Comparative Trial of Canyon's Iprivask (Desirudin) with Standard of Care Shows Favorable Outcomes for Thrombosis Prophylaxis in Surgery Patients with HIT
PREVENT-HIT Study Finds Desirudin Merits Further Study; Findings Presented At Hemophilia & Thrombosis Research Society Scientific Symposium
PARSIPPANY, N.J.--(BUSINESS WIRE)--Apr 15, 2010 - Results of the first randomized, head-to-head comparison of direct thrombin inhibitors (DTIs) in patients with heparin-induced thrombocytopenia (HIT) were presented at the Hemophilia & Thrombosis Research Society 2010 Scientific Symposium in Chicago, Illinois on April 15. The PREVENT-HIT study found that desirudin warrants further investigation as an alternative treatment for thrombosis prophylaxis in surgery patients with HIT.
The study compared desirudin with argatroban, the current standard of care. In the study, no thrombosis or major bleeds occurred in patients who received desirudin, and fewer dose adjustments were required for patients receiving desirudin compared with those receiving argatroban. In addition, the cost of treatment with desirudin was about one-fifth the cost of treatment with argatroban.
Desirudin, or Iprivask®, is the first direct-thrombin inhibitor (DTI) approved in the United States by the Food and Drug Administration (FDA) for subcutaneous administration. It is approved for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism in patients undergoing elective hip replacement surgery. It had not previously been studied in patients with HIT.
PREVENT-HIT is a randomized trial comparing fixed-dose, subcutaneous (SC) desirudin with adjusted-dose, intravenous (IV) argatroban in patients with clinically suspected heparin-induced thrombocytopenia (HIT). The study concluded that the low rate of thrombotic events in a population at high risk confirms the usefulness of DTIs for patients with HIT. It also found that subcutaneous desirudin at fixed doses of 15 or 30 mg every 12 hours was effective in patients with suspected HIT. The cost of desirudin ($1,750) was about one-fifth the cost of argatroban ($8,250).
In addition, there was the need for only one dose adjustment throughout the entire trial in patients randomized to desirudin, as compared to an average of 3.8 dose adjustments per patient in subjects randomized to IV argatroban.
“HIT can be a serious clinical issue in the cardiac surgery patient,” said Steven W. Boyce, MD, Surgical Director, Heart Failure and Transplant Program, Washington Hospital Center, Washington, DC. “In our study we found that the cost and ease of administration of subcutaneous desirudin could make it an attractive alternative to IV argatroban in patients with suspected HIT. I look forward to further study of desirudin's use as a DTI for thrombosis prophylaxis.”
“We are evaluating the impact of these significant data on further desirudin investigations,” said Dawn Bell, PharmD, Senior Vice President and General Manager of Canyon Pharmaceuticals, desirudin's manufacturer. “These study results build on the potential for Iprivask to advance patient care.”
The study was a randomized, open-label, exploratory study comparing fixed-dose, SC desirudin vs. adjusted-dose, IV argatroban in 16 patients with clinically suspected HIT. Patients were randomized to desirudin 15 or 30 mg SC every 12 hours or IV argatroban in a 1:1 ratio. The primary endpoint was a composite of new or worsening thrombosis requiring discontinuation of study drug, amputation, or death from any cause. Secondary endpoints included major and minor bleeding and pharmacoeconomics. Cost of drug therapy was estimated using wholesale acquisition costs. Most patients in the study had developed HIT after vascular or cardiac surgery.
Of 16 patients randomized, heparin antibody tests were positive in 11 (nearly 70%) with similar frequency between the groups. The mean baseline platelet count was 121,000/mm3 vs. 88,000/mm3 in the argatroban and desirudin groups, respectively. The mean initial dose of argatroban was 1.6 micrograms/kilogram per minute (mcg/kg/min). Of the desirudin-treated patients, 7 of 8 received 15 mg SC every 12 hours. No patients in either group died or required amputation. One argatroban patient developed new thrombosis, but continued on argatroban therapy. No patients in the desirudin group developed thrombosis. Major bleeding occurred in 2 of 8 argatroban patients vs. 0 of 8 desirudin patients. Each group had one minor bleed. Argatroban required dose-adjustment an average of 3.8 times per patient, while desirudin was adjusted one time during the entire study (from 15 to 30 mg SC every 12 hours). The mean cost of drug therapy was $8,250 for argatroban compared with $1,750 for desirudin.
About Canyon PharmaceuticalsTM
Canyon PharmaceuticalsTM is a privately-held specialty biopharmaceuticals company focused on delivering innovative therapeutic solutions that target important cellular pathways in thrombosis and tumor growth. Canyon holds exclusive world-wide rights to desirudin, a subcutaneous (SC) recombinant direct thrombin inhibitor (DTI), and to pegmusirudin, a pegylated recombinant DTI with a longer duration of action than desirudin.
This press release contains forward-looking statements, which involve risks and uncertainties within the meaning of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ materially from the forward-looking statements discussed in this press release.
For Canyon Pharmaceuticals
Maureen Kiggins, 516-676-6774
Posted: April 2010