High- versus low-dose proton pump inhibitors after endoscopic hemostasis in patients with peptic ulcer bleeding: a multicentre, randomized study.
BACKGROUND
The most effective schedule of proton pump inhibitor (PPI) administration following endoscopic hemostasis of bleeding ulcers remains uncertain.


METHODS
Patients with actively bleeding ulcers and those with nonbleeding visible vessel or adherent clot were treated with epinephrine injection and/or thermal coagulation, and randomized to receive intravenous PPIs according to an intensive regimen (80 mg bolus followed by 8 mg/h as continuous infusion for 72 h) or a standard regimen (40 mg bolus daily followed by saline infusion for 72 h). After the infusion, all patients were given 20 mg PPI twice daily orally. The primary end point was the in-hospital rebleeding rate, as ascertained at the repeat endoscopy.


RESULTS
Bleeding recurred in 28 of 238 patients (11.8%) receiving the intensive regimen, and in 19 of 236 (8.1%) patients receiving the standard regimen (P= 0.18). Most rebleeding episodes occurred during the initial 72-h infusion: 18 (7.6%) and 19 events (8.1%) in the intensive and standard groups, respectively (P= 0.32). Mean units of blood transfused were 1.7 +/- 2.1 in the intensive and 1.5 +/- 2.1 in the standard regimen group (P= 0.34). The duration of hospital stay was <5 days for 88 (37.0%) and 111 patients (47.0%) in the intensive and standard groups (P= 0.03). There were fewer surgical interventions in the standard versus intensive regimen (1 vs 3). Five patients in each treatment group died.


CONCLUSIONS
Following endoscopic hemostasis of bleeding ulcers, standard-dose PPIs infusion was as effective as a high-dose regimen in reducing the risk of recurrent bleeding. (ClinicalTrials.gov number, NCT00374101).
Andriulli
Angelo
A
Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni, Rotondo, Italy.
Loperfido
Silvano
S
Focareta
Rosaria
R
Leo
Pietro
P
Fornari
Fabio
F
Garripoli
Antonietta
A
Tonti
Paolo
P
Peyre
Sergio
S
Spadaccini
Antonio
A
Marmo
Riccardo
R
Merla
Antonio
A
Caroli
Alessandro
A
Forte
Gian Battista
GB
Belmonte
Angelo
A
Aragona
Giovanni
G
Imperiali
Gianni
G
Forte
Fabrizio
F
Monica
Fabio
F
Caruso
Nazario
N
Perri
Francesco
F
D000368:Aged; D004311:Double-Blind Method; D005260:Female; D016558:Hemostasis, Endoscopic; D006801:Humans; D008297:Male; D008875:Middle Aged; D010438:Peptic Ulcer Hemorrhage / Q000628:therapy*; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D012008:Recurrence
D054328:Proton Pump Inhibitors