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American Journal of Critical Care. 2008;17: 142-147
Copyright © 2008 by the American Association of Critical-Care Nurses.
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Famotidine Versus Pantoprazole for Preventing Bleeding in the Upper Gastrointestinal Tract of Critically Ill Patients Receiving Mechanical Ventilation

By Kizito Ojiako, MD, FRCS, (Eng), Hiren Shingala, MD, Christa Schorr, RN, BSN and David R. Gerber, DO. Kizito Ojiako is a fellow in critical care medicine, Hiren Shingala is a resident in internal medicine, Christa Schorr is a project impact administrative specialist, and David R. Gerber is associate director of the medical-surgical intensive care unit at Cooper University Hospital, Camden, New Jersey. Gerber is also an associate professor of medicine at the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, in Camden.

Corresponding author: David R. Gerber, DO, FCCP, Division of Critical Care Medicine, Dorrance 372B, Cooper University Hospital, Camden, NJ 08103 (e-mail: gerber-dave @cooperhealth.edu).


   Abstract
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Methods
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 Discussion
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 References
 
Background Mechanical ventilation increases risk for bleeding in the upper part of the gastrointestinal tract. Proton pump inhibitors, although they are more potent and longer acting inhibitors of gastric acid production than are histamine2 antagonists, also are generally more expensive. Data comparing the 2 types of agents for preventing gastrointestinal bleeding in critically ill patients are limited.

Objectives To compare the effectiveness of famotidine (a histamine2 antagonist) and pantoprazole (a proton pump inhibitor) in preventing stress ulcers in critically ill patients receiving mechanical ventilation.

Methods Data were collected from the Project Impact database. All patients who received mechanical ventilation for more than 48 hours from November 2002 to June 2006 and were treated with either drug were included. Patients receiving other drugs or with known bleeding in the upper part of the gastrointestinal tract, thrombocytopenia, or coagulopathy were excluded.

Results A total of 522 patients who received famotidine and 95 who received pantoprazole were included. Bleeding in the upper part of the gastrointestinal tract was more common in patients receiving pantoprazole than in patients receiving famotidine (0.38% vs 3.2%, P= .03). Although scores on the Acute Physiology and Chronic Health Evaluation II were higher in patients who received pantoprazole (P= .01), other outcome measures did not differ significantly between groups. Bleeding in the upper part of the gastrointestinal tract was more frequent among dialysis patients receiving pantoprazole than among those receiving famotidine.

Conclusions Famotidine and pantoprazole are similarly effective for preventing bleeding in the upper part of the gastrointestinal tract in patients receiving mechanical ventilation.

Prophylaxis to prevent bleeding in the upper part of the gastrointestinal tract is a routine practice in intensive care units (ICUs). The primary risk factors for the development of upper gastrointestinal bleeding (UGIB) are the need for more than 48 hours of mechanical ventilation and coagulopathy.1 UGIB occurring in ICUs ranges from the detection of occult blood in gastric aspirates to frank, potentially exsanguinating hemorrhage. Such bleeding results primarily from a loss of gastric mucosal integrity, often exacerbated by hyperacidity and mucosal ischemia.

Although uncommon, UGIB is associated with a significant increase in mortality.1 Numerous pharmacological agents have been used to prevent UGIB in high-risk patients, including antacids, sucralfate, histamine2 receptor antagonists (H2RAs), and proton pump inhibitors (PPIs). PPIs induce a greater degree and duration of gastric pH elevation than do H2RAs and consequently have been widely used as prophylactic agents in recent years. However, data comparing the clinical effectiveness of these 2 classes of drugs are limited. For this reason, we evaluated the incidence of clinically significant UGIB in patients receiving mechanical ventilation and being treated with these agents.


   Methods
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This study was a retrospective review of patient data collected in a 24-bed medical-surgical ICU of Cooper University Hospital in Camden, New Jersey. Permission for the study was obtained from the hospital’s institutional review board. All patients who required mechanical ventilation for more than 48 hours and who received prophylaxis against UGIB with either H2RAs or PPIs from November 2002 through June 2006 were identified from the Project Impact database (Cerner Corporation, Kansas City, Missouri). Project Impact is a critical care data system that incorporates clinical, demographic, and acuity data on critically ill patients. Data, including diagnoses, active interventions, and laboratory parameters, are prospectively abstracted from patients’ records for inclusion in the Project Impact database by an experienced nurse during the patient’s ICU admission.

