BACKGROUND:Patients with comorbidities have an increased risk of ulcer rebleeding, especially within the 28 days after endoscopic therapy. Omeprazole infusion can prevent rebleeding after endoscopic therapy in patients with peptic ulcer bleeding. However, the optimal duration is uncertain, especially for those patients with comorbidities. OBJECTIVE: To determine whether prolonged low-dose intravenous omeprazole could reduce rebleeding for patients with comorbidities. DESIGN: A prospective randomized control study. SETTING: National Cheng Kung University, Tainan, Taiwan. PATIENTS: A total of 147 patients with comorbidities and peptic ulcer bleeding controlled by endoscopic hemostasis were enrolled. INTERVENTIONS: The enrolled patients were randomized into either the 7-day low-dose group or the 3-day high-dose group, who received 3.3 mg/h or 8 mg/h continuous omeprazole infusion, respectively. After omeprazole infusion, oral esomeprazole 40 mg every day was given. MAIN OUTCOME MEASUREMENTS: To compare the rebleeding rates within 28 days after gastroscopy between the 2 study groups. RESULTS: The 7-day cumulative rebleeding rate was similar between the 2 groups (9.5% vs 9.7%, P > .05), but the 7-day low-dose group had a lower risk of rebleeding between the 8th and 28th day compared with the 3-day high-dose group (0% vs 10.7%, P = .03; relative risk, 0.52 [95% CI, 0.43-0.63]). The Kaplan-Meier curves confirmed that the 7-day low-dose group had a significantly higher cumulative rebleeding-free proportion between the 8th and 28th day than the 3-day high-dose group (P = .02, log-rank test). CONCLUSIONS: In Asian patients, prolonged low-dose omeprazole infusion for 7 days may reduce peptic ulcer rebleeding during the first 28 days in patients with comorbidities.
RCT Entities:
BACKGROUND:Patients with comorbidities have an increased risk of ulcer rebleeding, especially within the 28 days after endoscopic therapy. Omeprazole infusion can prevent rebleeding after endoscopic therapy in patients with peptic ulcer bleeding. However, the optimal duration is uncertain, especially for those patients with comorbidities. OBJECTIVE: To determine whether prolonged low-dose intravenous omeprazole could reduce rebleeding for patients with comorbidities. DESIGN: A prospective randomized control study. SETTING: National Cheng Kung University, Tainan, Taiwan. PATIENTS: A total of 147 patients with comorbidities and peptic ulcer bleeding controlled by endoscopic hemostasis were enrolled. INTERVENTIONS: The enrolled patients were randomized into either the 7-day low-dose group or the 3-day high-dose group, who received 3.3 mg/h or 8 mg/h continuous omeprazole infusion, respectively. After omeprazole infusion, oral esomeprazole 40 mg every day was given. MAIN OUTCOME MEASUREMENTS: To compare the rebleeding rates within 28 days after gastroscopy between the 2 study groups. RESULTS: The 7-day cumulative rebleeding rate was similar between the 2 groups (9.5% vs 9.7%, P > .05), but the 7-day low-dose group had a lower risk of rebleeding between the 8th and 28th day compared with the 3-day high-dose group (0% vs 10.7%, P = .03; relative risk, 0.52 [95% CI, 0.43-0.63]). The Kaplan-Meier curves confirmed that the 7-day low-dose group had a significantly higher cumulative rebleeding-free proportion between the 8th and 28th day than the 3-day high-dose group (P = .02, log-rank test). CONCLUSIONS: In Asian patients, prolonged low-dose omeprazole infusion for 7 days may reduce peptic ulcer rebleeding during the first 28 days in patients with comorbidities.