WASHINGTON (dpa-AFX) - Biopharmaceutical company ViroPharma Inc. (VPHM) Tuesday presented the new data analyses from the randomized, placebo-controlled and open label clinical trials of C1 esterase inhibitor or Cinryze in patients with Hereditary Angioedema or HAE. Analyses were conducted to evaluate how the use of anabolic androgens impacted the outcome of subjects while on Cinryze. No drug interaction studies of Cinryze and AA have been conducted.
In the randomized, placebo-controlled trial, 8 of 22 subjects were using AA for prophylaxis with a mean historical attack rate of 13.88 per 12 weeks. Five of these eight patients discontinued AA use prior to randomization. Among these five, the mean number of attacks over the 12-week placebo period was 15, compared to 6.8 attacks during the Cinryze treatment period, said the firm. It added that this represents a 54.7 percent decrease in attack rate which is similar to the reduction in attack rate, that is 52 percent, from the overall study population,
In the open label study, 42 of 146 subjects were using AA for prophylaxis at screening and 23 of them discontinued AA during the study. The median number of attacks/month in subjects who discontinued AA was 3 at study entry which decreased to nil during an average of 257 days in the study while taking Cinryze, said the firm. Eight subjects continued on a stable dose of AA during open label treatment.
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