Cost-Effectiveness of Proton-Pump Inhibition Before Endoscopy in Upper Gastrointestinal Bleeding
2008; Elsevier BV; Volume: 6; Issue: 4 Linguagem: Inglês
10.1016/j.cgh.2007.12.037
ISSN1542-7714
AutoresSalman Al‐Sabah, Alan Barkun, Karl Herba, Viviane Adam, Carlo A Fallone, Serge Mayrand, Gilles Pomier–Layrargues, Wendy Kennedy, Marc Bardou,
Tópico(s)Gastrointestinal disorders and treatments
ResumoBackground & Aims: Randomized trials suggest high-dose proton-pump inhibitors (PPIs) administered before gastroscopy in suspected upper gastrointestinal bleeding downstage bleeding ulcer stigmata. We assessed the cost-effectiveness of this approach. Methods: A decision model compared high-dose IVPPI initiated while awaiting endoscopy with IVPPI administration on the basis of endoscopic findings. IVPPIs were given to all patients undergoing endoscopic hemostasis for 72 hours thereafter. Once the IV regimen was completed or for patients with low-risk endoscopic lesions, an oral daily PPI was given for the remainder of the time horizon (30 days after endoscopy). The unit of effectiveness was the proportion of patients without rebleeding, representing the denominator of the cost-effectiveness ratio (cost per no rebleeding). Probabilities and costs were derived from the literature and national databases. Results: IVPPIs before endoscopy were both slightly more costly and effective than after gastroscopy in the U.S. and Canadian settings, with cost-effectiveness ratios of US$5048 versus $4933 and CAN$6064 versus $6025 and incremental costs of US$45,673 and CAN$19,832 to prevent one additional rebleeding episode, respectively. Sensitivity analyses showed robust results in the US In Canada, intravenous proton-pump inhibitors (IVPPIs) before endoscopy became more effective and less costly (dominant strategy) when the uncomplicated stay for high-risk patients increased above 6 days or that of low-risk patients decreased below 3 days. Conclusions: With conservative estimates and high-quality data, IVPPIs given before endoscopy are slightly more effective and costly than no administration. In Canada, this approach becomes dominant as the duration of hospitalization for high-risk ulcer patients increases or that of low-risk ulcer patients decreases. Background & Aims: Randomized trials suggest high-dose proton-pump inhibitors (PPIs) administered before gastroscopy in suspected upper gastrointestinal bleeding downstage bleeding ulcer stigmata. We assessed the cost-effectiveness of this approach. Methods: A decision model compared high-dose IVPPI initiated while awaiting endoscopy with IVPPI administration on the basis of endoscopic findings. IVPPIs were given to all patients undergoing endoscopic hemostasis for 72 hours thereafter. Once the IV regimen was completed or for patients with low-risk endoscopic lesions, an oral daily PPI was given for the remainder of the time horizon (30 days after endoscopy). The unit of effectiveness was the proportion of patients without rebleeding, representing the denominator of the cost-effectiveness ratio (cost per no rebleeding). Probabilities and costs were derived from the literature and national databases. Results: IVPPIs before endoscopy were both slightly more costly and effective than after gastroscopy in the U.S. and Canadian settings, with cost-effectiveness ratios of US$5048 versus $4933 and CAN$6064 versus $6025 and incremental costs of US$45,673 and CAN$19,832 to prevent one additional rebleeding episode, respectively. Sensitivity analyses showed robust results in the US In Canada, intravenous proton-pump inhibitors (IVPPIs) before endoscopy became more effective and less costly (dominant strategy) when the uncomplicated stay for high-risk patients increased above 6 days or that of low-risk patients decreased below 3 days. Conclusions: With conservative estimates and high-quality data, IVPPIs given before endoscopy are slightly more effective and costly than no administration. In Canada, this approach becomes dominant as the duration of hospitalization for high-risk ulcer patients increases or that of low-risk ulcer patients decreases. Upper gastrointestinal bleeding (UGIB) is a common condition with an estimated cost of US$750 million.1Longstreth G.F. Feitelberg S.P. Outpatient care of selected patients with acute non-variceal upper gastrointestinal haemorrhage.Lancet. 