DRUG REVIEW. Drug Information Center, Department of Pharmacotherapy, College of Pharmacy, Washington State University, Spokane, WA

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1 DRUG REVIEW Peptic Ulcer Bleeding Following Therapeutic Endoscopy: A New Indication for Intravenous Esomeprazole Danial E. Baker, PharmD, FASCP, FASHP Drug Information Center, Department of Pharmacotherapy, College of Pharmacy, Washington State University, Spokane, WA Intravenous (IV) administration of the esomeprazole is a faster way to achieve gastric acid suppression than oral administration of the same agent. Peak suppression following IV administration occurs within hours compared with several days following oral administration. Thus, the IV administration route offers a faster onset of gastric suppression, achievement of intragastric ph closer to target levels, and better bioavailability. Treatment of peptic ulcer bleeding is the newest indication for the IV formulation of esomeprazole. The drug is effective in preventing rebleeds following endoscopic treatment when administered within 24 hours of the procedure as an 80-mg bolus followed by an IV infusion for 72 hours. What remains to be seen is whether oral therapy can be substituted for all, or part, of the 72-hour IV infusion and whether the patient can be discharged from the hospital sooner with similar outcomes. [Rev Gastroenterol Disord. 2009;9(4):E111-E118 doi: /rigd0349] 2009 MedReviews, LLC Key words: Esomeprazole Gastroesophageal reflux disease Peptic ulcer bleeding Proton pump inhibitor Esomeprazole was approved as an oral capsule formulation in the United States in February 2001 for the treatment of gastroesophageal reflux disease (GERD), including healing of erosive esophagitis, maintenance of healing of erosive esophagitis, and symptomatic GERD; and for Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence. It was approved as a delayed release suspension in October 2006; the intravenous (IV) formulation was approved in March 2005 for the short-term (up to 10 days) treatment of GERD patients with a history of erosive esophagitis as an alternative to oral therapy when use of the oral formulation is not possible or appropriate. In the United VOL. 9 NO REVIEWS IN GASTROENTEROLOGICAL DISORDERS E111

2 New Indication for IV Esomeprazole continued States, the oral capsule has exclusivity applications that expired in November 2007, April 2009, and October 2009, whereas its various patents expire beginning in 2014 and continuing through The IV formulation had exclusivity through March 2008, but its patents are valid until ,2 The newest indication for IV esomeprazole will be for the treatment of peptic ulcer bleeding (PUB) following therapeutic endoscopy. 3 If approved, esomeprazole will be the only IV proton pump inhibitor (PPI) approved for this indication (Table 1). PUB occurs when the peptic ulcer erodes into an underlying blood vessel. It is potentially life threatening The newest indication for IV esomeprazole will be for the treatment of peptic ulcer bleeding following therapeutic endoscopy. If approved, esomeprazole will be the only IV proton pump inhibitor approved for this indication. because clotting can be impaired in the acidic environment and the resulting blood loss can be significant. The incidence of PUB is approximately 50 people per 100,000 each year. Death may occur in up to 14% of patients with an acute bleed and if a patient experiences a rebleed the risk of death may be increased 3-fold The preferred treatment of PUB is endoscopic therapy. The source of the bleeding can be found in approximately 90% of patients. The hemostatic rate in these patients is high, but rebleeding can occur; it is estimated to occur in 10% to 30% of these patients and generally occurs within 3 days When pharmacotherapy is added to the endoscopic procedure its Table 1 US Food and Drug Administration-Approved Indications for Injectable Proton Pump Inhibitors 3-6 Indication Esomeprazole Lansoprazole Pantoprazole Short-term treatment (up to 7 days) X of all grades of erosive esophagitis in patients unable to take oral therapy Short-term treatment (up to 10 days) X X of GERD associated with a history of erosive esophagitis in patients for whom oral therapy is not possible or appropriate Treatment of pathologic X hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions Treatment of acute peptic ulcer X* bleeding following therapeutic endoscopy GERD, gastroesophageal reflux disease. *Pending. goal is to alter the gastric ph at the site of the bleeding. The target goal is a ph ( 6.0) above the proteolytic range for pepsin to allow stabilization of the clotting process. 