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Study Identifies Mortality Risk Factors in Heart Failure Patients.

TORONTO, Sept. 14 /PRNewswire/ -- Data presented today from the world's largest heart failure registry, known as ADHERE(R) (Acute Decompensated Heart Failure National Registry), identified clinical indicators that may be used to predict mortality risk in heart failure patients. These data were presented today in a poster session at the Heart Failure Society of America (HFSA) 2004 Scientific Meeting in Toronto, Canada.

The ADHERE(R) analysis evaluated hospital data from 65,180 acutely decompensated congestive heart failure patient cases to identify a combination of clinical measures that distinguished heart failure patients who were at high risk of in-hospital mortality from those at low risk. Key clinical measures identified included: blood urea nitrogen levels (BUN), systolic blood pressure (SBP), and serum creatinine (Cr).

Heart failure patients determined to have high risk of mortality were identified with blood urea nitrogen (BUN) greater than or equal to 43 mg/dL, systolic blood pressure (SBP) < 115 mm Hg, and serum creatinine (Cr) greater than or equal to 2.75 mg/dL (20.5% average mortality rate, n=1,202). Heart failure patients determined to have low risk of mortality (2.2% average mortality rate, n=41,609) were identified with BUN < 43 mg/dL and SBP greater than or equal to 115 mm Hg. Heart failure patients with intermediate risk of mortality (6.75% average mortality rate, n=22,369) had less than three of the high-risk markers and differed from the low risk group by at least one marker.

Additional differences in clinical characteristics between patients with high or low risk of mortality were also identified such as age, sex, history of coronary artery disease (CAD), history of atrial fibrillation and in-hospital procedures.

"Clearly there are clinical measures that can be used to help predict mortality risk in patients who are hospitalized with heart failure," said Clyde W. Yancy, M.D., Professor of Medicine & Cardiology, Director of Congestive Heart Failure/Heart Transplant Program at University of Texas Southwestern Medical Center, Dallas, and principal investigator of the study. "This ADHERE(R) observational study marks an important step towards determining how heart failure patients might be better triaged and cared for in-hospital, and how we might improve clinical outcomes, especially in patients at high risk for mortality."

About the ADHERE(R) Study

The ADHERE(R) analysis, "Clinical Differences Between High and Low Mortality Risk Stratified Patients Hospitalized With Acutely Decompensated Heart Failure: ADHERE(R) Registry Data," (HFSA #414), compared differences in clinical characteristics between patients classified as higher-risk and lower-risk, as previously delineated by classification and regression tree (CART) analysis. Analysis of variance (ANOVA) tests were used to compare statistical means and Chi-square tests were used to compare proportions between the high and low risk groups. The new analysis deciphered key clinical indicators of in-hospital mortality risk in these patients.

"The goal of ADHERE is to improve treatment and outcomes for acutely decompensated heart failure patients," said Gregg C. Fonarow, M.D., the Eliot Corday Chair in Cardiovascular Medicine and Science, Director of the Ahmanson-UCLA Cardiomyopathy Center and Professor of Medicine at UCLA, and co-author of the study. "This analysis marks an important step towards this goal by identifying key risk factors that may contribute to in-patient mortality."

About ADHERE(R)

ADHERE(R) is a first-of-its-kind national registry that prospectively collects observational data from across the United States in order to track and study the medical management of patients hospitalized with acute heart failure. The ADHERE(R) National Registry is sponsored by Scios Inc. and overseen by an independent scientific advisory committee of nationally recognized heart failure experts.

The ADHERE(R) Registry Core Module was launched in October 2001. It is a multicenter, observational, open-label registry of the management of patients treated in the hospital for acutely decompensated congestive heart failure (CHF). ADHERE(R) is designed to help the medical community better understand acute CHF, improve its management and enhance quality of care. Data regarding current management and treatment trends is collected from the registry and analyzed on a quarterly basis. These data and insights can be used by individual hospitals to develop guidelines and protocols and increase the use of evidence-based therapies to improve the standard of care among heart failure patients, and potentially reduce costs.

To learn more about The ADHERE(R) Registry, call 866-616-2993, or e-mail adhereinfo@sciosinc.com, or visit http://www.adhereregistry.com/.

About Decompensated Congestive Heart Failure

According to the American Heart Association Heart Disease and Stroke Statistics - 2004 Update, congestive heart failure affects more than 5 million Americans. It is estimated that the cost of treating congestive heart failure patients in the U.S. will reach $28.8 billion in 2004.

Congestive heart failure is characterized by a progressive loss in the heart's ability to pump blood. Since a weak heart does not pump fluid very well through the body, fluid can back up and "pool" in the lungs causing shortness of breath or can accumulate in the ankles causing swelling. This is why heart failure is often called "congestive" heart failure, or CHF. The term "decompensated" is a medical term used to describe patients with these symptoms.

About Scios Inc.

Scios Inc., a Johnson & Johnson company, is a biopharmaceutical company headquartered in Fremont, California. Scios is developing novel treatments for cardiovascular disease, inflammatory disease and cancer. The Company's disease-based technology platform integrates expertise in protein biology with computational and medicinal chemistry to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs. For more information, visit http://www.sciosinc.com/.

HFSA Poster #414 Tuesday, September 14, 2004

CONTACT: Chris B. Ernst of Scios Inc., +1-415-710-9445; or Karin Bauer Aranaz of WeissCom Partners, Inc., +1-415-859-3414, for Scios Inc.

Web site: http://www.adhereregistry.com/

Web site: http://www.sciosinc.com/
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Date:Sep 14, 2004
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