1995; 345: 108-111Abstract PubMed Google Scholar, 2Adam V. Barkun A.N. Estimates of costs of hospital stay for variceal and non-variceal ulcer gastrointestinal bleeding in United States.Value in Health. 2008; 11 (:(in press).)Google Scholar High-dose IV proton-pump inhibition (PPI) in patients having initially undergone endoscopic hemostasis results in improvements in outcomes,3Bardou M. Toubouti Y. Benhaberou-Brun D. et al.Meta-analysis: proton-pump inhibition in high-risk patients with acute peptic ulcer bleeding.Aliment Pharmacol Ther. 2005; 21: 677-686Crossref PubMed Scopus (119) Google Scholar, 4Leontiadis G.I. Sharma V.K. Howden C.W. Proton pump inhibitor treatment for acute peptic ulcer bleeding.Cochrane Database Syst Rev. 2006; (CD002094)Google Scholar while being cost-saving.5Barkun A.N. Herba K. Adam V. et al.High-dose intravenous proton pump inhibition following endoscopic therapy in the acute management of patients with bleeding peptic ulcers in the USA and Canada: a cost-effectiveness analysis.Aliment Pharmacol Ther. 2004; 19: 591-600Crossref PubMed Scopus (75) Google Scholar, 6Spiegel B.M. Ofman J.J. Woods K. et al.Minimizing recurrent peptic ulcer hemorrhage after endoscopic hemostasis: the cost-effectiveness of competing strategies.Am J Gastroenterol. 2003; 98: 86-97Crossref PubMed Scopus (86) Google Scholar In contrast, the administration of high-dose intravenous proton-pump inhibitors (IVPPI) before endoscopy has remained controversial,7Barkun A. Bardou M. Marshall J.K. Consensus recommendations for managing patients with nonvariceal upper gastrointestinal bleeding.Ann Intern Med. 2003; 139: 843-857Crossref PubMed Scopus (497) Google Scholar and exploratory cost-effectiveness analyses8Enns R.A. Gagnon Y.M. Rioux K.P. et al.Cost-effectiveness in Canada of intravenous proton pump inhibitors for all patients presenting with acute upper gastrointestinal bleeding.Aliment Pharmacol Ther. 2003; 17: 225-233Crossref PubMed Scopus (55) Google Scholar, 9Gagnon Y.M. Levy A.R. Eloubeidi M.A. et al.Cost implications of administering intravenous proton pump inhibitors to all patients presenting to the emergency department with peptic ulcer bleeding.Value Health. 2003; 6: 457-465Abstract Full Text PDF PubMed Scopus (33) Google Scholar did not benefit from recent individual10Lau J.Y. Leung W.K. Wu J.C. et al.Omeprazole before endoscopy in patients with gastrointestinal bleeding.N Engl J Med. 2007; 356: 1631-1640Crossref PubMed Scopus (252) Google Scholar and summary clinical data.11Dorward S. Sreedharan A. Leontiadis G.I. et al.Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.Cochrane Database Syst Rev. 2006; 18 (CD005415.)Google Scholar The present cost-effective analysis studied the role of high-dose IVPPI administration before endoscopy in patients with suspected UGIB on the basis of contemporary clinical trial data. Any benefit of the IVPPI is assumed to be a class effect,10Lau J.Y. Leung W.K. Wu J.C. et al.Omeprazole before endoscopy in patients with gastrointestinal bleeding.N Engl J Med. 2007; 356: 1631-1640Crossref PubMed Scopus (252) Google Scholar, 11Dorward S. Sreedharan A. Leontiadis G.I. et al.Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.Cochrane Database Syst Rev. 2006; 18 (CD005415.)Google Scholar, 12Barkun A.N. Cockeram A.W. Plourde V. et al.Review article: acid suppression in non-variceal acute upper gastrointestinal bleeding.Aliment Pharmacol Ther. 1999; 13: 1565-1584Crossref PubMed Scopus (98) Google Scholar and we have thus not intended to support the use of one IVPPI over another. Because of existing variability in health care resource utilization and costs, we assessed both American and Canadian health care settings separately. We constructed a decision tree model with the TreeAge Pro Suite Healthcare module 2005 (TreeAge Software Inc, Williamstown, MA) for patients with a suspected episode of acute UGIB, comparing 2 managements: In one, high-dose IVPPI (pantoprazole 80-mg bolus followed by 8 mg hourly) was started while awaiting an initial endoscopy for bleeding; the wait time until endoscopy was modeled to be 24 hours on the basis of existing data.10Lau J.Y. Leung W.K. Wu J.C. et al.Omeprazole before endoscopy in patients with gastrointestinal bleeding.N Engl J Med. 2007; 356: 1631-1640Crossref PubMed Scopus (252) Google Scholar, 11Dorward S. Sreedharan A. Leontiadis G.I. et al.Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.Cochrane Database Syst Rev. 2006; 18 (CD005415.)Google Scholar, 13Daneshmend T.K. Hawkey C.J. Langman M.J. et al.Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial.BMJ. 1992; 304: 143-147Crossref PubMed Scopus (216) Google Scholar, 14Hawkey G.M. Cole A.T. McIntyre A.S. et al.Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points.Gut. 2001; 49: 372-379Crossref PubMed Scopus (51) Google Scholar, 15Wallner G. Ciechanski A. Wesolowski M. et al.Treatment of acute upper gastrointestinal bleeding with intravenous omeprazole or ranitidine.Eur J Clin Res. 1996; 8: 235-243Google Scholar In the second, the same IVPPI regimen was started only after endoscopy. For both, the infusion was continued for 72 hours after the gastroscopy only in patients receiving endoscopic hemostasis for a lesion at high risk for rebleeding16Lin H.J. Lo W.C. Lee F.Y. et al.A prospective randomized comparative trial showing that omeprazole prevents rebleeding in patients with bleeding peptic ulcer after successful endoscopic therapy.Arch Intern Med. 1998; 158: 54-58Crossref PubMed Scopus (240) Google Scholar followed by a daily oral dose of pantoprazole 40 mg until the end of the time horizon (30 days after endoscopy). All other patients received the daily oral dose after endoscopy. Patients who failed initial endoscopic hemostasis were referred for surgery. The model structure (Figure 1) was based on published trials and validated by expert clinicians (A.B., C.F.). The first strategy was referred to as the pre-endoscopy IVPPI and the second as the post-endoscopy IVPPI. Patients were stratified into those bleeding from gastroduodenal ulcers, esophageal varices, or other causes (Table 1). Patients with ulcer bleeding were further categorized into high, low, and very low risk groups. The possibility of rebleeding with its consequences was modeled. Patients who died were excluded from the analysis. Our 30-day time horizon is a commonly reported length of follow-up in UGIB trials.7Barkun A. Bardou M. Marshall J.K. Consensus recommendations for managing patients with nonvariceal upper gastrointestinal bleeding.Ann Intern Med. 2003; 139: 843-857Crossref PubMed Scopus (497) Google ScholarTable 1Probability Estimates and Range AssumptionsPoint estimateRange for sensitivity analysisSourceBase-case scenarioaAccording to values published in Cochrane meta-analysis.11Alternate scenariobAccording to values published in study by Lau et al.10Low valueHigh valueIVPPI started before endoscopy: Proportion of high-risk patients among all U patients0.370.220.330.4111Dorward S. Sreedharan A. Leontiadis G.I. et al.Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.Cochrane Database Syst Rev. 2006; 18 (CD005415.)Google Scholar Proportion of low-risk patients among all U patients0.370.520.160.40cThis is a calculated variable whose value is determined by the chosen estimates for the proportion of low-risk and proportion of very low-risk patients among all U patients. Proportion of very low-risk patients among all U patients0.250.250.160.4720Lai K.C. Hui W.M. Wong B.C. et al.A retrospective and prospective study on the safety of discharging selected patients with duodenal ulcer bleeding on the same day as endoscopy.Gastrointest Endosc. 1997; 45: 26-30Abstract Full Text Full Text PDF PubMed Scopus (84) Google ScholarIVPPI started after endoscopy: Proportion of high-risk patients among all U patients0.460.370.420.5111Dorward S. Sreedharan A. Leontiadis G.I. et al.Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.Cochrane Database Syst Rev. 2006; 18 (CD005415.)Google Scholar Proportion of low-risk patients among all U patients0.280.380.060.37cThis is a calculated variable whose value is determined by the chosen estimates for the proportion of low-risk and proportion of very low-risk patients among all U patients. Proportion of very low-risk patients among all U patients0.250.250.160.4720Lai K.C. Hui W.M. Wong B.C. et al.A retrospective and prospective study on the safety of discharging selected patients with duodenal ulcer bleeding on the same day as endoscopy.Gastrointest Endosc. 