Effect on Intragastric pH of a PPI with a Prolonged Plasma Half-Life: Comparison between Tenatoprazole and Esomeprazole on the Duration of Acid Suppression in Healthy Male Volunteers
To compare the inhibitory effect of a novel proton pump inhibitor (PPI), tenatoprazole 40 mg once daily, with esomeprazole 40 mg once daily on intragastric acidity. A randomized, investigator-blind, two-way, crossover study was conducted in 30 healthy Helicobacter pylori negative male volunteers. Te...
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Published in | The American journal of gastroenterology Vol. 100; no. 9; pp. 1949 - 1956 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford
Blackwell Publishing
01.09.2005
Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins |
Subjects | |
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Abstract | To compare the inhibitory effect of a novel proton pump inhibitor (PPI), tenatoprazole 40 mg once daily, with esomeprazole 40 mg once daily on intragastric acidity.
A randomized, investigator-blind, two-way, crossover study was conducted in 30 healthy Helicobacter pylori negative male volunteers. Tenatoprazole 40 mg or esomeprazole 40 mg was administered once daily for 7 consecutive days with a 4-wk washout period between treatments. Ambulatory 24-h intragastric pH was recorded at baseline, after 7 days' treatment, and 3 and 5 days after treatment was stopped.
At presumed steady-state (day 7), median 24-h pH values were 5.02 and 4.79 for tenatoprazole and esomeprazole, respectively. There was a significant difference between tenatoprazole and esomeprazole during the nocturnal period when mean pH was 4.64 +/- 0.67 versus 3.61 +/- 0.90, respectively (p < 0.0001), as well as a significantly higher mean percentage of time with pH >4 on tenatoprazole (72.5 +/- 14.9 vs 62.2 +/- 13.6, p < 0.0001). The effect of tenatoprazole was still present 5 days after treatment withdrawal especially during the night-time. The mean area under the plasma concentration-time curve and elimination half-time was significantly higher in the tenatoprazole group as compared with the esomeprazole group.
Tenatoprazole 40 mg daily provides a prolonged duration of acid suppression and a shorter nocturnal acid breakthrough in healthy volunteers, even after stopping the drug. Thus, tenatoprazole may provide greater clinical efficacy for patients in whom a once daily PPI is ineffective. Further studies are indicated. |
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AbstractList | OBJECTIVETo compare the inhibitory effect of a novel proton pump inhibitor (PPI), tenatoprazole 40 mg once daily, with esomeprazole 40 mg once daily on intragastric acidity.METHODSA randomized, investigator-blind, two-way, crossover study was conducted in 30 healthy Helicobacter pylori negative male volunteers. Tenatoprazole 40 mg or esomeprazole 40 mg was administered once daily for 7 consecutive days with a 4-wk washout period between treatments. Ambulatory 24-h intragastric pH was recorded at baseline, after 7 days' treatment, and 3 and 5 days after treatment was stopped.RESULTSAt presumed steady-state (day 7), median 24-h pH values were 5.02 and 4.79 for tenatoprazole and esomeprazole, respectively. There was a significant difference between tenatoprazole and esomeprazole during the nocturnal period when mean pH was 4.64 +/- 0.67 versus 3.61 +/- 0.90, respectively (p < 0.0001), as well as a significantly higher mean percentage of time with pH >4 on tenatoprazole (72.5 +/- 14.9 vs 62.2 +/- 13.6, p < 0.0001). The effect of tenatoprazole was still present 5 days after treatment withdrawal especially during the night-time. The mean area under the plasma concentration-time curve and elimination half-time was significantly higher in the tenatoprazole group as compared with the esomeprazole group.CONCLUSIONTenatoprazole 40 mg daily provides a prolonged duration of acid suppression and a shorter nocturnal acid breakthrough in healthy volunteers, even after stopping the drug. Thus, tenatoprazole may provide greater clinical efficacy for patients in whom a once daily PPI is ineffective. Further studies are indicated. To compare the inhibitory effect of a novel proton pump inhibitor (PPI), tenatoprazole 40 mg once daily, with esomeprazole 40 mg once daily on intragastric acidity. A randomized, investigator-blind, two-way, crossover study was conducted in 30 healthy Helicobacter pylori negative male volunteers. Tenatoprazole 40 mg or esomeprazole 40 mg was administered once daily for 7 consecutive days with a 4-wk washout period between treatments. Ambulatory 24-h intragastric pH was recorded at baseline, after 7 days' treatment, and 3 and 5 days after treatment was stopped. At presumed steady-state (day 7), median 24-h pH values were 5.02 and 4.79 for tenatoprazole and esomeprazole, respectively. There was a significant difference between tenatoprazole and esomeprazole during the nocturnal period when mean pH was 4.64 +/- 0.67 versus 3.61 +/- 0.90, respectively (p < 0.0001), as well as a significantly higher mean percentage of time with pH >4 on tenatoprazole (72.5 +/- 14.9 vs 62.2 +/- 13.6, p < 0.0001). The effect of tenatoprazole was still present 5 days after treatment withdrawal especially during the