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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

edema and were therefore excluded from the efficacy analysis.

The estimated median time to the onset of unequivocal relief was two hours in the Cinryze group as compared with more than four hours in the placebo group (estimated success ratio 2.41; 95% CI, 1.17 to 4.95; p=0.02). The onset of unequivocal relief occurred within four hours in 21 patients in the Cinryze group and in 14 patients in the placebo group (60 percent versus 42.4 percent; p=0.062).  Median time to complete resolution was 12.3 hours in the Cinryze group and 25 hours in the placebo group (p=0.004) even though  all subjects who did not have substantial improvement by the end of the four hour post-treatment assessment period were given open label Cinryze. C1 inhibitor antigenic and functional levels increased during treatment in the group given Cinryze, but not in the group given placebo (p<0.001 for both between-group comparisons).  In contrast, C4 levels did not change significantly during the period of observation.

Safety

According to the authors, in the prophylactic treatment trial, 21 (88 percent) of subjects had one or more adverse events, the most common of which were upper respiratory tract infection, sinusitis, rash and headache. Three adverse events (pruritus and rash, lightheadedness, and fever) were classified as possibly related to the study drug. In the acute treatment trial, 6 subjects (17 percent) in the Cinryze group and 7 subjects (20 percent) in the placebo group experienced adverse events.  Three of these events were classified as potentially related to study drug (tetany in one placebo treated subject, contact dermatitis in a placebo treated subject, and injection site rash in one Cinryze treated subject).  

Open-Label Treatment Extension

After the two trials were
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SOURCE ViroPharma Incorporated
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