sniper22 schreef op 9 juli 2014 07:53:
www.haepatient.com/health-care-practi...Ruconest® provides rapid onset of symptom relief and high rates of therapeutic success in HAE patients experiencing acute attacks of angioedema (>90% of patients respond within 4 hours). 22
To date, no clinical relapses have been observed in patients treated with Ruconest® during the development programme.22
Ruconest® is effective for the treatment of angioedema attacks in all assessed anatomical locations (abdominal, oro-facial-pharyngeal-laryngeal, peripheral or urogenital sites).22
Two randomised, double-blind, placebo-controlled studies of Ruconest® have been performed. 18, 22 These investigations were conducted in Italy, Spain, Romania, the UK and Israel (the ‘European study’) and in Canada and the USA (the ‘North American study’). The studies were similar in design but differed with regard to dosing: patients in Europe were treated with 100 U/kg Ruconest® or saline placebo while those in North America received 100 U/kg or 50 U/kg Ruconest® or saline placebo. Both randomised evaluations of Ruconest® were closed to blinded treatment after interim analyses on the advice of the studies’ independent data-monitoring committees.22 These analyses revealed statistically significant differences in favour of Ruconest® for all efficacy endpoints and no apparent adverse safety findings. Results of a pooled analysis of data from the two studies are presented below. The individual results of each study were similar to those of the combined analysis. Significant reductions in the time to onset of relief of symptoms—the primary endpoint of the studies—were observed with 100 U/kg and 50 U/kg Ruconest® versus placebo (Figure 3).