Vancouver, BC – September 13, 2004 – Cardiovascular drug development company Cardiome Pharma has released interim results for two physician-sponsored clinical studies for oxypurinol in congestive heart failure (CHF) patients. The results were presented at a satellite symposium to the Heart Failure Society of America’s annual meeting being held in Toronto.
The company says both studies showed a statistically significant improvement in an important measurement of cardiac function, the left ventricle ejection fraction (LVEF). The LaPlata study showed an improvement of 3.3% in LVEF relative to placebo following 28-day oral dosing of oxypurinol, while the Exotic-EF study showed a 3.6% increase in LVEF following IV dosing of oxypurinol.
The LaPlata study involves 28 days of oral dosing of oxypurinol in CHF patients, with LVEF and exercise tolerance (6 minute walk test) as endpoints. It is a blinded, placebo controlled study. Interim data covered 48 of the 60 expected subjects. Following 28 days of oral daily dosing (600 mg/day), LVEF increased by 3.3% (p less than 0.010) relative to placebo. This represents a 13.7% average increase in ejection fraction. Improvement in the 6 minute walk was seen in both treatment groups. No statistically significant difference between the two groups was observed.
“I am delighted to see the beneficial cardiac effects of oxypurinol confirmed in this study,” said Dr. Alan Moore, Cardiome’s executive vice president of clinical and regulatory affairs. “These data compare favourably to existing therapies and are especially noteworthy because in most patients the improvement was additional to these existing therapies.”
The Exotic-EF study involves intravenous dosing of 400mg of oxypurinol on a one-time basis in 20 catheterized CHF patients, with measurement of left-ventricle ejection fraction (LVEF) and cardiac oxygen consumption as endpoints. The study is open-label, with no placebo group. The reported data covered all 14 patients dosed to date. Oxypurinol administration showed a 3.6% increase (p less than 0.0032) in LVEF at 5.5 hours post-dosing relative to pre-dosing. This represents a 19.8% average increase in ejection fraction.
Prof Dr Thomas Munzel and Dr Stephan Baldus are conducting the study at the Eppendorf Clinic at the University of Hamburg.
Cardiome is also currently conducting a phase 2 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 target for completion of this placebo-controlled study is the second half of 2005. The company says it expects the last patient to be enrolled in OPT-CHF by the end this year.