Safety and efficacy of pasteurized C1 inhibitor concentrate (Berinert® P) in hereditary angioedema:: a review

Background: Hereditary angioedema caused by C1 inhibitor deficiency can be life threatening. Acute exacerbations are treated with intravenous purified, pasteurized Cl esterase inhibitor concentrate at doses of 500-1000 IU. Methods: We reviewed the literature about safety and efficacy of the C1 inhibitor concentrate used in Canada (Berinert(R) P) or relevant to it. Results: Post-marketing experience since 1985 is reassuring. There were few adverse events and no transmission of infection with the pasteurized product. A number of case reports, retrospective studies and few randomized or nonrandomized prospective studies have shown good efficacy measured as clinical resolution of symptoms or in time to resolution, time to relief or time to improvement. Conclusions: There are numerous observational studies showing good efficacy and safety and a long post-marketing experience although few randomized placebo-controlled trials. (C) 2003 Elsevier Ltd. All rights reserved.