13,18 Clinical Pharmacology All oral PPIs are prodrugs and require acidic activation to be effective. The oral formulation of esomeprazole is acid liable and must be protected from premature activation. The oral formulation is protected from gastric acid by filling the capsules with enteric-coated granules or making the suspension out of enteric-coated granules. 19,20 When the unprotonated prodrug is released from its protected dosage form in the duodenum, it is rapidly absorbed. Once the orally administered esomeprazole is absorbed it is activated and handled by the body just as the IV-administered esomeprazole. To be activated, the esomeprazole must penetrate the cell membrane and transverse into the parietal cell. There the molecule is protonated and trapped in the secretory canaliculus of the parietal cell and becomes the active moiety that can bind to either cysteine residue 813 within the (H /K )-adenosine triphosphatase (ATPase) enzyme, resulting in inhibition of gastric acid secretion. 4,19,21-23 The IV formulation improves the systemic bioavailability of the esomeprazole because the acidity of the stomach and the upper duodenum is avoided. Thus, more drug is delivered to the site of action during the first few days of therapy. 19,21 Mean intragastric ph over a 24- hour period was determined after 5 days of IV esomeprazole, 20 mg, and 40 mg once daily. The esomeprazole was infused intravenously over 30 minutes once daily. The percentage of time the gastric ph was 4 on day 5 was 49.5% (95% confidence interval [CI], ) with esomeprazole, E112 VOL. 9 NO REVIEWS IN GASTROENTEROLOGICAL DISORDERS

3 New Indication for IV Esomeprazole 20 mg, and 66.2% (95% CI, ) with esomeprazole, 40 mg. 4 A comparison of oral and IV esomeprazole on gastric acid suppression in patients with peptic ulcer disease was conducted to evaluate the differences in ph control achieved with both routes of administration. 24 Twenty patients were randomized to receive either IV or oral esomeprazole following their endoscopic examination. The IV group received IV esomeprazole, 80 mg, followed by 8 mg/h for 24 hours, whereas the oral group received esomeprazole, 40 mg, orally followed by a second 40-mg dose at 12 hours. Their gastric ph was then monitored over the 24-hour observation period. The ph study was completed by 9 patients in the IV arm and 8 patients in the oral arm. The IV therapy was associated with a quicker onset of action and better achievement of ph levels above 4 and 6 within the first hour of therapy and no differences in the intragastric acid profile during the subsequent 24-hour period. The results of this ph are summarized in Table 2. The limitation of this trial is the absence of comparable doses. The higher dose used in the IV arm of the study may have had some influence on the results observed within the first hour and not just the route of administration. Pharmacokinetics In studies comparing the oral and IV administration of esomeprazole, IV administration was associated with a 2-fold higher peak concentration and a 66% to 83% greater area under the plasma concentration-time curve (AUC) compared with oral administration of the same single dose. Differences were similar, but slightly less pronounced after repeated daily administration for 5 days. 25 Comparative pharmacokinetics after IV and oral administration of 20-mg and 40-mg doses are summarized in Table 3. The bioavailability of oral esomeprazole is approximately 78% Table 2 Comparison of Intragastric Acid Profile Following Oral and IV Administration of Esomeprazole in Patients with Peptic Ulcer Disease 24 Esomeprazole, Esomeprazole, Parameter 40 mg (Oral) 80 mg (IV) P Value 1st hour Intragastric ph (median) Percentage of time ph 4 0.1% 49%.04 Time to achieve ph 4 (median) 102 min 25 min.01 Time to achieve ph 6 (median) 125 min 28 min hours Intragastric ph (median) Percentage of time ph % 92.4% Percentage of time ph % 91.2% IV, intravenous. of that of IV esomeprazole. 