Randomized controlled trial of standard versus high-dose intravenous omeprazole after endoscopic therapy in high-risk patients with acute peptic ulcer bleeding (original) (raw)
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Alimentary Pharmacology & Therapeutics, 2007
High-dose omeprazole reduces the rate of recurrent bleeding after endoscopic treatment of peptic ulcer bleeding. However, the effectiveness of high-dose vs. standard-dose omeprazole in peptic ulcer bleeding has never been shown. To compare the benefits of high-dose vs. standard-dose omeprazole in peptic ulcer bleeding. We reviewed the medical files of patients admitted between 1997 and 2004 for high-risk peptic ulcer bleeding who had undergone successful endoscopic treatment. We distinguished 2 periods: before 2001, standard-dose omeprazole (40 mg/day intravenously until alimentation was possible, then 40 mg/day orally for 1 week); after 2001, high-dose omeprazole (80 mg bolus injection, then 8 mg/h continuous infusion for 72 h, then 40 mg/day orally for 1 week). During both periods, patients subsequently received omeprazole, 20 mg/day, orally for 3 weeks. We enrolled 114 patients (period 1, n = 45, period 2, n = 69). Therapy with high-dose omeprazole significantly decreased the occurrence of poor outcome (27 vs. 12%, P = 0.04), rebleeding (24 vs. 7%, P = 0.01), mortality due to haemorrhagic shock (11 vs. 0%, P < 0.001) and need for surgery (9 vs. 1%, P = 0.05). In this retrospective study, high-dose omeprazole reduced the occurrence of rebleeding, need for surgery and mortality due to hemorrhagic shock in patients with high-risk peptic ulcer bleeding, as compared with standard-dose omeprazole.
Alimentary Pharmacology and Therapeutics, 2003
Background: Endoscopic therapies and continuous intravenous omeprazole can decrease the morbidity and duration of hospital stay of patients with high-risk peptic ulcer. Aim: To evaluate the role of oral omeprazole in highrisk bleeders. Methods: After injection therapy of 160 patients with high-risk peptic ulcer, 80 received oral omeprazole and 80 received placebo, and all were followed up. Results: One hundred and forty-nine patients (71 omeprazole and 78 placebo) completed the study. Eleven patients were excluded from the study. Thirtyseven (25%) patients had gastric ulcer and 112 (75%) had duodenal ulcer. Fifty-seven (38%) ulcers showed visible vessels, 80 (54%) showed oozing of blood and 12 (8%) showed a spurting artery. Only one patient died (placebo group). The mean hospital stays were 62.8 ± 28.6 h and 75 ± 39 h in the omeprazole and placebo groups, respectively (P ¼ 0.032). The mean amounts of blood transfused were 1.13 ± 1.36 and 1.68 ± 1.68 bags in the omeprazole and placebo groups, respectively (P ¼ 0.029). The re-bleeding rate was lower in the omeprazole group than in the placebo group (12 vs. 26, respectively; P ¼ 0.022). Conclusion: Oral omeprazole is effective in decreasing the hospital stay, re-bleeding rate and the need for blood transfusion in high-risk ulcer bleeders treated with endoscopic injection therapy.
Journal of Gastroenterology and Hepatology, 2006
Background and Aim: Following successful endoscopic therapy in patients with peptic ulcer bleeding, rebleeding occurs in 20% of patients. Rebleeding remains the most important determinant of poor prognosis. We investigated whether or not administration of pantoprazole infusion would improve the outcome in ulcer bleeding following successful endoscopic therapy.Methods: In this double-blind, placebo-controlled, prospective trial, patients who had gastric or duodenal ulcers with active bleeding or non-bleeding visible vessel received combined endoscopy therapy with injection of epinephrine and heater probe application. Patients who achieved hemostasis were randomly assigned to receive pantoprazole (80 mg intravenous bolus followed by an infusion at a rate of 8 mg per hour) or placebo for 72 h. The primary end-point was the rate of rebleeding.Results: Rebleeding was lower in the pantoprazole group (8 of 102 patients, 7.8%) than in the placebo group (20 of 101 patients, 19.8%; P = 0.01). Patients in the pantoprazole group required significantly fewer transfusions (1 ± 2.5 vs 2 ± 3.3; P = 0.003) and days of hospitalization (5.6 ± 5.3 vs 7.7 ± 7.3; P = 0.0003). Rescue therapies were needed more frequently in the placebo group (7.8% vs 19.8%; P = 0.01). Three (2.9%) patients in the pantoprazole group and eight (7.9%) in the placebo group required surgery to control their bleeding (P = 0.12). Two patients in the pantoprazole group and four in the placebo group died (P = 0.45).Conclusion: In patients with bleeding peptic ulcers, the use of high dose pantoprazole infusion following successful endoscopic therapy is effective in reducing rebleeding, transfusion requirements and hospital stay.
