GSK's Arixtra Shows Promise in Acutely Ill Patients
Posted on: Tuesday, 14 February 2006, 12:00 CST
A pivotal study has shown GlaxoSmithKline's antithrombotic Arixtra to be effective and well tolerated in acutely ill patients, with the treatment reducing the risk of venous thromboembolism with major bleeding risks comparable to placebo.
Results from the study, named Artemis, demonstrated that treatment with Arixtra (fondaparinux sodium) reduced patients' risk of overall venous thromboembolism (VTE) by nearly half (46.7%), with no increased risk of major bleeds compared with placebo.
The study was published in the British Medical Journal and evaluated the overall efficacy and safety of Arixtra in acutely medically ill patients aged 60 or older.
Results showed that VTE was detected in 5.6% of patients treated with Arixtra versus 10.5% of patients on placebo, demonstrating a significant reduction in relative risk. In terms of safety, meanwhile, major bleeding occurred in one patient (0.2%) in each group and minor bleeds were observed in 11 patients (2.6%) in the fondaparinux group and four (1%) in the placebo group. No patients in the fondaparinux group and five in the placebo group had fatal pulmonary embolism.
"VTE presents a significant risk to this patient population, however we have had limited understanding of the effectiveness of clot prevention to address VTE in this group," said Dr Alexander Cohen, honorary consultant vascular physician at King's College Hospital, London, UK and chairman of the study's steering committee.
"These results show that Arixtra is an effective and well tolerated treatment that can reduce the risk of VTE for these patients, further helping us to define the role of antithrombotics in this setting," he continued.
VTE is a potential risk for many acutely ill medical patients admitted to hospital. Acutely ill medical patients may be those with congestive heart failure, respiratory illness, and infectious or inflammatory disease. Each of these acute medical conditions is a strong independent risk factor for VTE, and may also cause prolonged immobilization, another risk factor.
Source: Datamonitor
Related Articles
- Lack Of Vitamin D Causes Problems For Acutely Ill Patients
- Susan Bugg Named Director of Risk Management for Risk Retention Groups Managed By Uni-Ter
- A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
- West Virginia United Health System Joins American Excess Insurance Exchange, Risk Retention Group
- New Study Demonstrated That Extending Prophylaxis With Lovenox(R) (Enoxaparin Sodium Injection) to 5 Weeks Was More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients With Reduced Mobility
- New Study Shows That Extending Prophylaxis With Clexane(R) / Lovenox(R) (Enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients With Reduced Mobility
- Largest Prospective Study of Microvolt T-Wave Alternans Demonstrates This Technology's Predictive Value for Sudden Cardiac Death in Patients With Preserved Left Ventricular Function After Acute Myocardial Infarction
- Verispan Reports: 79% of Physicians Encourage Patients to Use the Internet for Medical Information
- Dalteparin Reduced Venous Thromboembolic Events Without Increased Bleeding in Acutely Ill Medical Patients/COMMENTARY
 |
 |
User Comments (0)
RSS Feeds