25 Esomeprazole is 97% plasma protein bound. The apparent volume of distribution at steady-state is approximately 16 L. 4 Esomeprazole is eliminated primarily by hepatic metabolism via CYP2C19 and CYP3A4, with the CYP2C19 pathway the predominant metabolite route. 4,26 Less than 1% of the dose is excreted unchanged in the In studies comparing the oral and IV administration of esomeprazole, IV administration was associated with a 2-fold higher peak concentration and a 66% to 83% greater area under the plasma concentration-time curve compared with oral administration of the same single dose. urine. 4 The elimination half-life of esomeprazole is 1.1 to 1.4 hours. 4 Its metabolites are inactive. 4 Polymorphism influences the rate of metabolism of esomeprazole via the CYP2C19 isoenzyme pathway. Lack of this isoenzyme occurs in 3% of whites and 15% to 20% of the Asian population. These individuals are classified as poor metabolizers and their AUC can be 2-fold higher than the extensive metabolizers. 4 The elimination half-life is also increased with increasing doses of esomeprazole. 4 The same recommendations for dosage adjustments in special populations are suggested for both IV and oral esomeprazole. With oral esomeprazole, the AUC and peak concentration were increased slightly in the elderly; however, dosage adjustments based on age are not necessary. 4 The pharmacokinetics of oral and IV esomeprazole have not been studied in patients under age 18 years. 4 The AUC and peak concentration of esomeprazole were slightly increased in women compared with men with both oral and IV administration; however, dosage adjustment based on sex is not necessary. 4 Because less than 1% of the esomeprazole dose is eliminated unchanged in VOL. 9 NO REVIEWS IN GASTROENTEROLOGICAL DISORDERS E113

4 New Indication for IV Esomeprazole continued Table 3 Comparative Pharmacokinetics of IV and Oral Esomeprazole 25 the urine, renal impairment is not expected to significantly affect the pharmacokinetics of esomeprazole. 4 The pharmacokinetics of oral esomeprazole were not altered in patients with mild to moderate hepatic impairment (Child Pugh Classes A and B). In patients with severe hepatic insufficiency (Child Pugh Class C), the AUC of esomeprazole was 2- to 3-fold higher than what is observed in subjects with normal hepatic function. In patients with severe hepatic impairment (Child Pugh Class C), a dose of 20 mg once daily should not be exceeded. 4 Clinical Efficacy A small pilot study was conducted in China to evaluate the potential use of oral esomeprazole for the prevention of rebleed from a bleeding peptic ulcer following endoscopic treatment. This study enrolled 70 patients with bleeding peptic ulcers. The bleeding was first handled with endoscopic treatment and the patients were then randomized to receive oral esomeprazole, 40 mg, or placebo twice daily for 3 days. The primary endpoint was the incidence of rebleeding within 30 days. Rebleeding occurred in 5.7% of the esomeprazole group and 8.6% of the placebo group (P.999). The number of transfusions and duration 20 mg 40 mg IV Oral IV Oral C max day mol/l 0.78 mol/l 6.77 mol/l 2.97 mol/l C max day mol/l 1.57 mol/l 7.51 mol/l 4.6 mol/l AUC day mol h/l 1.86 mol h/l 9.88 mol h/l 5.94 mol h/l AUC day mol h/l 3.92 mol h/l mol h/l mol h/l T 1/ h 1.12 h 1.41 h 1.38 h AUC, area under the curve; C max, maximum concentration; IV, intravenous; T 1/2, elimination half-life. of hospitalization following the endoscopic treatment were similar in both groups. 