کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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5724775 | 1411505 | 2016 | 6 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Original ArticleComparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis Original ArticleComparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis](/preview/png/5724775.png)
BackgroundZenpep (APT-1008) is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).MethodsZenpep and Kreon, both containing 25,000 lipase units, were compared in a randomised, double-blind, crossover, non-inferiority study for CF-associated EPI in patients aged â¥Â 12 years. Patients on a standardised diet and stabilised treatment were randomised to two treatment sequences: Zenpep/Kreon or Kreon/Zenpep. The primary efficacy endpoint was the coefficient of fat absorption over 72 h (CFA-72 h).Results96 patients (mean age 19.2 years, 60.4% males) were randomised with 83 completers of both sequences comprising the efficacy population. Zenpep demonstrated non-inferiority and equivalence to Kreon in fat absorption (LS mean CFA-72 h: Zenpep, 84.1% [SE 1.1] vs. Kreon, 85.3% [SE 1.1]; p = 0.297). Safety and tolerability were similar.ConclusionsZenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI.NCT01641393
Journal: Journal of Cystic Fibrosis - Volume 15, Issue 5, September 2016, Pages 675-680