Heparin-Induced Thrombocytopenia Clinical Studies and the Efficacy of Argatroban in Japan

ABSTRACT

Immune-mediated heparin-induced thrombocytopenia (HIT) is a life-threatening side effect of heparin therapy. HIT has been better recognized in Japan since April 2006 when prescribing information on heparin was revised to include HIT. Diagnosis and treatment of HIT in Japan, however, are still problematic because Japanese regulators have not yet approved any laboratory tests or pharmacological intervention for HIT, especially in patients with acute HIT who require surgery with cardiopulmonary bypass (CPB). We report on three specific cases anticoagulated with argatroban for CPB showing the difficulty of anticoagulation management. We review several retrospective studies and a multicenter, prospective cohort study that suggest a lower incidence of HIT in Japan than what is diagnosed in Western countries. This may be due to ethnic factors and/or different clinical practices. We conducted a multicenter, nonrandomized, open-label trial showing the efficacy and safety of argatroban when carefully dosed. From this study we describe a Japanese strategy to diagnose and treat HIT that may be of value elsewhere.

KEYWORDS

Heparin-induced thrombocytopenia - Japanese population - direct thrombin inhibitor - argatroban

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