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ViroPharma Announces Publication of Cinryze™ (C1 Esterase Inhibitor [Human]) Phase 3 Trial Results in Hereditary Angioedema (HAE) in the New England Journal of Medicine
Date:8/5/2010

t period.  All acute angioedema attacks during the study were eligible for rescue treatment with open-label Cinryze.  

The primary efficacy endpoint for each subject and for each treatment period was the number of attacks of angioedema that occurred during each period, normalized to 12 weeks.  Secondary end points, reported for each period, included average severity of attacks, average duration of attacks, the number of open-label injections of Cinryze, and the total number of days of swelling.  In addition, safety and changes from baseline in antigenic and functional levels of C1 inhibitor were evaluated.  

Twenty-four patients were enrolled in the prophylaxis trial and randomized to one of two groups, 12 to placebo and 12 to Cinryze in the first of two 12 week periods. Twenty-two of 24 subjects (11 from each randomized group) completed the first treatment period and then crossed over to the second period, and were included in the end point analyses. Although included in the analysis, 2 of these 22 analyzed subjects (one from each group) failed to complete the second 12 week period.  

The average normalized attack rates for all 22 subjects during the two 12-week crossover periods were 6.26 and 12.73 for the Cinryze and placebo treatments, respectively. The estimated average difference in attack rates between Cinryze and placebo was 6.47 (95% CI 4.21 to 8.73; p<0.001). The mean score for the severity of attacks was significantly lower during Cinryze prophylaxis than during placebo (1.3 +/- 0.85 versus 1.9 +/- 0.36, p=0.001). The total duration of attacks was also shorter with Cinryze prophylaxis compared to placebo (2.1 +/- 1.13 versus 3.4 +/- 1.39 days, p=0.002).  The number of subjects requiring open-label rescue therapy was less with Cinryze prophylaxis (11 versus 22), as was the total number of open-label injections (4.7 +/-
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SOURCE ViroPharma Incorporated
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