High- Versus Low-Dose PPI in Patients With Peptic Ulcer Bleeding
High- Versus Low-Dose PPI in Patients With Peptic Ulcer Bleeding
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).
For patients with bleeding peptic ulcers that display major endoscopic stigmata of recent hemorrhage, a combination of endoscopic and pharmacologic therapy is the current standard management; however, the optimal regimen for administration of proton pump inhibitors (PPIs) remains controversial. Two consensus documents have endorsed a high-dose PPI regimen (80 mg stat followed by an infusion of 8 mg/h for 72 h). The biologically plausible mechanism of benefit of such a high-dose regimen is to promote clot stability by sustaining the intragastric pH above 6. Once primary hemostasis is achieved by endoscopic therapy, clinical trials show that a high-dose PPI infusion is superior to placebo; however, when the comparator is a standard-dose PPI regimen, four prospective trials and a meta-analysis report no difference in the magnitude of risk reduction between the intensive- and the low-dose regimens.
We conducted a head-to-head study, comparing two strategies for intravenous PPI administration in the prevention of rebleeding, surgery, and death in patients with high-risk bleeding peptic ulcers in whom successful endoscopic hemostasis was achieved.
Abstract and Introduction
Abstract
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).
Introduction
For patients with bleeding peptic ulcers that display major endoscopic stigmata of recent hemorrhage, a combination of endoscopic and pharmacologic therapy is the current standard management; however, the optimal regimen for administration of proton pump inhibitors (PPIs) remains controversial. Two consensus documents have endorsed a high-dose PPI regimen (80 mg stat followed by an infusion of 8 mg/h for 72 h). The biologically plausible mechanism of benefit of such a high-dose regimen is to promote clot stability by sustaining the intragastric pH above 6. Once primary hemostasis is achieved by endoscopic therapy, clinical trials show that a high-dose PPI infusion is superior to placebo; however, when the comparator is a standard-dose PPI regimen, four prospective trials and a meta-analysis report no difference in the magnitude of risk reduction between the intensive- and the low-dose regimens.
We conducted a head-to-head study, comparing two strategies for intravenous PPI administration in the prevention of rebleeding, surgery, and death in patients with high-risk bleeding peptic ulcers in whom successful endoscopic hemostasis was achieved.
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