1997; 45: 26-30Abstract Full Text Full Text PDF PubMed Scopus (84) Google ScholarFor both strategies (IVPPI after and before endoscopy): Proportion of NVNU patients among all UGIB patients0.430.4140.4530Crook J.N. Gray L.W.J. Nance F.C. et al.Upper gastrointestinal bleeding.Ann Surg. 1972; 175: 771-782Crossref PubMed Scopus (38) Google Scholar Proportion of V patients among all UGIB patients0.100.090.12dThis is a calculated variable whose value is determined by the chosen estimates for the proportion of NVNU patients and the proportion of U patients among all the UGIB patients. Proportion of U patients among all UGIB patients0.4640.450.4829Silverstein F.E. Gilbert D.A. Tedesco F.J. et al.The national ASGE survey on upper gastrointestinal bleeding II. Clinical prognostic factors.Gastrointest Endosc. 1981; 27: 80-93Abstract Full Text PDF PubMed Scopus (327) Google Scholar, 30Crook J.N. Gray L.W.J. Nance F.C. et al.Upper gastrointestinal bleeding.Ann Surg. 1972; 175: 771-782Crossref PubMed Scopus (38) Google Scholar Probability of rebleeding for U patients with high-risk stigmata0.110.020.1111Dorward S. Sreedharan A. Leontiadis G.I. et al.Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.Cochrane Database Syst Rev. 2006; 18 (CD005415.)Google ScholarProbability: Of rebleeding for U patients with low-risk stigmata0.070.050.0819Laine L. Peterson W.L. Bleeding peptic ulcer.N Engl J Med. 1994; 331: 717-727Crossref PubMed Scopus (666) Google Scholar, 39Branicki F.J. Coleman S.Y. Fok P.J. et al.Bleeding peptic ulcer: a prospective evaluation of risk factors for rebleeding and mortality.World J Surg. 1990; 14: 262-269Crossref PubMed Scopus (135) Google Scholar, 40Jensen D.M. New developments in the diagnosis and treatment of severe upper GI bleeding.in: Tytgat G.N. Van Blankenstein M. Current topics in gastroenterology and hepatology. Georg Thieme Verlag, Stuttgart, Germany1990: 4-22Google Scholar, 41Matthewson K. Swain C.P. 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Wong B.C. et al.A retrospective and prospective study on the safety of discharging selected patients with duodenal ulcer bleeding on the same day as endoscopy.Gastrointest Endosc. 1997; 45: 26-30Abstract Full Text Full Text PDF PubMed Scopus (84) Google Scholar That the endoscopy failed for U patients with high-risk stigmata0.020.010.0318Lau J.Y. Sung J.J. Lee K.K. et al.Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers.N Engl J Med. 2000; 343: 310-316Crossref PubMed Scopus (602) Google Scholar, 55Chung S.S. Lau J.Y. Sung J.J. et al.Randomised comparison between adrenaline injection alone and adrenaline injection plus heat probe treatment for actively bleeding ulcers.BMJ. 1997; 314: 1307-1311Crossref PubMed Scopus (198) Google Scholar, 56Laine L. Multipolar electrocoagulation in the treatment of active upper gastrointestinal tract hemorrhage: a prospective controlled trial.N Engl J Med. 1987; 316: 1613-1617Crossref PubMed Scopus (215) Google Scholar, 57Laine L. Multipolar electrocoagulation versus injection therapy in the treatment of bleeding peptic ulcers: a prospective, randomized trial.Gastroenterology. 1990; 99: 1303-1306PubMed Google Scholar, 58Lau J.Y. Sung J.J. Lam Y.H. et al.Endoscopic retreatment compared with surgery in patients with recurrent bleeding after initial endoscopic control of bleeding ulcers.N Engl J Med. 1999; 340: 751-756Crossref PubMed Scopus (340) Google Scholar, 59Villanueva C. Balanzo J. Torras X. et al.Omeprazole versus ranitidine as adjunct therapy to endoscopic injection in actively bleeding ulcers: a prospective and randomized study.Endoscopy. 1995; 27: 308-312Crossref PubMed Scopus (88) Google ScholarLOS With rebleeding for NVNU patients in Canada7.2312.828Barkun A. Sabbah S. Enns R. et al.The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting.Am J Gastroenterol. 