A randomized, open-label pilot study comparing desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis: PREVENT-HIT Study.

Abstract

Because of an extreme risk for thromboemboli, patients with suspected heparin-induced thrombocytopenia (HIT) require immediate initiation of an alternative anticoagulant. The only therapies approved by the Food and Drug Administration require intravenous infusion of expensive direct thrombin inhibitors. This prospective, randomized, open-label, exploratory study compared the clinical and economic utility of subcutaneous desirudin vs argatroban, the most frequently used agent for suspected or immunologically confirmed HIT, with or without thrombosis. Sixteen patients were randomized to treatment with fixed-dose desirudin (15 or 30 mg) every 12 hours or activated partial thromboplastin time-adjusted argatroban by intravenous infusion. Arm A included 8 patients naive to direct thrombin inhibitor therapy, whereas Arm B included 8 patients on argatroban for at least 24 hours before randomization. The primary efficacy measure was the composite of new or worsening thrombosis (objectively documented), amputation, or death. Other end points included major and minor bleeding while on drug therapy, time to platelet count recovery, and pharmacoeconomics. No amputations or deaths occurred. One patient randomized to argatroban had worsening of an existing thrombosis. Major bleeding occurred in 2 patients on argatroban and in none during desirudin treatment. There was 1 minor bleed in each treatment group. The average medication cost per course of treatment was $1688 for desirudin and $8250 for argatroban. Desirudin warrants further study as a potentially cost-effective alternative to argatroban in patients with suspected HIT.

• Authors: Steven W Boyce, Dennis F Bandyk, John R Bartholomew, James N Frame, Lawrence Rice
• Journal: American journal of therapeutics (Am J Ther) Vol. 18 Issue 1 Pg. 14-22 (Jan 2011) ISSN: 1536-3686 [Electronic] United States
• PMID: 21079512 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Hirudins
• Pipecolic Acids
• Recombinant Proteins
• Sulfonamides
• Heparin
• Arginine
• Thrombin
• argatroban
• desirudin

Topics

• Adolescent
• Adult
• Aged
• Anticoagulants (adverse effects, economics, therapeutic use)
• Arginine (analogs & derivatives)
• Disease Progression
• Female
• Hemorrhage (etiology)
• Heparin (adverse effects)
• Hirudins (adverse effects, economics)
• Humans
• Male
• Middle Aged
• Pilot Projects
• Pipecolic Acids (adverse effects, economics, therapeutic use)
• Platelet Count
• Postoperative Complications (prevention & control)
• Postoperative Period
• Recombinant Proteins (adverse effects, economics, therapeutic use)
• Sulfonamides
• Thrombin (antagonists & inhibitors)
• Thrombocytopenia (blood, chemically induced, drug therapy)
• Thrombosis (complications, drug therapy, etiology)
• Treatment Outcome
• Young Adult