Research Express@NCKU - Articles Digest
Research Express@NCKU Volume 21 Issue 2 - January 6, 2012 [ http://research.ncku.edu.tw/re/articles/e/20120106/4.html ]
Seven-day Intravenous Low-dose Omeprazole Infusion Reduces Peptic Ulcer Rebleeding for Patients with Co- morbidities
Hsiu-Chi Cheng, MD
1,2, Wei-Lun Chang, MD
1,2, Yi-Chun Yeh, MS
1,3, Wei-Ying Chen, MD
1, Yu-Ching Tsai, MD
1,2, and Bor-Shyang Sheu, MD
1,2,*Departments Internal Medicine1, Institute of Clinical Medicine2, and Institute of Basic Medical Sciences3, Medical College, Tainan, Taiwan.
Gastointestinal Endoscopy 70, 433-9 (2009)
P
eptic ulcer bleeding is a common and potentially lethal condition. Re-bleeding is an independent risk factor of mortality, with risks that have been positively linked with the presence of co-morbidities. In contrast to those without co-morbidity, our previous study illustrated that patients with co-morbidities could experience recurrent bleeding from peptic ulcers as late as 4-14 days after the initial bleeding episode. Irrespective to the continuous infusion of omeprazole with either low-dose 3.3 mg/hr or high-dose 8 mg/hr within the first3 days following endoscopy, the cumulative peptic ulcer re-bleeding still remained high at nearly 30% during the 4th -28th days. Hence, this study aimed to determine whether a longer course of intravenous omeprazole infusion, which is more effective in maintaining favorable intra-gastric pH, could effectively reduce ulcer re-bleeding in patients with co-morbidities.
Intravenous proton pump infusion has confirmed with a positive impact on the prevention of re-bleeding peptic ulcer receiving endoscopic local therapy. Since the dosage of the 3-day high-dose omeprazole infusion could be reduced down from 8 mg/hr to 3.3 mg/hr, this study shifted the 3-day high-dose medication into a 7-day low-dose medication with the same drug cost of omeprazole infusion. In this study, we introduced a favorable approach with a prolonged low-dose omeprazole infusion to obtain a near zero rebleeding during the 8th -28th days after the first bleeding episode. This data shows the originality and clinical importance of a prolonged duration of
omeprazole infusion for such high risky co-morbid patients with peptic ulcer bleeding.
From April 2004 to April 2008, 147 patients with one or more co-morbidities, undergoing upper gastroscopy due to peptic ulcer bleeding with stigmata of recent hemorrhage (SRH), and proven to have good hemostasis by endoscopic therapy, were consecutively enrolled in this study after obtaining informed consent,. The SRH was defined as either major or minor in type in our previous report. All of the major SRH were treated by endoscopic hemostasis to eradicate the vessel.
Each enrolled patient received 80 mg loading of intravenous omeprazole (Losec®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis by endoscopic therapy. Each patient was then randomized by chart-code into either a low-dose (7-day continuous omeprazole infusion at 3.3 mg/hr) or a high-dose (3-day continuous omeprazole infusion at 8 mg/hr) group. Patients with Helicobacter pylori (H. pylori) infection, were treated with a 7-day course triple therapy that included 500 mg clarithromycin, 1 g amoxicillin, and 40 mg esomeprazole twice daily after the cessation of omeprazole infusion. After omeprazole infusion (some after 7-day triple therapy), oral esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) 40 mg qd was given until the end of 28 days after
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Research Express@NCKU - Articles Digest
panendoscopy and the primary end-point was re-bleeding within the 28-day study period.
Excluding 5 of 147 patients (two with gastric cancer bleeding, one with pancreatic cancer with duodenal invasion, and two with variceal bleeding, the remaining 142 patients were randomized into either a 7-day low-dose group (n=66) or a 3-day high-dose group (n=76) by the chart code. There were 3 patients died due to the recurrence of re- bleeding in each group. On enrollment, the demographic background, ulcer characteristics and the clinical features possibly related with re-bleeding were not significantly different between the two groups.
Different duration of omeprazole infusion and re-bleeding rates
The 7-day cumulative re-bleeding rate was similar between the 7-day low-dose and the 3-day high-dose groups (per-protocol: 9.5% [6/63] vs. 9.7% [7/72], p>0.05; intention-to-treat: 9.1% [6/66] vs. 9.2% [7/76], p>0.05).
However, between the 8th to the 28th day, there were significantly lower re-bleeding rates in the 7-day low-dose group than in the 3-day high-dose group based on per-protocol analysis (0% [0/46] vs. 10.7% [6/56], p=0.02;
relative risk [95%]: 0.52 [0.43, 0.63]).
Conclusions:
Prolonged low-dose omeprazole infusion for 7 days may reduce peptic ulcer re-bleeding during the first 28 days in patients with co-morbidities in Asians.
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