27 The pivotal trial for the use of IV esomeprazole in the treatment of PUB was a randomized, multicenter, double-blind, placebo-controlled study. This study was conducted in 91 centers in 16 countries. It enrolled 767 high-risk patients who had undergone endoscopic hemostasis for PUB. The patients had to be older than age 18 years, have an upper gastrointestinal (GI) bleeding within the last 24 hours, 1 endoscopically confirmed bleeding gastric or duodenal ulcer 5 mm in diameter, and successful hemostasis following the endoscopic treatment. Patients were excluded for various medical reasons associated with bleeding, GI abnormalities, major cardiovascular event within the last 3 months, or severe hepatic or renal disease. They were also excluded if they had received an IV PPI within 24 hours of study enrollment or required treatment with H 2 -receptor antagonists, sucralfate, prostaglandins, nonsteroidal anti-inflammatory agents, aspirin, clopidogrel, somatostatin, tranexamic acid, heparin, warfarin, phenytoin, clarithromycin, itraconazole, ketoconazole, cisapride, atazanavir, or ritonavir during the first 7 days after study enrollment. 28,29 The target sample size for the study was 760 patients; this number was based on an estimated rebleed rate of 15% with placebo and 7% with esomeprazole. It was powered at 90% for a 5% significance level and allowed for 10% exclusion rate for protocol violations. The intent-totreat (ITT) population consisted of all patients who were enrolled and received any part of an infusion of esomeprazole or placebo. The per protocol population excluded patients who discontinued the study early, subjects who received less than 70% of the planned infusion doses, and individuals with major deviations from the protocol. 28 Patients were randomized to postendoscopic prophylaxis with a bolus dose of the study drug followed by a maintenance infusion. The study drug bolus (375 treated with placebo and 389 treated with esomeprazole, 80 mg) was administered as an IV infusion over 30 minutes. The maintenance infusion (placebo or esomeprazole, 8 mg/h) was initiated immediately after the bolus dose and continued for 71.5 hours. All patients were then switched to oral therapy with esomeprazole, 40 mg, once daily, before breakfast, for 27 days. 28 The primary endpoint was the incidence of rebleeding from the peptic ulcer within the first 72 hours of therapy using the ITT population. If hematemesis occurred, the patient underwent an endoscopic examination to confirm the source of the bleeding. Rebleeding within 72 hours of therapy initiation in the ITT population was 5.9% in the IV esomeprazole group, and 10.3% in the placebo group (P.026). 30 This represented a 43% risk reduction for rebleeding and the number needed to treat (NNT) with IV esomeprazole to avoid a rebleed was Rebleeding within 72 hours of therapy initiation in the per protocol population was 4.8% in E114 VOL. 9 NO REVIEWS IN GASTROENTEROLOGICAL DISORDERS

5 New Indication for IV Esomeprazole Table 4 Secondary Endpoint From the IV Esomeprazole Versus Placebo Treatment of PUB (ITT Population) 29,30 Esomeprazole IV Placebo Parameter (n 375) (n 389) P Value Rebleed 7 days 7.2% 12.9%.0096 Rebleed 30 days 7.7% 13.6%.0092 All-cause mortality 30 days 0.8% 2.1%.22 Surgery 30 days 2.7% 5.4%.059 Endoscopic retreatment 30 days 6.4% 11.6%.012 No. of blood units transfused 30 days No. of days hospitalized due to rebleed 30 days ITT, intent-to-treat; IV, intravenous; PUB, peptic ulcer bleeding. the IV esomeprazole group, and 10.4% in the placebo group (P.0093). 29,30 This represented a 54% risk reduction for rebleeding and the NNT with IV esomeprazole to avoid a rebleed was The results for the secondary endpoints from this study are summarized in Table 4. A decision-tree model was developed with the data from this pivotal study to determine the costeffectiveness of IV esomeprazole in the follow-up treatment of PUB. The model used a 30-day time horizon using a US third-party payor perspective. The costs used in the model were extracted from national US databases and expressed in 2007 American dollars. The estimated cost associated with the esomeprazole therapy was $14,290 and the cost associated with the placebo therapy was $14,240. Thus, the incremental cost-effectiveness ratio was $913 per rebleed averted with the esomeprazole therapy. 