Cardiome Reports Oxypurinol Clinical Results

Cardiome Pharma has announced results for the physician-sponsored "La Plata" clinical study for oxypurinol in congestive heart failure (CHF) patients.

The blinded, placebo-controlled 60-patient study showed a statistically significant improvement in an important measurement of cardiac function, the left ventricle ejection fraction (LVEF). The randomized, double-blind, placebo-controlled trial involved 28 days of oral dosing of oxypurinol in CHF patients with LVEF of less than 40 percent and Class II-III CHF as rated by the New York Heart Association classification system.

The trial enrolled a total of 60 patients, of whom 47 met the entry criteria. The remaining 13 patients enrolled had LVEF exceeding 40 percent, as measured by blinded reading of echocardiograms upon completion of the study.

Following 28 days of oral daily dosing (600 mg/day), LVEF increased by 6.8 percent relative to placebo in the 47 patients who met the prospectively defined entry criteria. The 6.8 percent average absolute improvement over placebo represented an average relative increase in cardiac output of 22.6 percent for the patients receiving oxypurinol. Decreases in serum uric acid of 17 mg/L relative to placebo, were also demonstrated in patients who met the entry criteria. Improvement in the six-minute walk was seen in both treatment groups. However no statistically significant difference between the two groups was observed. No safety concerns were noted.