Abstract | BACKGROUND: OBJECTIVES: METHODS: Plasma from either healthy volunteers (n=20) or from patients (n=10) suffering from unstable angina pectoris (UAP) was spiked with increasing PEG-hirudin concentrations. In a prospective randomized clinical trial patients with UAP were treated with intravenous PEG-hirudin or heparin over 72 hours. Patients were randomized to the following treatment groups: (1) heparin control group, n=15; (2) PEG-hirudin low dose (0.1 mg/kg bolus, 0.01 mg/kg/h infusion), n=19; (3) intermediate dose (0.15 mg/kg and 0.015 mg/kg/h), n=17; 4) high-dose (0.2 mg/kg and 0.02 mg/kg/h), n=16. Spiked plasma samples and plasma from UAP patients treated with i.v. PEG-hirudin were analyzed for aPTT, ECT, and PEG-hirudin levels. RESULTS: A linear correlation up to the highest therapeutic concentrations could be observed between PEG-hirudin plasma concentrations and the ECT. This was true for both plasma samples spiked with PEG-hirudin in vitro as well as for samples taken from patients treated with i.v. PEG-hirudin (correlation coefficient 0.9, respect.) In contrast the aPTT did not show a reliable linear correlation to PEG-hirudin concentrations. CONCLUSION: Monitoring of PEG-hirudin therapy by ECT may help to avoid inadequate anticoagulation or overdosing. Thus, the safety and efficacy profile of PEG-hirudin therapy is likely to be enhanced by ECT monitoring.
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Authors | M Moser, J Ruef, K Peter, B Kohler, D C Gulba, N Paterna, T Nordt, W Kübler, C Bode |
Journal | Journal of thrombosis and thrombolysis
(J Thromb Thrombolysis)
Vol. 12
Issue 2
Pg. 165-9
(Oct 2001)
ISSN: 0929-5305 [Print] Netherlands |
PMID | 11729368
(Publication Type: Clinical Trial, Evaluation Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antithrombins
- Fibrinolytic Agents
- Hirudins
- polyethyleneglycol-hirudin
- Endopeptidases
- ecarin
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Topics |
- Angina, Unstable
(blood, drug therapy)
- Antithrombins
(analysis, pharmacokinetics, therapeutic use)
- Blood Coagulation Tests
(methods, standards)
- Drug Monitoring
(methods, standards)
- Endopeptidases
- Fibrinolytic Agents
- Hirudin Therapy
- Hirudins
(analogs & derivatives, blood, pharmacokinetics)
- Humans
- Partial Thromboplastin Time
- Regression Analysis
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