Clinical Use of Lepirudin

Besides its use in patients with HIT, lepirudin has been investigated extensively in controlled clinical trials for acute coronary syndrome (ACS) (n > 14,000), including MI (Antman, 1994; Neuhaus et al., 1994) and unstable angina pectoris (Rupprecht et al., 1995; Organization to Assess Strategies for Ischemic Syndromes [OASIS-2], 1999); and in pilot studies for prophylaxis and treatment of DVT (Parent et al., 1993; Schiele et al., 1997). In patients undergoing hemodialysis (see Chapter 18) or cardiac surgery (see Chapter 19), there is observational evidence indicating safe and effective use of lepirudin. Results of three prospective clinical trials with lepirudin and an extensive postmarketing drug monitoring study in HIT patients treated in the "real-world" setting are described in the next section.

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