Celacade, an anti-inflammatory agent, can improve outcomes for patients with moderately severe chronic heart failure, according to preliminary data from the phase III ACCLAIM trial released in advance of the full report to be presented at the World Congress of Cardiology meeting.

"While ACCLAIM was a neutral study based on the total patient population that included New York Heart Association Class II, III and IV patients, a pre-specified analysis in the subgroup of nearly 700 patients with NYHA Class II heart failure showed a powerful and very encouraging result," said James Young, MD, Chairman, Division of Medicine at the Cleveland Clinic Foundation and Chairman of the Steering Committee for the ACCLAIM trial.

"Celacade's broad-spectrum anti-inflammatory effects may be more beneficial in those patients who have not advanced to late stage disease, but who are at risk for doing so. From a healthcare system perspective, a therapy that reduces the rate of hospitalization in this large and underserved patient population would be very valuable. The therapy was also very well tolerated by patients, and in my experience, was better tolerated than many drug therapies used in heart failure. I would like to thank the investigators, my fellow Steering Committee members, the Data and Safety Monitoring Board and the Central Endpoints Committee for their diligent efforts in carrying out this very important, necessary, and well-executed study."

The double blind, placebo-controlled ACCLAIM study randomized 2,414 subjects with advanced chronic heart failure at 176 clinical centers in seven countries. The placebo (1,207 patients) and Celacade (1,207 patients) groups were balanced for all important baseline characteristics, including demographics, ejection fraction, New York Heart Association classification, concomitant medical conditions and medications, automatic implantable cardioverter defibrillators, and use of cardiac resynchronization therapy. Mean left ventricular ejection fraction was less than 30 percent.

The time to death or first cardiovascular hospitalization was not significantly different between the Celacade and placebo groups, nor was there any significant difference between treatment groups for either component of the primary endpoint.
In the pre-specified subgroup of patients with Class II chronic heart failure (692 patients), the time to death or first cardiovascular hospitalization was significantly reduced in the Celacade group compared with the placebo group by 39.1 percent.

Among secondary endpoints in the study, changes in high-sensitivity C-reactive protein were measured at baseline and 26 weeks. While changes were more favorable with Celacade, the differences did not reach statistical significance in the total population. Celacade was well tolerated in the total population, who were receiving standard-of-care medications for heart failure including diuretics, beta-blockers and angiotensin converting enzyme inhibitors.