Endoscopic Dual Versus Monotherapy in Patients Bleeding from High-Risk Peptic Ulcers
Gastrointestinal Endoscopy, 2009
Aim: Dual endoscopic and pharmacologic therapy is currently the standard treatment for patients with high-risk peptic ulcer bleeding. The authors assess the efficacy of dual (endoscopic and pharmacologic) therapy versus endoscopic monotherapy in reducing rates of recurrent bleeding and death in patients with high-risk peptic bleeds. Methods: The authors carried out a post-hoc analysis of data on the use of intravenous proton pump inhibitors for the prevention of rebleeding ulcers and death (from an investigator-supported multicenter randomized trial in Italy). All the patients bleeding from high-risk peptic ulcers with a successful endoscopic hemostasis were treated with epinephrine injections alone (n = 157) or in combination with thermal therapy (n = 219). Results: Rebleeding occurred in 20 individuals (12.7%) in the monotherapy group, and in 21 individuals (9.6%) in the dual group (P = 0.33). Seven patients (4.5%) in the former group and 2 (0.9%) in the latter group died, with a 3.6% (95% CI: 0.3 to 8.1) absolute risk reduction. The mean number of units of blood transfused were 2.7 ± 1.7 and 3.2 ± 2.5 (P = 0.14), respectively, and the mean hospital stay was 6.7 ± 3.9 and 7.1 ± 4.3 days (P = 0.40), respectively. Multivariate analysis revealed that the sole independent predictor of death was ulcer size ≥ 20 mm [odds ratio (OR) = 6.56, 95% CI: 1.57 to 27.4]. Dual endoscopic and pharmacologic therapy provided a non-significant reduction in the risk of death (OR = 0.26, 95% CI: 0.05 to 1.34). Conclusion: When adjuvant proton pump inhibitors were administered, dual endoscopic and pharmacologic therapy was not superior to injection monotherapy for reducing rates of rebleeding and death.
The American Journal of Gastroenterology, 2014
The use of intravenous proton-pump inhibitors (PPI s) has shown to reduce recurrent bleeding and improve patient outcome after endoscopic hemostasis on patients with peptic ulcer. However, the effi cacy of oral PPI is uncertain. Studies from Asia indicated that even oral PPI can achieve the same therapeutic effect. This study is designed to compare the effi cacy of high-dose intravenous PPI to oral PPI in preventing recurrent bleeding after endoscopic hemostasis. METHODS: This is a single-center, randomized-controlled, double-blind, and double-dummy study. Patients had Forrest IA / IB or IIA / IIB peptic ulcer bleeding and received endoscopic hemostasis before recruitment into the study. They were randomized to receive either (i) esomeprazole IV bolus at a dose of 80 mg plus infusion at 8 mg / h for 72 h and oral placebo every 12 h (IVP group), or (ii) IV placebo bolus plus infusion for 72 h and high-dose oral esomeprazole at a dose of 40 mg every 12 h (ORP group). Patients were followed up for 30 days after index bleeding. The primary end point was defi ned as the 30-day recurrent bleeding after successful endoscopic hemostasis. RESULTS: A total of 118 patients were randomized to the IVP group and 126 to the ORP group in this study. In all, 39.8 % in the IVP and 42.9 % in the ORP group used non-steroidal anti-infl ammatory drug and / or aspirin before bleeding. In the IVP group (vs. ORP), Forrest IA represented 1.7 % (5.6 %), IB 41.5 % (38.1 %), IIA 52.5 % (50.8 %), and IIB 4.2 % (5.6 %). Recurrent bleeding in 30 days was reported in 7.7 % of patients in the IVP group and 6.4 % of patients in the ORP group, and the difference of recurrent bleeding was − 1.3 % (95 % CI: − 7.7 % , 5.1 %). There was no difference in blood transfusion, repeated endoscopic therapy, and hospital stay between the two groups. CONCLUSIONS: High-dose oral esomeprazole at 40 mg BID may be considered as a useful alternative to IV bolus plus infusion of esomeprazole in the management of ulcer bleeding in patients who are not candidates for high-dose IV infusion. However, as this study was stopped prematurely and was not designed as an equivalency trial, a much larger study would be necessary to document whether there is equivalency or non-inferiority of the two treatments in a heterogeneous patient population.