31 Whether esomeprazole doses this high are necessary for all patients is unknown because dose-ranging studies were not conducted. However, a high- versus low-dose study was conducted using omeprazole and pantoprazole; the PPI used in the study was determined by the investigator based on local availability. Patients admitted with overt GI bleeding, recent history ( 24 h before presentation) of hematemesis and/or melena, or ulcer hemorrhage beginning after hospitalization for an unrelated medical or surgical condition were eligible. They were then randomized to receive IV treatment with either high- (n 243) or low-dose (n 239) PPI therapy for 72 hours postprocedure. The highdose group was treated with an 80-mg bolus of the PPI followed by 8 mg/h as a continuous infusion for 72 hours; the low-dose group was treated with a 40-mg bolus daily followed by saline infusion for 72 hours. After 72 hours both groups were converted to 20-mg oral therapy twice daily until discharge. The primary endpoint was the occurrence of rebleeding during the hospitalization. Rebleeds occurred in 11.8% of the high-dose group and in 8.1% of the low-dose group (P.18). Most of the rebleeds occurred within the first 72 hours (6.7% and 9.3%, respectively; P.32). 32 There are no direct comparisons of the efficacy of oral and IV esomeprazole in the prevention of bleeding peptic ulcers postendoscopic treatment or information on the impact of converting IV esomeprazole therapy to oral esomeprazole earlier in the course of therapy in an attempt to decrease the duration of hospitalization. Several investigators have attempted to evaluate the possible differences between IV and oral treatment with a PPI when used as postendoscopic treatment in patients with acute nonvariceal upper GI bleeding. A retrospective evaluation conducted in Canada found no difference in the incidence of rebleeding, surgery, mortality, readmission for upper GI bleeding, and transfusions in patients treated with IV and oral PPIs. The IV PPI group received various agents via continuous infusion or intermittent IV boluses, whereas the oral group received at least 40 mg of omeprazole per day or an equipotent dose of an alternative PPI. These authors believe these results are suggestive that oral therapy may be an effective alternative to IV therapy. 33 Contraindications Use of any of the injectable PPIs is contraindicated in patients with known hypersensitivity to the drug, other substituted benzimidazoles (eg, omeprazole, pantoprazole, lansoprazole, rabeprazole), or any of the formulation ingredients. 4-6 Warnings and Precautions Treatment with the IV formulation should be discontinued as soon as the patient is able to resume treatment with an oral esomeprazole. 4 Symptomatic response to therapy with any esomeprazole does not preclude the presence of gastric malignancy. 4 The safety and effectiveness of any of these PPIs has not been established in pediatric patients. 4 VOL. 9 NO REVIEWS IN GASTROENTEROLOGICAL DISORDERS E115

6 New Indication for IV Esomeprazole continued Esomeprazole is a Pregnancy Category B drug. Esomeprazole should only be used during pregnancy if clearly needed. 4 Esomeprazole excretion in breast milk has not been assessed; however, omeprazole concentrations have been measured in breast milk following omeprazole therapy. Discontinuation of either nursing or esomeprazole is recommended in breastfeeding mothers due to the potential risks of adverse effects. 4 Adverse Reactions All PPIs are well tolerated. 4 Common adverse effects associated with esomeprazole therapy include headache, flatulence, nausea, dyspepsia, and abdominal pain. Reactions specific to the IV route have included mild itching at the injection site and mild focal erythema at the IV insertion site. The incidence and nature of adverse effects did not appear to differ between oral and IV administration. 