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DewDiligence

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Friday, 04/07/2006 5:38:53 AM

Friday, April 07, 2006 5:38:53 AM

Post# of 252819
GSK, SNY, MNTA
Arixtra bests Lovenox in head-to-head study

[Arixtra showed non-inferiority on the compound MACE primary efficacy endpoint, statsig superior safety (less bleeding), and a statsig mortality benefit at one month and six months. All told, a clear win for GSK.]

http://biz.yahoo.com/prnews/060406/dcth009.html?.v=51

>>
ARIXTRA(R) Significantly Reduced Major Bleeding Compared to LOVENOX(R) in a Study of Patients With Acute Coronary Syndromes

Head-to-Head Data Published in New England Journal of Medicine

PHILADELPHIA, April 6 /PRNewswire-FirstCall/ -- Data published today in the New England Journal of Medicine from OASIS 5, one of the largest clinical trials ever conducted in patients with acute coronary syndromes (ACS), demonstrated that treatment with the antithrombotic medicine, ARIXTRA® (fondaparinux sodium) significantly reduced major bleeding by nearly half (48 percent) as compared to LOVENOX®* (enoxaparin) at day 9. The results showed ARIXTRA, manufactured by GlaxoSmithKline (NYSE: GSK ), demonstrated comparable efficacy to LOVENOX at day 9.

Previous studies have shown that blood thinners can substantially reduce the risk of heart attacks in patients with ACS; however, this may be accompanied by an increased risk of major bleeding. Therefore, there is a need for effective therapies in ACS with a lower incidence of major bleeding.

"These data are very encouraging," said Dr. Salim Yusuf, principal investigator of the study and professor of medicine, McMaster University and Hamilton Health Sciences, Ontario, Canada. "This patient population needs treatments that have the benefits of standard therapies while also reducing the bleeding risk."

ARIXTRA is not approved for use in any country in patients with ACS.

About the Study: Organization to Assess Strategies for Ischemic Syndromes (OASIS) 5

The OASIS 5 program is an international, randomized, double-blind, controlled study that included more than 20,000 patients at 576 sites across 41 countries. Patients in the study were randomized to receive either ARIXTRA 2.5 mg once daily up to eight days or LOVENOX 1 mg/kg twice daily for two to eight days. Study medications were administered in addition to standard medical care, such as aspirin, clopidogrel, glycoprotein IIb/IIIa inhibitors and revascularization procedures. The primary efficacy objective of the study was to evaluate whether ARIXTRA was as effective as LOVENOX in preventing death, myocardial infarction (MI) or refractory ischemia in the acute treatment of ACS patients with unstable angina or non-ST-segment elevation MI (NSTEMI). The primary safety objective was to evaluate major bleeding events up to day 9.

Unstable angina (potentially life-threatening chest pain) and acute MI (heart attack) caused by inadequate blood supply to the heart muscle are part of a complex group of cardiac diseases called ACS. NSTEMI is a type of heart attack typically caused by a severely, but not completely, blocked heart artery.

Prespecified secondary outcomes included the following: death or myocardial infarction; death, myocardial infarction, or refractory ischemia; and the individual components of these composite outcomes at 30 days and at the end of the study.

Headline Results:

ARIXTRA was as effective as LOVENOX for the primary composite endpoint of preventing death, myocardial infarction, and refractory ischemia (5.8 percent and 5.7 percent incidence, respectively) at nine days. ARIXTRA was also associated with a 48 percent (p<0.001) reduction in major bleeding versus LOVENOX (2.2 percent and 4.1 percent incidence, respectively) in this study.

The study also showed mortality rates at one month were 2.9 percent in the patient group receiving ARIXTRA and 3.5 percent in the patient group receiving LOVENOX, representing a 17 percent reduction (p=0.02) in favor of ARIXTRA. All-cause mortality rates at six months were 5.8 percent among patients receiving ARIXTRA and 6.5 percent in the LOVENOX group (p=0.05).

"New antithrombotic therapies for patients with ACS are needed, and GSK looks forward to submitting these data to regulatory agencies worldwide for review so that we may bring this important therapy to physicians and patients," said Dr. Lawson Macartney, senior vice president, Cardiovascular and Metabolic Medicine Development Center, GlaxoSmithKline.

Acute Coronary Syndromes

ACS account for about 2.5 million hospital admissions worldwide and are a major cause of mortality and morbidity in Western countries.(1) There are three main cardiac diseases that make up ACS conditions: unstable angina or chest pain, non ST-segment elevation myocardial infarction (NSTEMI), and STEMI; the latter two are also known as heart attacks.(2,3) STEMI is a severe heart attack in which there is irreversible myocardial damage as a result of insufficient blood supply to the heart muscle (or myocardial ischemia).(3)

ARIXTRA

ARIXTRA is the first in a class of antithrombotics that selectively inhibits Factor Xa, a central protein in the coagulation process. In the treatment of thrombosis, Factor Xa plays a central role in the generation of thrombin, a protein in blood that facilitates blood clotting.

For more information about ARIXTRA, please visit http://www.gsk.com.

ARIXTRA is the first selective inhibitor of Factor Xa, a protein central to the coagulation process. ARIXTRA is approved in the United States for the prevention of VTE, which includes DVT and PE, in patients undergoing surgery for hip fracture (including extended prophylaxis), knee replacement, hip replacement, and in abdominal surgery patients who are at risk for thromboembolic complications. Additionally, ARIXTRA is indicated for the treatment of acute DVT when administered in conjunction with warfarin sodium and for the treatment of acute PE when administered in conjunction with warfarin sodium, when initial therapy is administered in the hospital.
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