Tenatoprazole, a novel proton pump inhibitor with a prolonged plasma half-life: effects on intragastric pH and comparison with esomeprazole in healthy volunteers.

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.