4,20 Drug Interactions Changes in ph may influence the absorption of some drugs from the stomach. PPIs may decrease the absorption of ketoconazole, ampicillin esters, and iron salts, and may increase the absorption of benzyl penicillin by raising the ph of the stomach. 4 Esomeprazole is extensively metabolized in the liver via CYP2C19 and CYP3A4. 4 Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1, or 3A4. Drug interactions are not anticipated with substrates of these enzymes. Drug-interaction studies have shown that esomeprazole does not have any clinically important interactions with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin. However, postmarketing reports have described increases in international normalized ratio and prothrombin time in patients receiving concomitant esomeprazole and warfarin. Monitoring is recommended in patients receiving this combination. 4 Esomeprazole may interfere with CYP2C19. Administration of esomeprazole, 30 mg, with diazepam, a CYP2C19 substrate, resulted in a 45% reduction in diazepam clearance and increased diazepam plasma levels. This drug interaction is not believed to be clinically important. 4 Concomitant administration with inhibitors of CYP2C19 and CYP3A4 (eg, voriconazole) may cause a 2-fold increase in the esomeprazole exposure. Dosage adjustments are not required, but the prescriber may consider adjustments in patients requiring higher doses of esomeprazole. 4 Concomitant use with atazanavir and nelfinavir is not recommended because the serum levels of these drugs may be decreased to ineffective levels. 4 Although concomitant use with saquinavir/ritonavir may be associated with elevated saquinavir levels and toxicity, a reduction in saquinavir dose may be appropriate. 4 The pharmacokinetics of esomeprazole were not altered by concomitant administration of diazepam, phenytoin, oral contraceptives, or quinidine. 4 Concomitant administration with naproxen or rofecoxib did not result in changes in the pharmacokinetics of esomeprazole or either of the nonsteroidal anti-inflammatory drugs. 4 Dosing The recommended dose of injectable esomeprazole is 20 mg or 40 mg once daily by IV injection (no less than 3 min) or IV infusion (10-30 min) for the treatment of GERD patients with a history of erosive esophagitis as an alternative to oral therapy when use of the oral formulation is not possible or appropriate. 4 Treatment with the IV formulation should be discontinued as soon as the patient is able to resume treatment with an oral esomeprazole. 4 The dose of esomeprazole used for the treatment of PUB following therapeutic endoscopy is 80-mg IV over 30 minutes followed by an IV infusion of 8 mg/h for 71.5 hours Esomeprazole should not be administered concomitantly with any other medications through the same site or tubing. The line should always be flushed with either 0.9% Sodium Chloride Injection USP, Lactated Ringer s Injection USP, or 5% Dextrose Injection USP (Hospira, Inc., Lake Forest, IL) prior to and after administration of the esomeprazole. 4 A dose of 20 mg should not be exceeded in patients with severe hepatic impairment (Child Pugh Class C). No dosage adjustments are necessary in the elderly, patients with renal dysfunction, or based on sex. 4 Conclusions IV administration of esomeprazole is a faster way to achieve gastric acid suppression than oral administration of the same agent. Peak suppression following IV administration occurs within hours compared with several days following oral administration. Thus, the IV administration route offers a faster onset of gastric suppression, achievement of intragastric ph closer to target levels, and better bioavailability. Treatment of PUB is the newest indication for the IV formulation of esomeprazole. The drug is effective in preventing rebleeds following endoscopic treatment when administered within 24 hours of the procedure as an 80-mg bolus followed by an IV infusion for 72 hours. What remains to be seen is whether oral therapy can be substituted for all, or part, of the 72-hour IV infusion E116 VOL. 9 NO REVIEWS IN GASTROENTEROLOGICAL DISORDERS

