NEW DATA RELEASED AT ISHLT MEETING MAY IMPACT TREATMENT FOR PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION
PRAGUE, Czech Republic, April 19, 2012 – An initial report from the EPITOME-1 (Epoprostenol for Injection in Pulmonary Arterial Hypertension) study of a new formulation of the drug therapy epoprostenol, marketed as Flolan® will be revealed today at the International Society for Heart and Lung Transplantation (ISHLT) 32nd Annual Meeting and Scientific Sessions in Prague, Czech Republic. The findings could potentially allow patients living with Pulmonary Arterial Hypertension (PAH) to avoid the need for using ice packs to prepare and store up to seven days worth of medication in the refrigerator.
This limited study of 30 patients compared the safety, tolerability and pharmacokinetics (what the body does to the drug) of Actelion Epoprostenol (Veletri®) to that of Flolan®. Flolan®is unstable after 8 hours at room temperature and requires the use of ice packs in a cold pouch to keep the drug chilled. Actelion Epoprostenol has increased room temperature stability. This new thermostable formulation would allow patients more freedom in their daily drug therapy. Delivering epoprostenol at room temperature could potentially afford these patients a better quality of life while using the therapy.
PAH is abnormally high blood pressure in the arteries of the lungs. This requires the right side of the heart to work harder and can cause it to become larger, typically resulting in heart failure. PAH affects more women than men and symptoms include shortness of breath, fatigue, ankle and leg swelling, bluish color of the lips and chest pain or pressure. PAH can be difficult to diagnosis and physicians must rule out other diseases that cause similar symptoms. While there is no known cure for PAH, treatment options include medications, oxygen therapy, and depending on severity of the disease, lung transplantation. Flolan®is administered as a continuous intravenous infusion via a portable infusion pump.
“The EPITOME-1 study results could lead to improved quality of life for patients,” said Reda Girgis, Associate Professor of Medicine at the Johns Hopkins University School of Medicine, Division of Pulmonary and Critical Care Medicine. “Liberating patients from the need to use ice packs and allowing them to prepare and keep medication for a longer period will be a benefit to effectively treating PAH while reducing the burdens of intravenous therapy.”
THE REVEAL RISK SCORE CALCULATOR IN NEWLY DIAGNOSED PAH PATIENTS
For patients with PAH, several predictive variables can be important for determining the response to therapy. A study of the REVEAL (Registry to Evaluate Early And Long-term) risk score for patients with PAH will be presented today at the ISHLT meeting.
Results indicate that changes in serial measurements of the REVEAL simplified risk score during one year of therapy can accurately assess survival during the subsequent year. This data will be useful in predicting the course of disease and selecting high risk patients for more aggressive therapy.
The International Society for Heart and Lung Transplantation (ISHLT) is a not-for-profit professional organization with more than 2,700 members from over 45 countries dedicated to improving the care of patients with advanced heart or lung disease through transplantation, mechanical support and innovative therapies via research, education and advocacy. For more information, visit www.ishlt.org .
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Contact: Stephen Chavez