Safety Outcomes

The cumulative incidence of major bleeding was higher in the lepirudin group than in the control group (14.9% vs. 6.7%; p = 0.064). The mean treatment duration was 14.2 days corresponding to a risk for major bleeding of 1.05% per patient day.

In a previous meta-analysis of HAT-1 and -2 patients (Greinacher et al., 2000), one of the more important points to emerge was the relationship of aPTT ratios with lepirudin safety and efficacy. For low aPTT ratios (<1.5), the incidence of the combined endpoint was not significantly reduced compared to the control (RR = 0.86; 95% CI, 0.38-1.94; P = 0.72). In addition, the risk of bleeding was not significantly greater in the lepirudin group than in the control group (RR = 1.57; 95% CI, 0.52-4.72; P = 0.42). At medium aPTT ratios (1.5-2.5), efficacy was significantly greater for the lepirudin-treated patients than for the controls (RR = 0.42; 95% CI, 0.22-0.80; P = 0.009), but there was also an increased risk of bleeding (RR = 3.21; 95% CI, 1.72-6.02; P = 0.0003). At higher aPTT ratios (>2.5), the efficacy of lepirudin was not enhanced compared with medium aPTT ratios (RR = 0.70; 95% CI, 0.21-2.32; P = 0.56). However, there was a marked increase in bleedings with high aPTT ratios (RR = 6.03; 95% CI, 2.34-15.54; P = 0.0002).

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