A comparative study of the early effects of tenatoprazole 40 mg and esomeprazole 40 mg on intragastric pH in healthy volunteers.
BACKGROUND
Tenatoprazole is a novel proton pump inhibitor with a seven-hour plasma half-life.


OBJECTIVE
To compare the effects of tenatoprazole 40 mg and esomeprazole 40 mg on intragastric acidity during the first 48 h in healthy volunteers.


METHODS
This randomized two-period crossover study included 24 Helicobacter Pylori-negative subjects; tenatoprazole 40 mg or esomeprazole 40 mg daily were given before breakfast for two consecutive days, with a 2-week wash-out between the administration periods. Intragastric pH was monitored for 48 h.


RESULTS
Over 48 h, tenatoprazole 40 mg exerted a more potent acid inhibition than esomeprazole 40 mg (median pH: 4.3 vs. 3.9, P < 0.08; per cent of time above pH 4: 57% vs. 49%, P < 0.03; proportion of subjects with at least half of the time above pH 4: 71% vs. 46%). These differences resulted from better night-time acid control with tenatoprazole 40 mg than esomeprazole 40 mg (first night median pH: 4.2 vs. 2.9, P < 0.0001; second night: 4.5 vs. 3.2, P < 0.0001). The duration of nocturnal acid breakthroughs was significantly reduced during both nights. In contrast, no significant difference was detected during the daytime periods between both regimens.


CONCLUSIONS
Over the first 48 h, tenatoprazole 40 mg achieves a better overall and night-time control of gastric pH than esomeprazole 40 mg. The translation of better early control of acidity into clinical benefits deserves further studies.
Galmiche
J P
JP
CIC-INSERM-CHU de Nantes, France. jeanpaul.galmiche@chu-nantes.fr
Sacher-Huvelin
S
S
Bruley des Varannes
S
S
Vavasseur
F
F
Taccoen
A
A
Fiorentini
P
P
Homerin
M
M
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D018592:Cross-Over Studies; D064098:Esomeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology*; D005744:Gastric Acid / Q000378:metabolism*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007093:Imidazoles / Q000008:administration & dosage / Q000494:pharmacology*; D008297:Male; D054328:Proton Pump Inhibitors; D011725:Pyridines / Q000008:administration & dosage / Q000494:pharmacology*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D007093:Imidazoles; D054328:Proton Pump Inhibitors; D011725:Pyridines; D064098:Esomeprazole; C119998:Tenatoprazole