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Tenatoprazole, a novel proton pump inhibitor with a prolonged plasma half‐life: effects on intragastric pH and comparison with esomeprazole in healthy volunteers
Author(s) -
Galmiche J. P.,
Bruley Des Varannes S.,
Ducrotté P.,
SacherHuvelin S.,
Vavasseur F.,
Taccoen A.,
Fiorentini P.,
Homerin M.
Publication year - 2004
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2004.01893.x
Subject(s) - esomeprazole , medicine , proton pump inhibitor , gastrin , washout , gastric acid , nocturnal , gastroenterology , stomach , secretion
Summary Background : Proton pump inhibitors control gastric acidity better during the day than at night, when nocturnal acid breakthrough can occur. Tenatoprazole is a novel proton pump inhibitor with a seven‐fold longer plasma half‐life. Aim : To compare the effects of tenatoprazole 20 mg (T20), tenatoprazole 40 mg (T40) and esomeprazole 40 mg (E40) on intragastric acidity in healthy volunteers. Methods : This randomized, three‐period, cross‐over study enrolled 18 Helicobacter pylori ‐negative volunteers, who received E40, T20 and T40 once daily for 7 days with a 14‐day washout between periods. Twenty‐four‐hour gastric pH monitoring was performed on day 7. Serum gastrin was assessed on day 8. Results : T40 induced a more potent acid inhibition than T20 (24‐h median pH: 4.6 vs. 4.0, P < 0.01; daytime: 4.5 vs. 3.9, P < 0.01; night‐time: 4.7 vs. 4.1, P < 0.05). T40 was more potent than E40 (24‐h median pH: 4.6 vs. 4.2, P < 0.05; night‐time: 4.7 vs. 3.6, P < 0.01); the pH > 4 holding time was higher during the night for T40 than for E40: 64.3% vs. 46.8%, P < 0.01; the nocturnal acid breakthrough duration was significantly shorter for T40 than for E40. No significant gastrin increase was observed and all drugs were well tolerated. Conclusion : T40 is significantly more potent than T20 and E40 during the night. The therapeutic relevance of this pharmacological advantage deserves further study.