Pharmacological profile of URODILATIN URODILATIN is an innovative drug with a broad spectrum of synergistic effects:

- Cardiovascular effects:	vasodilation
- Renal effects:	diuresis, natriuresis
- Pulmonary effects:	bronchodilation
- Endocrine effects:	renin, angiotensin, and aldosterone antagonism

URODILATIN reduces the workload of the heart, increases cardiac output and improves renal function by:

- Reduction of pulmonary capillary wedge pressure (PCWP) - Reduction of pulmonary artery pressure (PAP) - Reduction of systemic vascular resistance (SVR) - Reduction of venous return (RAP) - Increase of cardiac index (CI) - Increase of water and sodium excretion

URODILATIN in the treatment of decompensated CHF
URODILATIN is an innovative drug relieving patient's symptoms in decompensated CHF by improving the hemodynamic state. A Phase IIa study in patients with decompensated CHF, referred to as the SIRIUS I trial, was conducted as a double-blind, placebo-controlled ascending-dose study. This trial enrolled 24 patients who received a 24-hour infusion of placebo, or in ascending dose cohorts, 7.5, 15 or 30 ng/kg/min of URODILATIN. The study was primarily intended to assess safety, but evidence of hemodynamic activity was observed at the two higher dose levels when assessed at six hours. There was no apparent difference in adverse events across the four treatment groups. Results of the SIRIUS I study are now in press in the American Heart Journal.

A recent study, known as the SIRIUS II trial, was a randomized, double-blind, placebo-controlled clinical trial conducted at 19 centers in Europe. Primary endpoints in the study were change in pulmonary capillary wedge pressure (PCWP) and change in dyspnea (shortness of breath) score, both at six hours. A total of 221 patients were randomized equally to receive URODILATIN 7.5, 15, or 30 ng/kg/min given intravenously as a 24-hour infusion, or placebo. In the assessment of the primary endpoints, URODILATIN significantly reduced PCWP (p<0.05) and improved dyspnea score (p<0.05) in all three dose groups compared to placebo. The main adverse events through day three were dose-dependent decreases in blood pressure compared to placebo. Serum creatinine levels were unchanged during and after URODILATIN treatment when compared to placebo. The incidence of serious adverse events was similar for all three treatment groups and the placebo group.