New Sepsis Treatment Found Effective, Say Researchers Presenting at Critical Care Congress of the Society of Critical Care Medicine.

Business Editors/Health & Medical Writers

SAN ANTONIO--(BUSINESS WIRE)--Jan. 31, 2003

The first biologic treatment approved for sepsis appears be as safe and effective in clinical practice as it was during its rigorous clinical trials, according to a study released today at the 32nd Critical Care Congress of the Society of Critical Care Medicine.

"Even though the drug was administered to a slightly different population and in a slightly different manner, it was very effective and safe," says Richard R. Riker, M.D., assistant chief of the department of critical care at Maine Medical Center in Portland.

The drug, drotrecogin alfa (activated) (APC) is a genetically engineered version of a naturally occurring human protein that interferes with some of the body's harmful responses to severe infection, including the formation of blood clots that can lead to organ failure and death. Maine Medical Center was one of the sites that initially tested drotrecogin alfa (activated).

Dr. Riker, lead author of the new study, "Cutting Edge Science From the Clinical Trial to the Bedside: First Eight Months Use of Drotrecogin Alfa (Activated) for Severe Sepsis," presented the findings today at the Critical Care Congress at the Henry B. Gonzalez Convention Center in San Antonio.

During the research trials, every patient had to start the 96-hour APC infusion in the ICU and remain in the ICU for the duration of use. Also, the drug was halted two hours prior to any invasive procedure because of APC's anticoagulant properties. During this clinical study, APC was not always interrupted for invasive procedures, and patients who made rapid progress completed the infusion in a hospital room.

"Not only is APC safe and effective, no serious bleeding occurred in this cohort, even though APC infusion was not stopped for some invasive procedures," Dr. Riker comments.

Sepsis and multiple organ dysfunction syndromes are the main causes of death in the intensive care unit. Sepsis is a systemic inflammatory reaction that is often a complication of burns, surgery or illness. Patients developing sepsis progress from ill to seriously ill, onto organ dysfunction and failure (called severe sepsis) and then to septic shock. APC offers new hope in sepsis treatment.

For this study, the researchers reviewed charts from 21 consecutive patients who received APC during the eight months immediately following formulary approval to compare the Maine Medical Center experience in the clinical arena with that of the tightly controlled research trial.

The FDA approved the drug for a subset of critically ill patients as defined by an acute physiology and chronic health evaluation (APACHE II) score greater then 25. Maine Medical Center approved APC use for septic patients with shock or failure of two or more organ systems, regardless of APACHE II score.

"The vast majority of our 21 patients (86 percent) had an APACHE II score of less than 25 and yet they were a critically ill group. The majority had multi-organ system failure and septic shock, and the 28-day mortality rate was 33 percent," Dr. Riker explains. "Using APACHE II may not identify a 'low risk' group, and may unfairly exclude patients who could benefit from this drug."

Dr. Riker notes that the next challenge to intensivists will be to set the parameters for determining which patients should receive APC.

Health officials estimate that 750,000 people get sepsis in the United States each year. Of that, an estimated 30 percent will die from it, despite treatment with intravenous antibiotics and supportive care.

The Society of Critical Care Medicine is the leading professional organization dedicated to ensuring excellence and consistency in the practice of critical care medicine. With over 10,000 members worldwide, the Society is the only professional organization devoted exclusively to the advancement of multidisciplinary, multiprofessional intensive care through excellence in patient care, professional education, public education, research and advocacy. Members of the Society include intensivists, critical care nurses, critical care pharmacists, clinical pharmacologists, respiratory care practitioners and other professionals with an interest in critical care, which may include physician assistants, social workers, dieticians, and members of the clergy.