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news.Cardiome Pharma Corp has released final results from a clinical study of oxypurinol in congestive heart failure, revealing a statistically significant improvement in an important measure of cardiac function.
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The study, named EXOTIC-EF, involved intravenous dosing of 400mg of oxypurinol on a one-time basis with measurement of left-ventricle ejection fraction (LVEF) the endpoint. The study was open-label with no placebo group.
Oxypurinol administration showed an average absolute 3.5% increase in LVEF relative to pre-dosing in the 18 patients who met the entry criteria. This represents a 19.2% average relative increase in ejection fraction.
Cardiome is currently conducting a phase II study, named OPT-CHF, testing the benefit of six months of daily dosing of oxypurinol (600mg/day) on clinical outcomes of 400 heart failure patients. The last patient was enrolled in OPT-CHF in December of 2004 and results of this study are expected to be released in the third quarter of 2005.