Rabeprazole's tolerability profile in clinical trials

Alimentary Pharmacology and Therapeutics, Supplement

Volumn 13, Issue 5, 1999, Pages 17-23

  Thjodleifsson, B ^a   Cockburn, I ^b  

^a LANDSPITALI UNIVERSITY HOSPITAL   (Iceland)

^b EISAI CO LTD   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

HISTAMINE H2 RECEPTOR ANTAGONIST; OMEPRAZOLE; PROTON PUMP INHIBITOR; RABEPRAZOLE; 2 [[(2 PYRIDYL)METHYL]SULFINYL]BENZIMIDAZOLE DERIVATIVE; ANTIULCER AGENT; BENZIMIDAZOLE DERIVATIVE; DRUG DERIVATIVE; ENZYME INHIBITOR;

ABDOMINAL PAIN; ADULT; AGED; BACKACHE; CLINICAL TRIAL; DIARRHEA; DRUG TOLERABILITY; FLU LIKE SYNDROME; GASTROESOPHAGEAL REFLUX; HEADACHE; HUMAN; INSOMNIA; LIVER DISEASE; MAJOR CLINICAL STUDY; META ANALYSIS; NAUSEA; ORAL DRUG ADMINISTRATION; PHARYNGITIS; PRIORITY JOURNAL; REVIEW; RHINITIS; SIDE EFFECT; SINUSITIS; VOMITING; CONTROLLED CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ANTI-ULCER AGENTS; BENZIMIDAZOLES; CLINICAL TRIALS; ENZYME INHIBITORS; HUMANS; OMEPRAZOLE; RANDOMIZED CONTROLLED TRIALS;

EID: 0032880881     PISSN: 09530673     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (39)