2004; 99: 1238-1246Crossref PubMed Scopus (312) Google Scholar With rebleeding for NVNU patients in the U.S.4.41860Nationwide Inpatient Sample (NIS)http://www.hcup-us.ahrq.gov/nisoverview.jspGoogle Scholar Without rebleeding for NVNU patients in Canada5.421128Barkun A. Sabbah S. Enns R. et al.The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting.Am J Gastroenterol. 2004; 99: 1238-1246Crossref PubMed Scopus (312) Google Scholar Without rebleeding for NVNU patients in the U.S.2.714.660Nationwide Inpatient Sample (NIS)http://www.hcup-us.ahrq.gov/nisoverview.jspGoogle Scholar With rebleeding in U patients with high-risk stigmata in Canada10.8320.328Barkun A. Sabbah S. Enns R. et al.The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting.Am J Gastroenterol. 2004; 99: 1238-1246Crossref PubMed Scopus (312) Google Scholar With rebleeding in U patients with high-risk stigmata in the U.S.4.43860Nationwide Inpatient Sample (NIS)http://www.hcup-us.ahrq.gov/nisoverview.jspGoogle Scholar Without rebleeding in U patients with high-risk stigmata in Canada4.738.528Barkun A. Sabbah S. Enns R. et al.The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting.Am J Gastroenterol. 2004; 99: 1238-1246Crossref PubMed Scopus (312) Google Scholar Without rebleeding in U patients with high-risk stigmata in the U.S.2.724.660Nationwide Inpatient Sample (NIS)http://www.hcup-us.ahrq.gov/nisoverview.jspGoogle Scholar With rebleeding in U patients with low-risk stigmata in Canada10.8220.328Barkun A. Sabbah S. Enns R. et al.The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting.Am J Gastroenterol. 2004; 99: 1238-1246Crossref PubMed Scopus (312) Google Scholar With rebleeding in U patients with low-risk stigmata in the U.S.4.42860Nationwide Inpatient Sample (NIS)http://www.hcup-us.ahrq.gov/nisoverview.jspGoogle Scholar Without rebleeding in U patients with low-risk stigmata in Canada4.728.528Barkun A. Sabbah S. Enns R. et al.The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting.Am J Gastroenterol. 2004; 99: 1238-1246Crossref PubMed Scopus (312) Google Scholar Without rebleeding in U patients with low-risk stigmata in the U.S.2.724.660Nationwide Inpatient Sample (NIS)http://www.hcup-us.ahrq.gov/nisoverview.jspGoogle Scholar With rebleeding in V patients in Canada29.3261.128Barkun A. Sabbah S. Enns R. et al.The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting.Am J Gastroenterol. 2004; 99: 1238-1246Crossref PubMed Scopus (312) Google Scholar With rebleeding in V patients in the U.S.15.29.720.760Nationwide Inpatient Sample (NIS)http://www.hcup-us.ahrq.gov/nisoverview.jspGoogle Scholar Without rebleeding in V patients in Canada9.73.815.628Barkun A. Sabbah S. Enns R. et al.The Canadian Registry on Nonvariceal Upper Gastrointestinal Bleeding and Endoscopy (RUGBE): endoscopic hemostasis and proton pump inhibition are associated with improved outcomes in a real-life setting.Am J Gastroenterol. 2004; 99: 1238-1246Crossref PubMed Scopus (312) Google Scholar Without rebleeding in V patients in the U.S.3.81.95.760Nationwide Inpatient Sample (NIS)http://www.hcup-us.ahrq.gov/nisoverview.jspGoogle ScholarAbbreviations: U, bleeding due to an ulcer; NVNU, nonvariceal nonulcer etiology of bleeding; V, variceal cause of bleeding.a According to values published in Cochrane meta-analysis.11Dorward S. Sreedharan A. Leontiadis G.I. et al.Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.Cochrane Database Syst Rev. 2006; 18 (CD005415.)Google Scholarb According to values published in study by Lau et al.10Lau J.Y. Leung W.K. Wu J.C. et al.Omeprazole before endoscopy in patients with gastrointestinal bleeding.N Engl J Med. 2007; 356: 1631-1640Crossref PubMed Scopus (252) Google Scholarc This is a calculated variable whose value is determined by the chosen estimates for the proportion of low-risk and proportion of very low-risk patients among all U patients.d This is a calculated variable whose value is determined by the chosen estimates for the proportion of NVNU patients and the proportion of U patients among all the UGIB patients. Open table in a new tab Abbreviations: U, bleeding due to an ulcer; NVNU, nonvariceal nonulcer etiology of bleeding; V, variceal cause of bleeding. The unit of effectiveness was the probability of no rebleeding during the 30 days after the gastroscopy. The same model structure and probabilities estimates were used for the Canadian and American settings, but assumptions differed for each with regard to pharmacologic and hospitalization costs, as well as length of stay (LOS).17Avgerinos A. Armonis A. Manolakopoulos S. et al.Endoscopic sclerotherapy versus variceal ligation in the long-term management of patients with cirrhosis after variceal bleeding: a prospective randomized study.J Hepatol. 