Argatroban Therapy Of Hit A Overview of Studies

The efficacy and safety of argatroban therapy in patients with clinically diagnosed HIT has been evaluated in the following prospective, multicenter, open-label studies:

• ARG-911, a historical controlled study

• ARG-915, a follow-on study that also used the historical control group from ARG-911 as comparator

• ARG-915X, a Phase III extension of study ARG-915 that allowed physicians continued access to argatroban while it was under regulatory review.

Study ARG-911 has been reported in full (Lewis et al., 2001). Topline data from study ARG-915 (without its extension) as well as safety summaries from ARG-911 plus ARG-915 appear in the product's labeling information (Argatroban Prescribing Information, U.S., 2002). Outcomes of patients with acute HIT from study ARG-915 plus its extension, together simply referred to as "Argatroban-915," have also been reported in full (Lewis et al., 2003). Across these studies, 754 patients received argatroban therapy on 809 separate occasions (Lewis et al., 2000).

When these studies were conducted between 1995 and 1998, no approved alternative agent was available for use as an active comparator, and a randomized, placebo-controlled design was deemed unethical; thus, historical controls were used for comparison. The studies were similar in design with regard to objectives, inclusion and exclusion criteria, the argatroban dosing regimen, and assessments. In each study, patients were assigned at enrollment to one of two prospectively defined study arms: HIT (with isolated thrombocytopenia) or HIT with thrombosis (also referred to as "HIT with thrombosis syndrome" or "HITTS"). The overall study design is presented in Figure 4.

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