7 New Indication for IV Esomeprazole and whether the patient can be discharged from the hospital sooner with similar outcomes. References 1. Center for Drug Evaluation and Research, Food and Drug Administration. Esomeprazole sodium, Application # Orange book: approved drug products with therapeutic equivalence evaluations, Available at: gov/cder/ob/default.htm. Accessed February 10, Center for Drug Evaluation and Research, Food and Drug Administration. Drugs FDA Approved Drug Products, Available at: accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed February 10, AstraZeneca submits snda for Nexium I.V. for peptic ulcer bleed indication [press release]. Wilmington, DE: AstraZeneca LP. May 30, Available at: search/?itemid= Accessed February 10, Nexium I.V. (esomeprazole sodium) for injection [package insert]. Wilmington, DE: AstraZeneca LP; Available at: iv.pdf. Accessed February 10, Prevacid I.V. (lansoprazole) for injection [package insert]. Chicago, IL: Takeda Pharmaceuticals America, Inc.; Available at: abbott.com/prevacidiv.pdf?nocache=. Accessed February 10, Protonix I.V. (pantoprazole sodium) for injection [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; Available at: Accessed February 10, Lassen A, Hallas J, Schaffalitzky de Muckadell OB. Complicated and uncomplicated peptic ulcers in a Danish county : a populationbased cohort study. Am J Gastroenterol. 2006; 101: Kang JY, Elders A, Majeed A, et al. Recent trends in hospital admissions and mortality rates for peptic ulcer in Scotland Aliment Pharmacol Ther. 2006;24: Soplepmann J, Peetsalu A, Peetsalu M, et al. Peptic ulcer haemorrhage in Tartu County, Estonia: epidemiology and mortality risk factors. Scand J Gastroenterol. 1997;32: Thomsen RW, Riis A, Christensen S, et al. Diabetes and 30-day mortality from peptic ulcer bleeding and perforation: a Danish populationbased cohort study. Diabetes Care. 2006;29: Mose H, Larsen M, Riis A, et al. Thirty-day mortality after peptic ulcer bleeding in hospitalized patients receiving low-dose aspirin at time of admission. Am J Geriatr Pharmacother. 2006; 4: Jensen DM. Current diagnosis and treatment of severe ulcer hemorrhage. ASGE Clin Update. 1999;6: Lin HJ, Lo WC, Lee FY, 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: Lau JY, Sung JJ, Lee KK, et al. Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. N Engl J Med. 2000;343: Kovacs TO, Jensen DM. The short-term medical management of non-variceal upper gastrointestinal bleeding. Drugs. 2008;68: Gralnek IM, Barkun AN, Bardou M. Management of acute bleeding from a peptic ulcer. N Engl J Med. 2008;359: Elmunzer BJ, Young SD, Inadomi JM, et al. Systematic review of the predictors of recurrent hemorrhage after endoscopic hemostatic therapy for bleeding peptic ulcers. Am J Gastroenterol. 2008;103: Green FW Jr, Kaplan MM, Curtis LE, et al. Effect of acid and pepsin on blood coagulation and platelet aggregation. A possible contributor prolonged gastroduodenal mucosal hemorrhage. Gastroenterology. 1978;74: Freston JW. Therapeutic choices in reflux disease: defining the criteria for selecting a proton pump inhibitor. Am J Med. 2004;117(suppl 5A): 14S-22S. 20. Nexium (esomeprazole magnesium) [package insert]. Wilmington, DE: AstraZeneca LP; Available at: pi/nexium.pdf. Accessed February 10, Devlin JW, Welage LS, Olsen KM. Proton pump inhibitor formulary considerations in the acutely ill Part 1: Pharmacology, pharmacodynamics, and available formulations. Ann Pharmacother. 2005;39: Main Points The intravenous (IV) formulation of esomeprazole was approved in March 2005 for the short-term treatment of gastroesophageal reflux disease (GERD) patients with a history of erosive esophagitis as an alternative when use of the oral formulation is not possible or not appropriate. The IV route of esomeprazole allows for the fastest onset of gastric suppression, achievement of intragastric ph closer to target levels, and better bioavailability. The newest indication is for the treatment of peptic ulcer bleeding, and if approved, it will be the only IV proton pump inhibitor approved for this indication. In a comparison study, the