Indications -- cardiovascular Message Board

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Biotech / Medical : Indications -- cardiovascular

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To: nigel bates who wrote (98)	2/11/2005 11:26:01 AM
From: keokalani'nui	of 214

Cardiome reports oxypurinol clinical results Friday February 11, 11:00 am ET NASDAQ: CRME TSX: COM VANCOUVER, Feb. 11 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME - News; TSX: COM - News) today 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 less than 40% 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%, 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% (p(equal sign)0.017) relative to placebo in the 47 patients who met the prospectively-defined entry criteria. The 6.8% average absolute improvement over placebo represented an average relative increase in cardiac output of 22.6% for the patients receiving oxypurinol. Decreases in serum uric acid of 17.0 mg/L (p less than 0.001) relative to placebo, were also demonstrated in patients who met the entry criteria (n(equal sign)47). Improvement in the 6 minute walk was seen in both treatment groups. However no statistically significant difference between the two groups was observed. No safety concerns were noted. "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." Interim results for this study were presented at a satellite symposium to the Heart Failure Society of America's annual meeting in September 2004. 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 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.

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