Hospital records were reviewed to confirm that patients included in the analysis received medication from just 1 of these classes of drugs and that patients who received medications from both classes were excluded from analysis. Patients with a known or suspected history of UGIB, active UGIB, thrombocytopenia (platelet count <100 000/µL), or coagulopathy (prothrombin time or activated partial thromboplastin time ≥1.5 times the upper limit of normal without the use of anticoagulants) were excluded, as were patients who had received either class of medication before admission.

Famotidine is the formulary H2RA and pantoprazole is the formulary PPI at Cooper University Hospital, and all patients in the study received 1 of these 2 medications. Typical dosing of these agents for prophylaxis of UGIB at our institution is 40 mg once daily for pantoprazole and 20 mg twice daily for famotidine (reduced to once daily in patients with renal failure). Patients are routinely treated via the enteral route once they can tolerate administration of medications by this route. Gastric pH is not monitored, and other agents (eg, sucralfate, antacids) are not used for the prevention of UGIB in our unit.


Major risk factors for upper gastrointestinal bleeding are mechanical ventilation for more than 48 hours or coagulopathy.

 

Data collected included age, acuity, class of drug (H2RA or PPI), mortality, occurrence of UGIB, length of stay in the ICU and in the hospital, anticoagulant use, history of end-stage renal disease that required hemodialysis, and occurrence of ventilator-associated pneumonia. All data except those on medications were obtained from the Project Impact database. Medication information (use of H2RAs or PPIs) was obtained from patients’ records.

The definitions of gastrointestinal bleeding and ventilator-associated pneumonia used in this study were those used for identification of those phenomena in the Project Impact database. Gastrointestinal bleeding is defined as blood loss from the upper or lower part of the gastrointestinal tract that required transfusion of 1 unit or more of blood products. Only patients with a bleeding source in the upper part of the gastrointestinal tract were classified as having bleeding for the purposes of this study. Patients were identified in the Project Impact database as having UGIB if this clinical diagnosis was made in the chart and the patient received at least 1 unit of packed red blood cells.


Clinically significant gastrointestinal bleeding in critically ill patients is uncommon.

 

The diagnosis of ventilator-associated pneumonia requires new findings on physical examination or chest radiograph consistent with pneumonia in a patient receiving mechanical ventilation and at least one supporting form of evidence (eg, cultures of blood or sputum samples from deep in the respiratory tract that were positive for pathogenic organisms, new development of purulent sputum, appropriately elevated antibody titers, histopathological changes consistent with pneumonia).

The primary objective of this study was to compare the incidence of clinically significant UGIB in patients receiving H2RAs with the incidence in patients receiving PPIs as prophylactic agents. The secondary objective was to evaluate other outcome measures (frequency of ventilator-associated pneumonia, mortality, and length of stay) in these 2 groups.

Continuous variables were analyzed by using the Mann-Whitney U test and were tested for normalcy by using the Kolmogorov-Smirnov test. Values were adjusted for nonnormal distribution by using previously described methods.2 Categorical variables were compared by using the Fisher exact test.


   Results
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Discussion
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A total of 617 eligible patients with evaluable records were identified, 522 in the group that received famotidine and 95 in the group that received pantoprazole. All patients were started on parenteral therapy. A total of 357 patients in the famotidine group and 67 in the pantoprazole group were switched to enteral therapy during their ICU stay (P =.72). Patients were similar with respect to age, but patients in the PPI group had higher acuity as indicated by scores on the Acute Physiology and Chronic Health Evaluation II (APACHE II; see TableGo). Although the incidence of UGIB was low (2/522, 0.38%, in the H2RA group vs 3/95, 3.2%, in the PPI group), this complication occurred significantly more often (P =.03) among patients receiving PPI. Length of stay, mortality, incidence of ventilator-associated pneumonia, incidence of end-stage renal disease requiring hemodialysis, use of therapeutic anticoagulation, and the incidence of bleeding in patients receiving anticoagulants were similar for both groups. Although patients who required hemodialysis accounted for a small percentage of both groups, 3 of 5 instances of UGIB occurred in this subgroup (in 1 of 2 patients receiving the H2RA, in 2 of 3 receiving the PPI). The incidence of UGIB in patients undergoing long-term treatment with hemodialysis also was significantly greater in the PPI group, although, again, the numbers were small. Among patients without a history of chronic renal failure, the incidence of UGIB did not differ between the groups (see TableGo).


