Astellas Pharma US, Inc. today announced the commercial availability of Lexiscan (TM) (regadenoson) injection for use as a pharmacologic stress agent in radionuclide MPI.

Astellas Pharma US, Inc. today announced the commercial availability of Lexiscan™ (regadenoson) injection, an A2A adenosine receptor agonist, for use as a pharmacologic stress agent in radionuclide MPI – a test that detects and characterizes coronary artery disease – in patients unable to undergo adequate exercise stress. Lexiscan, co-developed with CV Therapeutics (NASDAQ: CVTX), is the first A2A adenosine receptor agonist shown to be safe and effective as a pharmacologic stress agent in MPI studies. The A2A adenosine receptor subtype is primarily responsible for coronary vasodilation.

"Our clinical experience shows that an increasing number of patients are requiring pharmacologic stress agents for MPI studies," said Gregory Thomas, MD, Clinical Associate Professor of Medicine and Director of Nuclear Cardiology Education at the University of California at Irvine School of Medicine. "Lexiscan will be an important option in helping to ensure proper diagnosis of coronary artery disease in these patients."

MPI tests, commonly called cardiac stress tests, identify areas of poor blood flow in the heart to determine the extent of coronary artery disease, a condition that affects 16 million Americans and is responsible for more than 450,000 deaths annually in the United States. Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform an MPI study. However, almost half of patients undergoing cardiac stress tests each year are unable to exercise adequately because of medical conditions. For these patients, a pharmacologic stress agent that temporarily increases blood flow through the coronary arteries is used to mimic the increase in coronary blood flow caused by exercise. About 7.5 to 9.3 million MPI studies were performed last year in the US.

Lexiscan Clinical Trials

In two identically designed Phase III clinical trials, Lexiscan met primary endpoints for scan agreement rates by showing with 95 per cent confidence that MPI studies conducted with Lexiscan were similar to MPI studies conducted with Adenoscan® (adenosine injection).

Lexiscan was generally well-tolerated in both Phase III studies. The most common adverse events reported in patients who received Lexiscan were shortness of breath, headache, flushing, chest discomfort, angina or ST-segment depression, dizziness and nausea.

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