Inspra performs strongly in heart failure patients
pharmafile | May 28, 2010 | News story | Research and Development, Sales and Marketing | Inspra, Pfizer, chronic heart failure, heart failure
Pfizer is to end a clinical trial of Inspra early because of signs that it significantly cuts the risk of heart failure and heart-related deaths.
The company will stop recruiting on the recommendation of the trial’s independent Executive Steering Committee (ESC) following a second analysis by the independent Data Safety Monitoring Committee (DSMC).
Inspra is currently licensed as a treatment for patients with heart failure and left ventricular dysfunction, a very serious form of the condition experience by a small population of patients. The EMPHASIS-HF trial has been carried out in patients with mild chronic systolic heart failure, a less serious variant of the condition.
The interim analysis of the EMPHASIS-HF trial showed patients treated with Inspra (eplerenone), in addition to current standard of care, had their risk of cardiovascular death or heart failure hospitalisation significantly reduced compared with patients receiving standard of care and a placebo.
The composite primary endpoints were the first occurrence of either cardiovascular (CV) death or heart failure (HF) hospitalisation. The EMPHASIS-HF trial was to enroll around 3,100 patients and was to continue until a total of 813 adjudicated primary endpoint events were reported.
The trial results would allow Pfizer to apply for an expanded licence to treat these patients, but the company has not yet confirmed its next steps.
Professor Faiez Zannad, Inserm and University of Nancy, France, co-Chair of the Executive Steering Committee, commented: “It is not common for clinical studies to conclude early for reasons of efficacy. The EMPHASIS-HF trial had an estimated end date around October 2011 so to have met the pre-defined efficacy endpoints early is certainly a positive outcome.”
An amendment to the trial protocol will be requested to allow all patients to start treatment with eplerenone in an open label extension of the study if they so wish. Patients must first complete a close-out visit ending the double-blind placebo-controlled phase.
Andrew McConaghie
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