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  		Table Patients’ characteristics and outcome parametersa

 

   Discussion
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Clinically significant gastrointestinal bleeding in critically ill patients is relatively uncommon, and its onset appears to be largely limited to specific populations of high-risk patients.1,3–5 In a landmark article published by Cook et al,1 respiratory failure requiring more than 48 hours of mechanical ventilation and coagulopathy were the principal conditions associated with an increased risk of new-onset gastrointestinal hemorrhage in the ICU. The incidence of such hemorrhage was 2% in the patients with respiratory failure and 0.5% in the patients with coagulopathy.

The optimal regimen to prevent development of this complication in high-risk patients remains unclear. Studies6–10 comparing antacids, H2RAs, and sucralfate have not provided convincing data on the superiority of any of these agents. Although some researchers10–13 have suggested that drugs that increase the gastric pH (H2RAs, antacids) may be associated with an increased incidence of nosocomial pneumonia, data from other studies6,9,14–16 contradict this conclusion.

Since their development, PPIs have gained popularity with many clinicians as agents for preventing gastrointestinal bleeding in critical care settings. PPIs have greater pharmacological efficacy than do H2RAs, as indicated by both the degree and duration of pH elevation they induce.17–19 In addition, the development of thrombocytopenia, a well-documented complication of H2 blockade, is rarely associated with use of PPIs.20 Despite these theoretical advantages of PPIs, few data are available to compare the effectiveness of this class of drug with the effectiveness of H2RAs in the clinical setting.

In 1997, Levy et al21 reported on a comparison between ranitidine (an H2RA) and omeprazole (a PPI) for the prevention of gastrointestinal bleeding in critically ill patients. In that study, which included only 67 patients, the incidence of bleeding was significantly lower in the patients receiving the PPI (6% vs 31%, P < .05). However, although both groups had similar acuity as indicated by APACHE II scores, the group that received ranitidine had significantly more risk factors for gastrointestinal hemorrhage than did the group that was given the PPI (2.7 vs 1.9). Mechanical ventilation was more common in the group given ranitidine, as were conditions such as shock, trauma, and major neurological injury, among others, which in that study were classified as risk factors.

More recently, in a placebo-controlled randomized trial that included patients receiving mechanical ventilation and patients with coagulopathy, Kantorova et al10 were unable to show any difference in the rate of gastrointestinal bleeding in patients receiving an H2RA, a PPI, or sucralfate. Interestingly, in that study, patients receiving placebo had a low rate of bleeding similar to that of patients receiving prophylaxis, with bleeding rates of 3% with the H2RA, 1% with the PPI, 4% with sucralfate, and 1% with the placebo (P > .28).

In a noninferiority study (ie, a study designed with the goal of showing equivalent efficacies of these 2 therapies), Conrad et al18 compared oral omeprazole with intravenous cimetidine in patients receiving mechanical ventilation and found similar rates of significant UGIB in the 2 groups. Conrad et al also reported significantly greater elevation of gastric pH with omeprazole than with cimetidine. In that study,18 the definition of clinically significant bleeding was based solely on persistence of evidence of bleeding (eg, bright red blood not clearing with saline lavage, presence of coffee-ground material containing occult blood for greater than 8 hours, or recurrence of coffee-ground material containing occult blood for several consecutive days), without reference to defined clinical effect (hemodynamic changes, decreasing hematocrit or hemoglobin level, need for transfusion), unlike the definitions used by other investigators.1,8,21 In a recent study in which pantoprazole was compared with ranitidine for preventing rebleeding of ulcers, Jensen et al22 found no significant differences in outcomes between the 2 groups, although rebleeding tended to occur less often in the patients treated with the PPI.


Proton pump inhibitors have greater efficacy in both degree and duration of pH elevation compared to histamine2 antagonists.

 

Although our study was retrospective, it appears to be the largest report in which an H2RA was compared with a PPI for the prevention of UGIB in critically ill patients. In our study, patients receiving the PPI had a significantly higher incidence of gastrointestinal bleeding than did patients given the H2RA (3.2% vs 0.38%), although the total number of patients with clinically important bleeding was small. The reasons for this difference are unclear, although the somewhat higher acuity among the patients given the PPI raises the question of whether their higher acuity was a factor in their greater incidence of bleeding.

