News Release

New study shows immune-enhancing therapy reduces infections and shortens hospital stay by almost three days in critically ill

Peer-Reviewed Publication

Ruder Finn Public Relations

Findings Provide Support of Level 1 Recommendation

ANAHEIM, CA, (December 17, 1999) --- For critically ill patients who have suffered trauma, sepsis or major surgery, tube-fed (enteral) supplements specially designed to boost the immune system (immune-enhancing therapy) significantly reduce infection rates and shorten the length of hospitalization by almost three days. These are results of a new study published in the December issue of Critical Care Medicine.1

When patients suffer trauma, major surgery or sepsis (the presence of pathogenic organisms, or their toxins, in the blood or tissues), their immune systems become depressed, placing them at greater risk for wound, chest and skin infections. Such infections frequently lead to multi-organ failure and, in some cases, death. Use of a ventilator to assist breathing is also often required for critically ill patients and carries risks, such as development of pneumonia and sepsis. In fact, approximately two million Americans admitted to hospitals each year acquire infections there, with treatment costing $4.5 billion annually, according to the U.S. Centers for Disease Control and Prevention (CDC). The CDC reports that 20,000 people die each year as a direct cause of these hospital-acquired infections.2

"Any critically ill patient suitable for enteral feeding may potentially benefit from immune-enhancing enteral feeds," said Richard Beale, M.D., of the Department of Intensive Care, Guy's and St Thomas' Hospital Trust, London, UK, and co-author of the study. "Our systematic analysis further reinforces the conclusions of a recent review3 that the use of immune-enhancing formulas represents a level 1 recommendation."

Level 1 is the highest ranking, "strength of evidence" recommendation, based on a method used by the Agency for Health Care Policy Research, U.S. Dept. of Health and Human Services and coded by the American Society of Parenteral and Enteral Nutrition.4 A level 1 recommendation requires evidence obtained from a meta-analysis of multiple, randomized, controlled, clinical trials.

When patients were given immune-enhancing therapy, the results were significant reductions in episodes of infection (relative risk = 0.67, p=0.006), number of days a ventilator is required (2.6 days, p=0.4) and hospital length of stay (2.9 days, p=0.0002), as compared to patients given standard, tube-fed formulas. The benefits of immune-enhancing therapy were most pronounced in surgical patients, although present in all groups. No evidence of any detrimental effect of immune-enhancing therapy was found in the study.

About the Study The study, a meta-analysis, was a statistical examination of data from 12 randomized, controlled trials involving 1,482 patients analyzed on an intent-to-treat basis (trial patients randomized and eligible to participate regardless of duration, enteral formula and protocol success considerations). The trials, conducted at medical centers in the U.S. and Europe, compared patients receiving standard enteral nutrition with patients who received commercially available immune-enhancing therapies containing arginine and glutamine (naturally occurring amino acids), nucleotides (found in yeast), and omega-3 fatty acids (found in fish oil).

The immune-enhancing formula, Impact® (Novartis Consumer Health, Nyon, Switzerland), containing arginine, nucleotides and omega-3 fatty acids, was the therapy used in 10 of the 12 trials. All patients were fed via a tube (nasoenteric or jejunostomy).

"Our study shows that immunonutrition can make a significant contribution to reducing the number of infections and length of hospital stay in critically ill patients. This is good news for everyone concerned with care of this important patient group, and the results have significant implications for hospital critical care departments," said Dr. Beale.

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