DESIR-ABLE, a multicenter, open-label, single-arm study of desirudin (Revasc®, Iprivask®) demonstrated the clinical utility and safety profile of desirudin for prevention of dangerous blood clots in a broad population of surgical and medically ill patients.
Results of the study, entitled Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE), were published in Clinical and Applied Thrombosis and Hemostasis.
“This study adds to our overall body of knowledge of desirudin, which has been shown to be safe and effective in preventing blood clots after total hip replacement surgery,” commented Jerrold Levy, MD, Professor and Deputy Chair for Research at Emory University and Chair of the DESIR-ABLE Steering Committee. “The safety profile of desirudin appears to be acceptable in many patients requiring deep vein thrombosis (DVT) prophylaxis who may not be good candidates for heparin-based anticoagulation due to low platelet counts, renal impairment or other high risk features.”
“As we have seen time and time again, despite the many treatment options to prevent blood clots in hospitalized patients, large groups of patients remain underserved,” said Dawn Bell, PharmD, Senior Vice President and General Manager of Canyon Pharmaceuticals, desirudin’s manufacturer. “The DESIR-ABLE study provides important information about the safety of desirudin in a population of patients at high risk for complications from standard drugs used for DVT prophylaxis.” Canyon provided support for the study.
Desirudin is approved in the US and Europe for the prevention of blood clots in patients undergoing hip or knee replacement surgery. It is sold under the trade name Iprivask® in the US and Revasc® in Europe. Desirudin was the first direct thrombin inhibitor (DTI) approved for DVT prophylaxis in Europe, where it has been available for over 10 years.
This was a multi-center, single-arm, open-label study of desirudin 15 mg BID in hospitalized patients requiring anticoagulation to prevent blood clots, such as a deep vein thrombosis, or DVT. The primary endpoint was major bleeding.
516 patients were enrolled at 19 centers and required anticoagulation after non-cardiac major surgery (331, 64%), cardiac surgery (45, 9%) or due to medical illness (139, 27%). The study population included many patients at high risk for bleeding or blood clots including patients with low platelet counts, morbid obesity and moderate to severe renal impairment. No patients in the study experienced a major bleed.
Canyon PharmaceuticalsTM is a privately held specialty biopharma company focused on delivering innovative therapeutic solutions that target important cellular pathways in thrombosis, tumor growth, and metastasis. Canyon holds exclusive world-wide rights to desirudin, a subcutaneous (SC) recombinant DTI, and to pegmusirudin, a pegylated recombinant DTI with a longer duration of action than desirudin.Business Wire
Last updated on: 10/10/2012