Study provides guidance for use of acid-suppressive medications in hospital patients

BOSTON -- Critically ill patients in hospital intensive care units (ICUs) are routinely prescribed acid-suppressive medications to reduce their risk of developing stress ulcers and gastrointestinal bleeding, both of which can result from being in a stressful environment and from being intubated. Over the years, this routine practice has often been extended to patients outside the ICU, despite a lack of evidence that this population is at significant risk of these complications.

Now a study led by investigators at Beth Israel Deaconess Medical Center (BIDMC) describes a new scoring system to help clinicians better identify non-ICU hospital patients who are at risk for GI bleeding. Appearing in the Journal of General Internal Medicine, the new findings could help doctors to selectively use acid-suppressive medications when needed – and avoid using them when there is no indication that patients are at risk – thereby saving costs and avoiding the medications' sometimes serious side effects.

"Current guidelines recommend against the routine use of acid-suppressive medication to prevent stress ulcers in non-ICU patients. Moreover, there is growing evidence that these drugs are associated with an increased risk of complications, including hospital-acquired pneumonia and clostridium difficile," explains first author Shoshana Herzig, MD, an investigator in BIDMC's Division of General Medicine and Primary Care and Instructor in Medicine at Harvard Medical School. "Despite these factors, acid-suppressive medications continue to be used indiscriminately in non-ICU patients."

However, she adds, eliminating their use altogether is not the answer. "It would be preferable to target use of these medications to patients who need them most. We had observed that there was a lack of evidence to guide physicians in prescribing acid-suppressive medications for stress ulcer prophylaxis in patients outside the ICU. Our goal was to provide data that might help clinicians to more appropriately prescribe these medications."

The authors examined records of 75,723 patient admissions at Beth Israel Deaconess Medical Center over a four-year period. Patients were excluded if they had been admitted to the hospital with an existing case of GI bleeding, if they developed a bleed within a day of admission or if they were scheduled to undergo cardiac catheterization, which exposes them to high levels of medications that impair clotting.

They found that gastrointestinal bleeding occurred in 203 patients over the study time-frame. The authors then used a statistical modeling technique to approximate the risk of GI bleeding associated with many different potential risk factors. "This allowed us to identify certain factors associated with significantly higher rates of bleeding," explains Herzig. "Our analysis revealed a number of independent risk factors that appeared to be associated with GI bleeds among non-ICU patients. These included being over age 60; being male; having liver disease, acute renal failure or sepsis; use of anticoagulant medication; preexisting clotting disorders; or being hospitalized on the internal medicine service.

The researchers then calculated the number of patients in each risk category that would need to be treated with acid-suppressive medication to prevent one GI bleed. "This allowed us to identify a small group of patients for whom the benefits of these medications seemed to outweigh the risks," says Herzig. "In the remaining patients, we determined that medication could be safely withheld."

While future studies will be needed to reproduce this data, adds Herzig, as a first step, the new scoring system will enable clinicians to identify the subset of patients who might benefit from prophylactic use of acid-suppressive medication, as well as a larger group for whom these medications might be safely avoided.

This study was funded, in part, by grant K24AG035075from the National Institute on Aging and grant 1 UL1 RR025758-01 from the National Center for Research Resources to support the Harvard Clinical and Translational Science Center.

Study coauthors include BIDMC investigators Edward R. Marcantonio, MD, SM (senior author), David B. Feinbloom, MD, Michael D. Howell, MD, MPH, Kalon K. L. Ho, MD, and Long H. Ngo, PhD; and Michael B. Rothberg, MD, MPH, of Baystate Medical Center and Tufts University School of Medicine.

BIDMC is a patient care, teaching and research affiliate of Harvard Medical School and currently ranks third in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org.