If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ACC: Vanlev (Omapatrilat) As Effective As Enalapril In Treatment Of Heart Failure ATLANTA, GA -- March 20, 2002 -- Preliminary clinical study results announced today demonstrate that the investigational drug Vanlev™ (omapatrilat), a novel vasopeptidase inhibitor, was as effective as the ACE-inhibitor enalapril, in the treatment of heart failure. The results of the OVERTURE (Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events) study were presented today during a Late Breaking Clinical Trial session at the 51st Annual Scientific Session of the American College of Cardiology. "Heart failure is a debilitating, often fatal disease that affects millions of people," said Milton Packer, M.D., Chairman of the OVERTURE Study Executive Committee and Professor of Medicine at the Columbia College of Physicians and Surgeons in New York. "The OVERTURE study shows that Vanlev delivers a similar magnitude of benefit as the current gold standard enalapril, in the treatment of heart failure." Enalapril has been proven to increase survival and decrease the frequency of hospitalization in patients with heart failure. In the OVERTURE study, VANLEV and enalapril produced similar treatment outcomes. Specifically, reliminary data showed that for the primary endpoint, the incidence of death or hospitalization due to worsening heart failure was 31.7 percent with Vanlev and 33.7 percent with enalapril. Both Vanlev and enalapril were generally safe and well tolerated. The incidence of angioedema, a swelling that generally affects the face, throat, lips, tongue or larynx, was 0.8 percent in Vanlev-treated patients and 0.5 percent in enalapril-treated patients. There were no cases of airway compromise. Heart failure occurs when the heart muscle becomes weak and cannot pump enough blood to meet the oxygen and nutrient requirements of the body. Heart failure patients often feel tired and weak, and experience shortness of breath. Heart failure affects between 1 and 4 percent of the world's population. In the United States alone, nearly five million people have heart failure, resulting in approximately $21.4 billion in direct healthcare costs each year including hospitalization, physician office visits, treatment and home health care. Half of the patients with heart failure will die within five years of diagnosis. OVERTURE is a randomized, double-blind, international clinical trial that was conducted in approximately 40 countries and included 5,770 patients with moderate to severe heart failure. In the study, patients were randomized to receive either Vanlev (10 mg) once-daily or enalapril (2.5 mg) twice-daily with minimum follow-up of 8 months. Dosages were increased, as tolerated, to 20 mg or 40 mg of Vanlev once-daily and 5 mg or 10 mg of enalapril twice-daily. The OVERTURE trial was sponsored by Bristol-Myers Squibb. The OVERTURE Executive Committee is made up of a panel of worldwide clinical experts and leaders in heart failure research. A panel of seven renowned cardiologists and heart-failure experts from North America, Europe, and Australia led and directed the trial and served as an advisory board for the multiple centers involved in the study. SOURCE: OVERTURE Study Executive Committee
|