IV esomeprazole therapy was associated with a better onset of action and achievement of ph levels above 4 and 6 within the first hour of therapy with no differences observed in the intragastric acid profile for the subsequent 24-hour period. The pivotal trial for IV esomeprazole use in the treatment of PUB was a randomized, multicenter, double-blind, placebo-controlled study where the primary endpoint was the incidence of rebleeding from the peptic ulcer within the first 72 hours of therapy using the intent-to-treat (ITT) population. Rebleeding within 72 hours of therapy initiation in the ITT population was 5.9% in the IV esomeprazole group, and 10.3% in the placebo group a 43% risk reduction for rebleeding and the number needed to treat (NNT) with IV esomeprazole to avoid a rebleed was Rebleeding within 72 hours of therapy initiation in the per protocol population was 4.8% in the IV esomeprazole group, and 10.4% in the placebo group, representing a 54% risk reduction for rebleeding and the NNT with IV esomeprazole to avoid a rebleed was All proton pump inhibitors are well tolerated with the incidence and nature of adverse effects not appearing to differ between oral and IV administration. Common adverse effects associated with esomeprazole include headache, flatulence, nausea, dyspepsia, and abdominal pain. Reactions specific to the IV route include mild itching at the injection site and mild focal erythema at the IV insertion site. VOL. 9 NO REVIEWS IN GASTROENTEROLOGICAL DISORDERS E117

8 New Indication for IV Esomeprazole continued 22. Keating GM, Figgitt DP. Intravenous esomeprazole. Drugs. 2004;64: Julapalli VR, Graham DY. Appropriate use of intravenous proton pump inhibitors in the management of bleeding peptic ulcer. Dig Dis Sci. 2005;50: Wong SKH, Yang GPC, Daniel CTM, et al. Oral vs intravenous infusion of esomeprazole on gastric acid suppression in patients with peptic ulcer disease a randomized trial [abstract]. J Gastroenterol Hepatol. 2007(suppl 2);22:A Wilder-Smith CH, Bondarov P, Lundgren M, et al. Intravenous esomeprazole (40 mg and 20 mg) inhibits gastric acid secretion as effectively as oral esomeprazole: results of two randomized clinical studies. Eur J Gastroenterol Hepatol. 2005;17: Hassan-Alin M, Andersson T, Bredberg E, et al. Pharmacokinetics of esomeprazole after oral and intravenous administration of single and repeated doses to healthy subjects. Eur J Clin Pharmacol. 2000;56: Wei KL, Tung SY, Sheen CH, et al. Effect of oral esomeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. J Gastroenterol Hepatol. 2007;22: Sung JJY, Mössner J, Barkun A, et al. Intravenous esomeprazole for prevention of peptic ulcer re-bleeding: rationale/design of Peptic Ulcer Bleed study. Aliment Pharmacol Ther. 2008;27: Barkun A, Sung JJY, Kuipers JE, et al. Intravenous esomeprazole for prevention of peptic ulcer re-bleeding in a predominantly Caucasian population: results on clinical benefits and hospital resource use [abstract]. Presented at the 39th Nordic Meeting of Gastroenterology, June 4-6, 2008; Helsinki, Finland. 30. Sung JJY, Barkun A, Kuipers EJ, et al. Intravenous esomeprazole for prevention of peptic ulcer re-bleeding: a multinational, randomised, placebo-controlled study [abstract]. Presented at the 39th Nordic Meeting of Gastroenterology, June 4-6, 2008; Helsinki, Finland. 31. Barkun A, Adam V, Sung J, et al. The costeffectiveness of high-dose intravenous esomeprazole in peptic ulcer bleeding a U.S. cost perspective. Am J Gastroenterol. 2008;103(suppl 1):S Andriulli A, Loperfido S, Focareta R, et al. Highversus low-dose proton pump inhibitors after endoscopic hemostasis in patients with peptic ulcer bleeding: a multicentre, randomized study. Am J Gastroenterol. 2008;103: Murthy S, Keyvani L, Leeson S, et al. Intravenous versus high-dose oral proton pump inhibitor therapy after endoscopic hemostasis of high-risk lesions in patients with acute nonvariceal upper gastrointestinal bleeding. Dig Dis Sci. 2007;52: E118 VOL. 9 NO REVIEWS IN GASTROENTEROLOGICAL DISORDERS

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