GE Healthcare and Rapidscan Pharma Solutions EU announced the launch of Rapiscan (regadenoson) in the United Kingdom, the first country in Europe to have access. Rapiscan is a new generation pharmacological stress agent for myocardial perfusion scintigraphy in adult patients unable to undergo adequate exercise stress in the diagnosis of coronary artery disease– the single most common cause of death and disability in Europe, according to the European Society of Cardiology.
Myocardial perfusion scintigraphy is a non-invasive scan of blood flow to the heart muscle. It has been appraised by the National Institute of Health and Clinical Excellence (NICE) and is found to be effective and cost-effective for the diagnosis and management of coronary artery disease.
Richard Underwood, professor of cardiac imaging at Imperial College London and the Royal Brompton Hospital, said, “We are happy that Rapiscan is now being made available in the UK and that we shall be the first in Europe to use it clinically. It provides a new option for patients who need myocardial perfusion scintigraphy either to diagnose coronary artery disease or to assess its severity and to decide upon the best treatment. It is easier to use, appears to be better tolerated, and can be used in some patients with lung problems that may complicate the use of the older agents.”
Myocardial perfusion scintigraphy provides images of blood flow to the heart muscle at rest and during exercise. Patients are commonly asked to exercise on a treadmill or bicycle and the images are created after injection of a small amount of a radioactive substance, called a radiopharmaceutical, during the exercise. Unfortunately, many myocardial perfusion scintigraphy patients are unable to exercise adequately. For these, a pharmacological stress agent, such as Rapiscan, can be used to simulate the effects of exercise by increasing coronary blood flow.
Unlike older agents, Rapiscan requires no dose adjustment for varying body weight and is administered as a 10 second injection, which cuts the need for an infusion pump, extension line and infusion line set-up. Beyond the practical benefits, Rapiscan selectively stimulates the A2A adenosine receptors responsible for the increase in blood flow, but not other adenosine receptors believed to cause undesirable effects, such as difficulty in breathing or missing heart beats, that have been associated with the existing pharmacological stress agents.
Regadenoson was FDA approved in the USA in 2008 following clinical trials of over 2,000 patients with known or suspected coronary artery disease. Today, regadenoson is currently the most widely used pharmacological stress agent in the US with several million patients having received it. In Europe, EU Commission Licence was granted by the European Medicine Agency in September 2010. In the UK and Germany, Rapiscan is distributed by GE Healthcare.