Researchers in previous studies1,3 have not reported higher acuity scores in patients with UGIB than in patients without UGIB. In addition, mortality, history of renal failure requiring hemodialysis, incidence of ventilator-associated pneumonia, age, length of stay (in the hospital and in the ICU), and duration of mechanical ventilation were similar between our 2 groups, suggesting that the difference in APACHE II scores was not clinically important.

We speculate that the difference in APACHE II scores between the 2 groups may reflect a propensity to use PPIs in sicker patients because PPIs are perceived as more effective agents, although most patients received H2RAs, reflecting the general practice in our institution. The tendency for gastrointestinal bleeding to occur in patients with end-stage renal disease is consistent with previous data indicating that renal failure is a risk factor for bleeding in patients receiving mechanical ventilation.23


Patients receiving proton pump inhibitors had a significantly higher incidence of GI bleeding than did those receiving H2RA prophylaxis.

 

We excluded patients with preexisting thrombocytopenia because including them might have biased the results. Patients with this condition may be at increased risk of bleeding from any site. In addition, in our ICU, patients with thrombocytopenia are much more likely to receive a PPI, given the significantly lower likelihood of thrombocytopenia being exacerbated by such a drug as compared with an H2RA. Thus, inclusion of patients with thrombocytopenia may have increased the incidence of bleeding in the PPI group as a result of the thrombocytopenia rather than because of a lack of effectiveness of these drugs.

The primary limitation of this study is that it was a retrospective evaluation of data from a clinical database. Although data are collected prospectively on all patients in the ICU for inclusion in the Project Impact database, data are included according to specific definitions that may differ from the definitions used by some clinicians or in other studies. Therefore, some patients with UGIB possibly were not identified for inclusion in this study. Gastrointestinal bleeding is identified in Project Impact if the bleeding is clinically detected and triggers a transfusion of packed red blood cells; bleeding episodes not severe enough to require this intervention will be missed.

Definitions of UGIB used have varied markedly from study to study.1,7,20 The definition we used seems like a practical method of detecting clinically meaningful episodes of bleeding. We think it is therefore unlikely that significant episodes of bleeding went unrecognized in these patients. The overall incidence of gastrointestinal bleeding we found was consistent with the incidences reported by previous investigators.1,5 Also, as with many retrospective studies, other clinically relevant data that might help explain our results may be unavailable. We did not evaluate possible complications associated with the use of famotidine and pantoprazole. Such information is not readily available as part of the Project Impact database. However, because of the marked similarity in all of the outcome parameters that we did evaluate (except for the incidence of UGIB), we think that the likelihood of any significant difference in the incidence of serious complications related to these agents is small.

The economic benefit of implementing practice guidelines for stress ulcer prophylaxis in the ICU has been documented.24,25 In a cost-effectiveness analysis in which cimetidine was compared with lansoprazole, Schupp et al26 concluded that although lansoprazole was a cost-effective agent for prophylaxis of stress ulcers, pantoprazole was not a cost-effective alternative to H2RAs. In a study comparing the cost-effectiveness of famotidine with that of omeprazole in preventing bleeding after endoscopic mucosal resection of a gastric mucosal neoplasm, famotidine was clinically as effective as omeprazole, with a significant cost benefit. It is not clear, however, whether these results can be extrapolated to the population of critically ill patients receiving mechanical ventilation.27 Although the outpatient price of PPIs is significantly higher than that of H2RAs, institutional costs are more complex. Acquisition costs are affected by factors such as contracts with suppliers, and overall costs are affected by factors such as storage and administrative costs in addition to the cost of the medication itself, making comparisons that can be generalized to all hospitals difficult if not impossible.


   Conclusions
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 Methods
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 Discussion
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References
 
Our data suggest that in a diverse population of critically ill patients receiving mechanical ventilation, PPIs offer no advantage over H2RAs in preventing UGIB. Indeed, in this study, the incidence of bleeding was significantly lower in the group that received an H2RA, with no identifiable difference in other outcome parameters. A larger prospective trial would be useful for confirming these findings. A comparison of these 2 classes of drugs in patients with other risk factors for UGIB, notably coagulopathy, also may be useful. In the absence of convincing data supporting the use of a specific agent or class of agents, other factors such as cost, ease of administration, adverse effects, and potential drug interactions should play an important role in choosing a therapy.

To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Phone, (800) 809-2273 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints{at}aacn.org.

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FINANCIAL DISCLOSURES
None reported.


   REFERENCES
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