1997; 26: 1034-1041Abstract Full Text PDF PubMed Scopus (91) Google Scholar Model probabilities were obtained from a literature search, up to April 2007, of relevant articles in CENTRAL, EMBASE, and MEDLINE, including all randomized trials, meta-analyses, or reviews assessing PPI, greater than a single daily dose, before endoscopy for patients with suspected UGIB. Key words were “ulcer bleeding or hemorrhage, peptic ulcer, nonvariceal and gastric or duodenal erosions, rebleeding, surgery or mortality, intravenous, acid suppression, proton pump, omeprazole, lansoprazole, pantoprazole, rabeprazole, and esomeprazole.” We also used the similar articles function and performed hand-searches of articles with cross-referencing. We included all fully published human studies in French or English from which rebleeding rates could be estimated. The prevalence of bleeding lesions and the proportional repartition according to the level of risk among patients with bleeding ulcers were estimated, because individual trials and meta-analyses have shown that IVPPI given pre-endoscopy lowers the proportion of high-risk and raises that of low-risk ulcer lesions.10Lau J.Y. Leung W.K. Wu J.C. et al.Omeprazole before endoscopy in patients with gastrointestinal bleeding.N Engl J Med. 2007; 356: 1631-1640Crossref PubMed Scopus (252) Google Scholar, 11Dorward S. Sreedharan A. Leontiadis G.I. et al.Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding.Cochrane Database Syst Rev. 2006; 18 (CD005415.)Google Scholar, 13Daneshmend T.K. Hawkey C.J. Langman M.J. et al.Omeprazole versus placebo for acute upper gastrointestinal bleeding: randomised double blind controlled trial.BMJ. 1992; 304: 143-147Crossref PubMed Scopus (216) Google Scholar No effect of PPI administration pre-endoscopy on variceal or nonulcer nonvariceal lesions was modeled because of inadequate pertinent high-quality evidence. High-risk patients were defined as those with endoscopic high-risk lesions, ie, ulcers exhibiting active bleeding (spurting or oozing), a visible vessel, or an adherent clot.16Lin H.J. Lo W.C. Lee F.Y. et al.A prospective randomized comparative trial showing that omeprazole prevents rebleeding in patients with bleeding peptic ulcer after successful endoscopic therapy.Arch Intern Med. 1998; 158: 54-58Crossref PubMed Scopus (240) Google Scholar, 18Lau J.Y. Sung J.J. Lee K.K. et al.Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers.N Engl J Med. 2000; 343: 310-316Crossref PubMed Scopus (602) Google Scholar Low-risk patients included patients with pigmented dots or clean base ulcers.7Barkun A. Bardou M. Marshall J.K. Consensus recommendations for managing patients with nonvariceal upper gastrointestinal bleeding.Ann Intern Med. 2003; 139: 843-857Crossref PubMed Scopus (497) Google Scholar, 19Laine L. Peterson W.L. Bleeding peptic ulcer.N Engl J Med. 1994; 331: 717-727Crossref PubMed Scopus (666) Google Scholar Among the latter, a subgroup of very low-risk patients were identified when they also met a set of published clinical criteria1Longstreth G.F. Feitelberg S.P. Outpatient care of selected patients with acute non-variceal upper gastrointestinal haemorrhage.Lancet. 1995; 345: 108-111Abstract PubMed Google Scholar, 20Lai K.C. Hui W.M. Wong B.C. et al.A retrospective and prospective study on the safety of discharging selected patients with duodenal ulcer bleeding on the same day as endoscopy.Gastrointest Endosc. 1997; 45: 26-30Abstract Full Text Full Text PDF PubMed Scopus (84) Google Scholar, 21Cipolletta L. Bianco M.A. Rotondano G. et al.Outpatient management for low-risk nonvariceal upper GI bleeding: a randomized controlled trial.Gastrointest En
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