Cardiome up on heart failure trial success

The blinded, placebo-controlled 60-patient study, named “La Plata”, showed a statistically-significant improvement in an important measurement of cardiac function, the left ventricle ejection fraction (LVEF).

Following 28 days of oral daily dosing, LVEF increased by 6.8% relative to placebo, representing an average relative increase in cardiac output of 22.6% for the patients receiving oxypurinol.

Decreases in serum uric acid of 17.0mg/L relative to placebo were also demonstrated and improvement in the six-minute walk was seen in both treatment groups, although no statistically significant difference between the two groups was observed.

“The large physiological effect of oxypurinol demonstrated in this study further confirms our confidence in this program,” stated Dr Charles Fisher, Cardiome’s chief medical officer. “We are especially encouraged that the observed improvement compares well with existing therapeutic alternatives such as beta-blockers and cardiac re-synchronization.”

Oxypurinol is Cardiome’s lead drug in the congestive heart failure (CHF) area. In addition to the “La Plata” trial, the company is currently conducting a phase II study to test the benefit of six months of daily dosing of oxypurinol on clinical outcomes of 400 heart failure patients. The last patient was enrolled in December and results are expected to be released in the third quarter of 2005.