Taylor C J, Thieroff-Ekerdt R, Shiff S, Magnus L, Fleming R, Gommoll C
University of Sheffield, Sheffield, UK.
Former employee of Forest Research Institute, Inc., an affiliate of Actavis, Inc., Jersey City, NJ, USA.
J Cyst Fibros. 2016 Sep;15(5):675-80. doi: 10.1016/j.jcf.2016.02.010. Epub 2016 Mar 21.
Zenpep (APT-1008) is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).
Zenpep 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 ≥12years. 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 72h (CFA-72h).
96 patients (mean age 19.2years, 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-72h: Zenpep, 84.1% [SE 1.1] vs. Kreon, 85.3% [SE 1.1]; p=0.297). Safety and tolerability were similar.
Zenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI. NCT01641393.
Zenpep（APT - 1008）是一种用于治疗与囊性纤维化（CF）相关的外分泌性胰腺功能不全（EPI）的胰腺酶产品。
在一项针对≥12岁CF相关EPI患者的随机、双盲、交叉、非劣效性研究中，对均含25,000脂肪酶单位的Zenpep和慷彼申进行了比较。接受标准化饮食和稳定治疗的患者被随机分为两个治疗序列：Zenpep/慷彼申或慷彼申/Zenpep。主要疗效终点是72小时内的脂肪吸收系数（CFA - 72h）。
96例患者（平均年龄19.2岁，60.4%为男性）被随机分组，83例完成了两个序列治疗的患者构成疗效人群。在脂肪吸收方面，Zenpep显示出与慷彼申非劣效且等效（LS平均CFA - 72h：Zenpep为84.1% [标准误1.1]，慷彼申为85.3% [标准误1.1]；p = 0.297）。安全性和耐受性相似。
在治疗CF相关EPI的青少年和成人中，Zenpep在疗效和安全性方面与慷彼申相当。NCT01641393。