night-time. The mean area under the plasma concentration-time curve and elimination half-time was significantly higher in the tenatoprazole group as compared with the esomeprazole group. Tenatoprazole 40 mg daily provides a prolonged duration of acid suppression and a shorter nocturnal acid breakthrough in healthy volunteers, even after stopping the drug. Thus, tenatoprazole may provide greater clinical efficacy for patients in whom a once daily PPI is ineffective. Further studies are indicated. OBJECTIVE:To compare the inhibitory effect of a novel proton pump inhibitor (PPI), tenatoprazole 40 mg once daily, with esomeprazole 40 mg once daily on intragastric acidity.METHODS:A randomized, investigator-blind, two-way, crossover study was conducted in 30 healthy Helicobacter pylori negative male volunteers. Tenatoprazole 40 mg or esomeprazole 40 mg was administered once daily for 7 consecutive days with a 4-wk washout period between treatments. Ambulatory 24-h intragastric pH was recorded at baseline, after 7 days' treatment, and 3 and 5 days after treatment was stopped.RESULTS:At presumed steady-state (day 7), median 24-h pH values were 5.02 and 4.79 for tenatoprazole and esomeprazole, respectively. There was a significant difference between tenatoprazole and esomeprazole during the nocturnal period when mean pH was 4.64 ± 0.67 versus 3.61 ± 0.90, respectively (p < 0.0001), as well as a significantly higher mean percentage of time with pH >4 on tenatoprazole (72.5 ± 14.9 vs 62.2 ± 13.6, p < 0.0001). The effect of tenatoprazole was still present 5 days after treatment withdrawal especially during the night-time. The mean area under the plasma concentration-time curve and elimination half-time was significantly higher in the tenatoprazole group as compared with the esomeprazole group.CONCLUSION:Tenatoprazole 40 mg daily provides a prolonged duration of acid suppression and a shorter nocturnal acid breakthrough in healthy volunteers, even after stopping the drug. Thus, tenatoprazole may provide greater clinical efficacy for patients in whom a once daily PPI is ineffective. Further studies are indicated. |
Author | CHOWDHURY, Sadat K JAMES, Cindy HUNT, Richard H ARMSTRONG, David YUHONG YUAN |
Author_xml | – sequence: 1 givenname: Richard H surname: HUNT fullname: HUNT, Richard H organization: Division of Gastroenterology, McMaster University Medical Centre, Hamilton, Ontario, Canada – sequence: 2 givenname: David surname: ARMSTRONG fullname: ARMSTRONG, David organization: Division of Gastroenterology, McMaster University Medical Centre, Hamilton, Ontario, Canada – sequence: 3 givenname: Cindy surname: JAMES fullname: JAMES, Cindy organization: Division of Gastroenterology, McMaster University Medical Centre, Hamilton, Ontario, Canada – sequence: 4 givenname: Sadat K surname: CHOWDHURY fullname: CHOWDHURY, Sadat K organization: Division of Gastroenterology, McMaster University Medical Centre, Hamilton, Ontario, Canada – sequence: 5 surname: YUHONG YUAN fullname: YUHONG YUAN organization: Division of Gastroenterology, McMaster University Medical Centre, Hamilton, Ontario, Canada |
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Keywords | H Spirillaceae Male Antiulcer agent Tenatoprazole K Proton pump inhibitor Blood plasma Helicobacter pylori Antisecretory agent Gastroenterology pH Bacteria Half life Human Spirillales Healthy subject Enzyme Enzyme inhibitor Duration Benzimidazole derivatives Esomeprazole exchanging ATPase Hydrolases Comparative study |
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Snippet | To compare the inhibitory effect of a novel proton pump inhibitor (PPI), tenatoprazole 40 mg once daily, with esomeprazole 40 mg once daily on intragastric... OBJECTIVE:To compare the inhibitory effect of a novel proton pump inhibitor (PPI), tenatoprazole 40 mg once daily, with esomeprazole 40 mg once daily on... OBJECTIVETo compare the inhibitory effect of a novel proton pump inhibitor (PPI), tenatoprazole 40 mg once daily, with esomeprazole 40 mg once daily on... |
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SubjectTerms | 2-Pyridinylmethylsulfinylbenzimidazoles Adolescent Adult Anti-Ulcer Agents - administration & dosage Anti-Ulcer Agents - blood Anti-Ulcer Agents - pharmacokinetics Anti-Ulcer Agents - pharmacology Bacterial diseases Bacterial diseases of the digestive system and abdomen Biological and medical sciences Cross-Over Studies Esomeprazole - administration & dosage Esomeprazole - analogs & derivatives Esomeprazole - blood Esomeprazole - pharmacokinetics Esomeprazole - pharmacology Gastric Acidity Determination Gastroenterology Gastroenterology. Liver. Pancreas. Abdomen Half-Life Human bacterial diseases Humans Imidazoles - administration & dosage Imidazoles - blood Imidazoles - pharmacokinetics Imidazoles - pharmacology Infectious diseases Male Medical sciences Proton Pump Inhibitors Pyridines - administration & dosage Pyridines - blood Pyridines - pharmacokinetics Pyridines - pharmacology Stomach - drug effects |
Title | Effect on Intragastric pH of a PPI with a Prolonged Plasma Half-Life: Comparison between Tenatoprazole and Esomeprazole on the Duration of Acid Suppression in Healthy Male Volunteers |
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