Lepirudin (recombinant hirudin) for parenteral anticoagulation in patients with heparin-induced thrombocytopenia. Heparin-Associated Thrombocytopenia Study (HAT) investigators.
Research article published in Circulation (1999)
Abstract
BACKGROUND: We prospectively investigated lepirudin for further parenteral anticoagulation in patients with heparin-induced thrombocytopenia (HIT). METHODS AND RESULTS: Patients with confirmed HIT (n=112) received lepirudin according to need for 2 to 10 days (longer if necessary): A1, treatment: 0.4 mg/kg IV bolus, followed by 0.15 mg. kg(-1). h(-1) intravenous infusion, n=65; A2, treatment in conjunction with thrombolysis: 0.2 mg/kg, followed by 0.10 mg. kg(-1). h(-1), n=4; and B, prophylaxis: 0.10 mg. kg(-1). h(-1), n=43. Outcomes from 95 eligible lepirudin-treated patients were compared with those of historical control patients (n=120). Complete laboratory response (activated partial thromboplastin time ratio >1.5 with </=2 dose increases and platelet count normalization by day 10) was achieved in 65 lepirudin-treated patients (69.1%; 95% CI, 59. 3% to 78.3%). At 2 weeks after cessation of lepirudin, 11 patients died (9.8%), 10 underwent limb amputation (8.9%), and 20 suffered a new thromboembolic complication (17.9%). The average combined event rate per patient-day decreased from 5.1% in the pretreatment period to 1.5% in the treatment period. Thirty-five days after HIT confirmation, fewer lepirudin-treated patients than historical control patients had experienced >/=1 outcome (cumulative incidence 30.9% versus 52.1%; relative risk [RR] 0.71; P=0.12, log-rank test). Bleeding events were more frequent in the lepirudin group than the historical control group (cumulative incidence at 35 days, 44.6% versus 27.2%; RR 2.57; P=0.0001, log-rank test). No difference was observed in bleeding events requiring transfusion (cumulative incidence at 35 days, 12.9% versus 9.1%; RR 1.66; P=0.23, log-rank test); no intracranial bleeding was observed in the lepirudin group. CONCLUSIONS: Lepirudin effectively prevents death, limb amputations, and new thromboembolic complications and has an acceptable safety profile in HIT patients. Treatment should be initiated as soon as possible if HIT is suspected.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
Lepirudin (recombinant hirudin) for parenteral anticoagulation in patients with heparin-induced thrombocytopenia. Heparin-Associated Thrombocytopenia Study (HAT) investigators.
Warum dies für die Hirudotherapie relevant ist
Diese prospektive Studie untersuchte Lepirudin (rekombinantes Hirudin) zur parenteralen Antikoagulation bei 112 Patienten mit bestätigter Heparin-induzierter Thrombozytopenie (HIT) im Vergleich zu 120 historischen Kontrollen. Lepirudin senkte die kombinierte Ereignisrate pro Patiententag von 5,1 % vor der Behandlung auf 1,5 % während der Behandlung, mit weniger kumulativen Endpunkten nach 35 Tagen im Vergleich zu den Kontrollen (30,9 % vs. 52,1 %), wobei Blutungskomplikationen in der Lepirudin-Gruppe jedoch häufiger auftraten (44,6 % vs. 27,2 %), ohne signifikanten Unterschied bei transfusionspflichtigen Blutungen und ohne intrakranielle Blutung. Diese Studie belegt den klinischen Wert eines aus Blutegeln gewonnenen Antikoagulans bei einer lebensbedrohlichen Erkrankung und ist unmittelbar relevant für das Interesse der ASH an therapeutischen Anwendungen des Blutegelsekretoms. Allerdings verwendete die Studie historische statt zeitgleicher Kontrollen und bewertete pharmazeutisches rekombinantes Hirudin, nicht jedoch eine Therapie mit lebenden Blutegeln.
Zitation
Lepirudin (recombinant hirudin) for parenteral anticoagulation in patients with heparin-induced thrombocytopenia. Heparin-Associated Thrombocytopenia Study (HAT) investigators.
Greinacher et al. · Circulation, 1999
Verwandter klinischer Kontext
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