1. Sanders SW. Pathogenesis and treatment of acid peptic disorders: comparison of proton pump inhibitors with other antiulcer agents. Clin Ther 1996; 18: 2-35.
2. Prakash A, Faulds D. Rabeprazole. Drugs 1998; 55: 261-7.
3. Huang JQ, Hunt RH. pH, healing rate and symptom relief in acid-related diseases. Yale J Biol Med 1996; 69: 159-74.
4. Dekkers CPM, Beker JA, Thjodleifsson B, et al. Comparison of rabeprazole 20 mg versus omeprazole 20 mg in the treatment of active duodenal ulcer: a European multicentre study. Aliment Pharmacol Ther 1999; 13: 179-86.
5. Dekkers CPM, Beker JA, Thjodleifsson B, et al. Double-blind, placebo-controlled comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. Aliment Pharmacol Ther 1999; 13: 49-57.
6. Dekkers CPM, Beker JA. Thjodleifsson B, et al. Comparison of rabeprazole 20 mg vs omeprazole 20 mg in the treatment of active gastric ulcer - a European multicentre study. Aliment Pharmacol Ther 1998; 12: 789-95.
7. Freston JW, Malagelada JR, Petersen H, et al. Critical issues in the management of gastroesophageal reflux disease. Eur J Gastroenterol Hepatol 1995; 7: 577-86.
8. Humphries TJ, Spera A, Breiter J, et al. Rabeprazole sodium (E3810) once daily is superior to ranitidine 150 mg QID in the healing of erosive or ulcerative gastroesophageal reflux disease. Gastroenterology 1996; 110: A139 (Abstract).
9. Birbara C, Breiter J, Collins D, et al. Rabeprazole: preventing endoscopic and symptomatic relapse in erosive or ulcerative GERD. Am J Gastroenterol 1998; 93: 1630 (Abstract).
10. Caos A, Moskovitz M, Perdomo C, Niecestro R, Hahne W. Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease. Gastroenterology 1999; 116: A132 (Abstract).
11. Breiter J, Birbara C, Niecestro R, Perdomo C, Hahne W. Rabeprazole prevents recurrence of pathology and symptoms in patients with healed erosive or ulcerative gastroesophageal reflux disease. Gastroenterology 1999; 116: A128 (Abstract).
12. Humphries TJ, Dekkers CPM, Beker JA, et al. Rabeprazole vs omeprazole for maintenance therapy of healed erosive GERD: results of a 1-year European multicenter trial. Am J Gastroenterol 1998; 93: 1616 (Abstract).
13. Johnson D, Riff R, Perdomo C, et al. Rabeprazole: safety profile of a new proton pump inhibitor. Gastroenterology 1999; 116: A201 (Abstract).
14. Cloud ML, Enas M, Humphries TJ, et al. 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). The Rabeprazole Study Group. Dig Dis Sci 1998; 43: 993-1000.
15. Cloud ML, Olovich K, Enas N, et al. LY307640 versus placebo in healing erosive, ulcerative reflux esophagitis. Gastroenterology 1995; 108: A73 (Abstract).
16. Cloud ML, Olovich K, Enas N, Bassion S, Humphries T. LY307640 versus placebo in healing duodenal ulcers. Gastroenlerology 1995; 108: A73 (Abstract).
17. Humphries TJ, Cloud ML, Enas N, Bassion S, McNamara M, and the US Rabeprazole Gastric Ulcer Study Group. Rabeprazole (E3810, LY307640) achieves high rates of healing in active gastric ulcer. Gastroenterology 1996; 110: A138 (Abstract).
18. VantlenBranden M, Ring BJ, Binkley SN, Wrighton SA. Interaction of human liver cytochromes P450 in vitro with LY307640, a gastric proton pump inhibitor. Pharmacogenetics 1996; 6: 81-91.
19. Humphries TJ, Nardi RV, Lazar JD, Spanyers SA. Drug-drug interaction evaluation of rabepranole sodium: a clean/ expected slate? Gut 1996; 39 (Suppl. 3): A47 (Abstract).
20. Humphries TJ, Spera A, Breiter A, et al. Rabeprazole sodium once daily is superior to ranitidine 150 mg bid in the healing of active duodenal ulcer. Gastroenterology 1997; 112: A154 (Abstract).
21. Humphries TJ, Keane WF, St. Peter JV, et al. Rabeprazole: safety, tolerance, and pharmacokinetics in patients with renal dysfunction. Am J Gastroenterol 1998; 93: 1638 (Abstract).
22. Hoyumpa AM, Trevino-Alanis H, Grimes I, Humphries TJ. Rabeprazole: pharmacokinetics in patients with stable, compensated cirrhosis. Clin Ther 1999; 21: 691-701.
23. 2-receptor antagonists. N Engl J Med 1990; 323: 1672-80.
24. Holt S. Proton-pump inhibition for acid-related disease. South Med J 1991; 84: 1078-87.
25. Castot A, Bidault I, Dahan R, Efthymiou ML. Evaluation of unexpected and toxic effects of omeprazole (Mopral) reported to the regional centers of pharmacovigilance during the first 22 postmarketing months. Therapie 1993; 48: 469-74.
26. Lloyd-Davies KA, Rutgersson K, Solvell L. Omeprazole in the treatment of Zollinger-Ellison syndrome: a 4-year international study. Aliment Pharmacol Ther 1988; 2: 13-32.
27. Lind T, Cederberg C, Forssell H, et al. Relationship between reduction of gastric acid secretion and plasma gastrin concentration during omeprazole treatment. Scand J Gastroenterol 1988; 23: 1259-66.
28. Motomura A, Arita M, Sakurai T, et al. An open, randomized dose-response trial of two doses of E3810 (rabeprazole sodium) in patients with duodenal or gastric ulcers, with 24 hour gastric pH monitoring in gastric ulcer patients [in Japanese]. Mod Physician 1994; 14: 23-37.
29. Lew EA, Barbuti RC, Kovacs TOG, et al. An ascending single-dose safety and tolerance study of an oral formulation of rabeprazole (E3810). Aliment Pharmacol Ther 1998; 12: 667-72.
30. Breiter JR, Sabesin S, Gardner JD, et al. Rabeprazole relieves heartburn as rapidly as ranitidine and is more effective. Gastroenterology 1999; 116: A128 (Abstract).
31. Humphries TJ, Dekkers C, Beker J, et al. Magnitude of changes in fasting serum gastrin in 211 patients taking raheprazole 10 ing or 20 mg or omeprazole 20 mg for one year. Am J Gastroenterol 1998; 93: 1637 (Abstract).
32. Dammann HG, Burkhardt F, Bell NE, Rjaaland T. Rabeprazole does not affect endocrine function in healthy subjects. Am J Gastroenterol 1996; 91: 1909 (Abstract).
33. Havu N. Enterochromaffin-like cell carcinoids of gastric mucosa in rats after life-long inhibition of gastric secretion. Digestion 1986; 35 (Suppl. 1): 42-55.
34. McTavish D, Buckley MMT, Heel RC. Omeprazole. An updated review of its pharmacology and therapeutic use in acid-related disorders. Drugs 1991; 42: 138-70.
35. Humphries TJ, Rindi G, Fiocca R. Argyrophil ECL cell histology in the gastric corpus and antrum in 243 patients taking rabeprazole 10 mg or 20 mg for one year. Am J Gastroenterol 1998; 93: 1637 (Abstract).
36. Humphries T, Rindi G, Fiocca R. Histological evaluation of H. pylori, gastritis, gastric atrophy and intestinal metaplasia in the gastric corpus antrum of 243 patients taking rabeprazole 10 mg or 20 mg or omeprazole 20 mg for one year. Am J Gastroenterol 1998; 93: 1637 (Abstract).
37. Ishizaki T, Chiba K, Manabe K, et al. Comparison of the interaction potential of a new proton pump inhibitor, E3810, versus omeprazole with diazepam in extensive and poor metabolizers of S-mephytoin 4′-hydoxylation. Clin Pharmacol Ther 1995; 58: 155-64.
38. Humphries TJ, Nardi RV, Spera JD, Lazar JD, Laurent AL. Coadministration of rabeprazole sodium (E3810) does not affect the pharmacokinetics of anhydrous theophylline or warfarin. Gastroenterology 1996; 110 (Suppl.): 138 (Abstract).
39. Humphries TJ, Spera AC, Laurent AL, Spanyers SA. Rabeprazole sodium (E3810) 20 mg daily does not affect the pharmacokinetics of phenytoin sodium in normal volunteers. Am J Gastroenterol 1996; 91: 1914 (Abstract).