Cardiome Reports Final Oxypurinol Clinical Results

Cardiome Pharma has released final results for the physician-sponsored "EXOTIC-EF" clinical study for oxypurinol in congestive heart failure (CHF) patients.

The 20-patient study showed a statistically significant improvement in left ventricle ejection fraction (LVEF), an important measure of cardiac function. The EXOTIC-EF (Evaluation of Xanthine Oxidase Inhibition To Improve Left VEntricular Function) study involved intravenous dosing of 400 mg of oxypurinol on a one-time basis with measurement of LVEF the endpoint. The study was open-label with no placebo group.

Oxypurinol administration showed an average absolute 3.5 percent increase in LVEF relative to predosing in the 18 patients who met the prospectively defined entry criteria. This represents a 19.2 percent average relative increase in ejection fraction.

Cardiome is currently conducting a Phase II study (called OPT-CHF) testing the benefit of six months of daily dosing of oxypurinol (600 mg/day) on clinical outcomes of 400 heart failure patients. The last patient was enrolled in OPT-CHF in December of 2004. Results of the OPT-CHF study are expected to be released in the third quarter of 2005.