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A Randomized, Open-Label Pilot Study Comparing Desirudin and Argatroban in Patients With Suspected Heparin-Induced Thrombocytopenia With or Without Thrombosis: PREVENT-HIT Study
- Source :
- American Journal of Therapeutics. 18:14-22
- Publication Year :
- 2011
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2011.
-
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.
- Subjects :
- Adult
Male
Adolescent
medicine.drug_class
Hemorrhage
Pilot Projects
Arginine
Argatroban
law.invention
Young Adult
Postoperative Complications
Randomized controlled trial
law
Heparin-induced thrombocytopenia
Humans
Medicine
Pharmacology (medical)
Postoperative Period
Aged
Pharmacology
Sulfonamides
Heparin
Platelet Count
business.industry
Anticoagulant
Thrombin
Anticoagulants
Thrombosis
General Medicine
Hirudins
Middle Aged
medicine.disease
Thrombocytopenia
Recombinant Proteins
Treatment Outcome
Direct thrombin inhibitor
Pipecolic Acids
Anesthesia
Disease Progression
Female
business
Discovery and development of direct thrombin inhibitors
medicine.drug
Subjects
Details
- ISSN :
- 10752765
- Volume :
- 18
- Database :
- OpenAIRE
- Journal :
- American Journal of Therapeutics
- Accession number :
- edsair.doi.dedup.....60e12fadb5f1d85f6bbc99d22a7b8398