolism, rabeprazole is also less influenced by genetic polymorphisms of CYP2C19 that promote metabolism of other PPIs [40]. These pharmacodynamic properties support the therapeutic effect observed in our study.…”

Section: Discussionsupporting

confidence: 88%

Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial

et al. 2020

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Background: The extraesophageal manifestations of gastroesophageal reflux disease (GERD) are more difficult to manage than the typical symptoms. The efficacy of high-dose and standard-dose proton pump inhibitors against these atypical symptoms is not yet established. Methods: In this single center, randomized, open-label study, patients with GERD received rabeprazole for 8 weeks, either 20 mg once daily (standard-dose group) or 20 mg twice daily (high-dose group). Patients were assessed before treatment and at weeks 4 and 8 with a 5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia). Sufficient improvement of reflux symptoms was defined as ≥50% reduction from the initial questionnaire score. Results: Final analyses included 35 patients in the standard-dose group and 38 patients in the high-dose group. The rate of sufficient improvement for typical symptoms was significantly higher in the high-dose group than in the standard-dose group (100.0% vs. 84.0%, P = 0.040). For atypical symptoms, the rate of sufficient improvement tended to be higher in the high-dose group than in the standard-dose group (82.4% vs. 63.0%, P = 0.087). Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes. Conclusions: High-dose rabeprazole is more effective for relieving typical GERD symptoms and some atypical symptoms such as cough and globus than a standard-dose regimen. Trial registration: This research was enrolled in a registry of clinical trials run by United States National Library of Medicine at the National Institutes of Health (ClinicalTrials.gov Protocol Registration and Results system ID: NCT04001400). This study was registered on June 26, 2019-Retrospectively registered.

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Section: Discussionsupporting

confidence: 88%

Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial

et al. 2020

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show abstract

“…This possibly results in faster onset of action. Owing to its non-enzymatic pathway of metabolism, rabeprazole is also less in uenced by genetic polymorphisms of CYP2C19 that promote metabolism of other PPIs [40]. These pharmacodynamic properties support the therapeutic effect observed in our study.…”

Section: Discussionsupporting

confidence: 85%

Efficacy of a High-Dose Proton Pump Inhibitor in Patients with Gastroesophageal Reflux Disease: A Single Center, Randomized, Open-Label Trial

Cho

Shin

Yoon

et al. 2020

Preprint

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Background: The extraesophageal manifestations of gastroesophageal reflux disease (GERD) are more difficult to manage than the typical symptoms. The efficacy of high-dose and standard-dose proton pump inhibitors against these atypical symptoms is not yet established.Methods: In this single center, randomized, open-label study, patients with GERD received rabeprazole for 8 weeks, either 20 mg once daily (standard-dose group) or 20 mg twice daily (high-dose group). Patients were assessed before treatment and at weeks 4 and 8 with a 5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia). Sufficient improvement of reflux symptoms was defined as ≥ 50% reduction from the initial questionnaire score.Results: Final analyses included 35 patients in the standard-dose group and 38 patients in the high-dose group. The rate of sufficient improvement for typical symptoms was significantly higher in the high-dose group than in the standard-dose group (100.0% vs. 84.0%, P = 0.040). For atypical symptoms, the rate of sufficient improvement tended to be higher in the high-dose group than in the standard-dose group (82.4% vs. 63.0%, P = 0.087). Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes.Conclusions: High-dose rabeprazole is more effective for relieving typical GERD symptoms and some atypical symptoms such as cough and globus than a standard-dose regimen.Trial registration: This research was enrolled in a registry of clinical trials run by United States National Library of Medicine at the National Institutes of Health (ClinicalTrials.gov Protocol Registration and Results system ID: NCT04001400). This study was registered on June 26, 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04001400.

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“…4 ICH: International Council for Harmonisation. 5 USP: united states pharmacopeia. 6 AV: acceptance value.…”

Section: Analysis Of Acid-neutralizing Capacity Based Sodium Bicarbonmentioning

confidence: 99%

“…PPIs are benzimidazole derivatives, of which rabeprazole, omeprazole, and esomeprazole are the most frequently prescribed [4]. However, unlike other PPIs, rabeprazole sodium is not affected by CYP2C19 genetic polymorphism [5][6][7], making it relatively less likely to interact with other drugs [8][9][10]. Nevertheless, rabeprazole sodium readily decomposes at acidic and neutral pH ≤ 7.0.…”

Section: Introductionmentioning

confidence: 99%

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Quality by Design Applied Development of Immediate-Release Rabeprazole Sodium Dry-Coated Tablet

Lee

Kim

2021

Pharmaceutics

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The aim of this study was to develop immediate-release oral rabeprazole sodium tablets with rapid efficacy and gastric stability for the treatment of gastroesophageal reflux disease. Rabeprazole sodium is a commonly prescribed proton pump inhibitor; however, it is extremely unstable and degrades in acidic environments. Hence, it has been manufactured and supplied only in enteric-coated tablet form, while immediate-release (IR) formulations for this drug are very limited. In this study, we applied the quality by design (QbD) approach to formulate and optimize an IR dry-coated tablet containing rabeprazole sodium as an inner core with an outer sodium bicarbonate layer to stabilize the active pharmaceutical ingredient at gastric pH. We also investigated the stability of the pharmaceutical dosage form and its pharmacokinetic profile. The results show that the developed tablets are stable for approximately 12 months and have a high dissolution rate, greater than or equal to 90% at 30 min. Further, in vivo beagle pharmacokinetics confirmed that the newly developed IR tablet had an AUCt which is bioequivalent to the existing delayed-release rabeprazole tablet; however, its Tmax was 0.5 h, which is up to seven times faster than that of the existing tablet. Moreover, the IR tablet was found to immediately absorb in the stomach. Hence, the development of IR tablets can be used as a platform to overcome the technical and commercial limitations currently associated with various proton pump inhibitors used to treat patients with gastroesophageal reflux disease that require immediate therapeutic relief.

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Rabeprazole: a pharmacologic and clinical review for acid-related disorders

Cited by 22 publications

References 34 publications

Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial

Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial

Efficacy of a High-Dose Proton Pump Inhibitor in Patients with Gastroesophageal Reflux Disease: A Single Center, Randomized, Open-Label Trial

Quality by Design Applied Development of Immediate-Release Rabeprazole Sodium Dry-Coated Tablet

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