ATLANTA -- GlaxoSmithKline's ( GSK) drug Arixtra significantly reduces bleeding and deaths compared with current treatments for patients with serious heart problems, according to the results of a new clinical trial. Data presented from a trial known as Oasis 6 on Tuesday showed that Arixtra was more effective and safer than heparin in a specific group of heart attack patients. For every 1,000 patients treated with Arixtra instead of heparin, 11 deaths, eight heart attacks, two strokes and three cases of severe bleeding could be avoided, according to Dr. Salim Yusuf, the top trial investigator. The study involved more than 12,000 patients with a type of heart attack called ST-segment elevation myocardial infarction, a condition that falls under the umbrella term "acute coronary syndromes." Acute coronary syndromes include unstable angina, or chest pain, and heart attacks. Just as the Oasis 6 results were announced, data from the Oasis 5 study, which included a broader set of patients, were published in the New England Journal of Medicine. In that trial, data gathered from more than 20,000 patients showed that the incidence of major bleeding associated with the treatment of acute coronary syndromes was reduced by about half with Arixtra, thereby lowering the risk of death. Researchers leading that trial said Arixtra was just as effective and safer than the Sanofi-Aventis ( SNY) drug Lovenox, which is commonly used in patients with acute coronary syndromes. According to the study, discussed at the American College of Cardiology annual meeting in Atlanta, 22 patients on Lovenox experienced fatal bleeding. Seven patients on Arixtra died from bleeding complications. Additionally, Arixtra was shown to be more effective than Lovenox in preventing blood clots in the legs of patients undergoing orthopedic surgery, according to researchers. Doctors are especially concerned when blood clots form in the legs, because the clots can travel to the lungs and block blood flow there. Left undiagnosed, these clots are associated with a 30% risk of death.
The Arixtra studies were sponsored by Glaxo, Sanofi-Aventis and Organon, part of Akzo Nobel ( AKZOY). Arixtra was co-developed by Sanofi and Organon, and in 2004 Sanofi acquired all the rights to the drug and sold it to Glaxo. Also presented on Tuesday were Sanofi-supported trial data on Lovenox, comparing the medication with the commonly used heart drug heparin. According to the results of this trial, although Lovenox was more effective in treating a specific group of heart attack patients, it was associated with major bleeding episodes. For every 1,000 patients on Lovenox, there would be 15 fewer nonfatal repeat heart attacks and six fewer deaths, but four additional cases of nonfatal, yet major, bleeding, the study found. However, "it is our judgment that despite the increase in episodes of major bleeding, the early and sustained reduction of ischemic events and the balance of efficacy and safety" show an advantage to using Lovenox, according to lead trial investigator Dr. Elliot Antman of Harvard Medical School and his colleagues. Results of the Lovenox trial were also published in the New England Journal of Medicine.