>>SUNNYVALE, Calif., Jan. 3 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO - news) announced today that it has begun enrolling patients in a pilot study designed to evaluate the safety and tolerability of Natrecor® (nesiritide) when administered in an outpatient setting to patients with chronic advanced congestive heart failure (CHF) who are at high risk for hospitalization.
Natrecor is currently being used by hundreds of hospitals around the country to treat patients hospitalized with acute decompensated CHF with dypsnea (i.e. shortness of breath) at rest or with minimal activity.
``There is an unmet need for more effective outpatient treatment of advanced chronic CHF that could potentially prevent or reduce hospitalizations,'' said Darlene P. Horton, M.D., Scios' Vice President of Medical Affairs. ``Clinicians are interested in using outpatient IV therapy such as Natrecor for these symptomatic patients, so we will study the safety and efficacy of this approach, optimal patient selection, dosing and treatment duration in this setting.''
The FUSION (Management of Patients with CHF After Hospitalization with Follow Up Serial Infusions Of Natrecor) study is a multi-center, randomized, open-label pilot study that will be conducted at about 40 U.S. sites and will enroll over 200 patients. Patients will be randomized to receive either their usual long-term cardiac medications (with or without IV inotropes) or serial infusions of Natrecor in addition to their usual long-term cardiac medications (excluding IV inotropes). All treatment groups will have weekly outpatient visits, and Natrecor patients will receive infusions for at least 4 hours at each weekly visit. Patients will receive study treatment for 12 weeks. Data from the FUSION study are expected to be available in late 2002.
``As physicians use more cost-effective clinical settings to manage the most advanced patients, we believe there is a significant market opportunity for Natrecor beyond the one million patients hospitalized each year for acute CHF,'' said Richard B. Brewer, Scios' president and chief executive officer. ``We plan to further evaluate potential expansions by conducting more clinical studies like FUSION, implementing the ADHERE national CHF patient registry, and supporting single-center studies physicians conduct in their areas of interest.''<<
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