Oral buffered esomeprazole is superior to i.v. pantoprazole for rapid rise of intragastric pH: a wireless pH metry analysis.
OBJECTIVE
A pH of more than 6 is required for clot stability and hemostasis. Intravenous proton pump inhibitors have a rapid onset of action compared to oral and have been preferred for management of non-variceal bleeding. Intravenous pantoprazole has been used extensively. Buffered esomeprazole (BE) is an oral preparation consisting of an inner core of non-enteric-coated esomeprazole with a shell of sodium bicarbonate. The buffer protects against acid degradation of esomeprazole in addition to immediate antacid action. The aim of this study was to assess the efficacy of BE for raising and maintaining an intragastric pH of more than 6 in comparison to i.v. pantoprazole in equivalent dosing.


METHODS
A randomized two-way cross-over study was conducted. Ten healthy volunteers were randomized to twice daily BE 40 mg or pantoprazole 40 mg i.v. bolus. Intragastric pH was measured with a wireless pH radiotelemetry capsule (Bravo, Medtronic). A 2-week washout period was given between doses.


RESULTS
BE achieved a steady pH of more than 6 in a median time of 2 min (range 1-5 min) after the first dose. The mean % time that intragastric pH was more than 6.0 for BE was 96%, and 90% of the 24-h period compared to pantoprazole (47% and 18%), P = 0.000. A median pH (interquartile range) for the BE group was 6.2 (6.175-6.2) which was higher than i.v. pantoprazole 4.60 (4.5-5.0) (P = 0.005).


CONCLUSIONS
BE achieves and maintains a pH of more than 6 within minutes of administration. It was significantly superior to i.v. pantoprazole in equivalent dosing. This finding could have implications in the management of non-variceal bleed where a rapid and sustained pH of more than 6 is desirable.
Banerjee
Rupa
R
Asian Institute of Gastroenterology, Somajiguda, Hyderabad, India.
Reddy
D Nageshwar
DN
Guda
Nalini M
NM
Kalpala
Rakesh
R
Mahurkar
Swapna
S
Darisetty
Santosh
S
Rao
G Venkat
GV
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage*; D000284:Administration, Oral; D000328:Adult; D002021:Buffers; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D015536:Down-Regulation; D064098:Esomeprazole / Q000008:administration & dosage* / Q000737:chemistry; D005260:Female; D005744:Gastric Acid / Q000378:metabolism*; D005745:Gastric Acidity Determination; D005753:Gastric Mucosa / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007275:Injections, Intravenous; D008297:Male; D000077402:Pantoprazole; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000737:chemistry; D017693:Sodium Bicarbonate / Q000737:chemistry; D013686:Telemetry; D013997:Time Factors; D055815:Young Adult
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D002021:Buffers; D054328:Proton Pump Inhibitors; D017693:Sodium Bicarbonate; D000077402:Pantoprazole; D064098:Esomeprazole