PMID- 21086085
OWN - NLM
STAT- MEDLINE
DCOM- 20110408
LR  - 20220311
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 27
IP  - 12
DP  - 2010 Dec
TI  - CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine 
      pancreatic insufficiency.
PG  - 895-916
LID - 10.1007/s12325-010-0085-7 [doi]
AB  - Exocrine pancreatic insufficiency (EPI) is associated with conditions including 
      cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic surgery (PS). The 
      symptoms include maldigestion, malnutrition, weight loss, flatulence, and 
      steatorrhea. Pancreatic enzyme replacement therapy (PERT) is the standard 
      treatment for EPI; it is regulated in many countries and most recently in the USA 
      following a US FDA mandate for all PERT manufacturers to submit new drug 
      applications. Pancrelipase delayed-release capsules (CREON(R), Abbott, Marietta, 
      GA, USA) have been available in Europe since 1984 and in the USA since 1987; a 
      new formulation was the first PERT to gain approval in the USA in 2009. The 
      efficacy and safety of CREON have been demonstrated in double-blind, randomized, 
      placebo-controlled trials in patients with CF aged >/=7 years and in patients with 
      CP or post-PS. The data consistently demonstrate significantly better fat and 
      nitrogen absorption with CREON versus placebo, and improvements in clinical 
      symptoms, stool frequency, and body weight. Additionally, efficacy and safety of 
      CREON have been shown in open-label studies in young children with CF (aged 1 
      month to 6 years), with control of fat malabsorption and control of clinical 
      symptoms. The most commonly reported adverse events (AEs) with PERT are 
      gastrointestinal disorders and allergic skin reactions. In clinical studies, 
      CREON was well tolerated with very few withdrawals due to AEs and a low frequency 
      of AEs judged treatment related, regardless of patient age. To further support 
      the known safety profile of PERT, all manufacturers are required to investigate 
      risk factors for fibrosing colonopathy, a rare gastrointestinal complication of 
      CF, and the theoretical risk of viral transmission from porcine-derived PERT 
      products. Together, the clinical study data and wealth of clinical experience 
      suggest that CREON is effective and safe in patients with EPI regardless of 
      etiology, with a very favorable risk-benefit profile.
FAU - Kuhn, Robert J
AU  - Kuhn RJ
AD  - Division of Pharmacy, Practice and Science, University of Kentucky, Lexington, 
      Kentucky 40536-0596, USA. rjkuhn1@email.uky.edu
FAU - Gelrud, Andres
AU  - Gelrud A
FAU - Munck, Anne
AU  - Munck A
FAU - Caras, Steven
AU  - Caras S
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20101115
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Gastrointestinal Agents)
RN  - 53608-75-6 (Pancrelipase)
EIN - Adv Ther. 2011 Jul;28(7):602
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Cystic Fibrosis/complications
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Enzyme Replacement Therapy/methods
MH  - Exocrine Pancreatic Insufficiency/*drug therapy/etiology
MH  - Female
MH  - Gastrointestinal Agents/*administration & dosage
MH  - Humans
MH  - Intestinal Absorption/*drug effects
MH  - Male
MH  - Middle Aged
MH  - Pancreatitis/complications
MH  - Pancrelipase/*administration & dosage
MH  - Randomized Controlled Trials as Topic
MH  - United States
EDAT- 2010/11/19 06:00
MHDA- 2011/04/09 06:00
CRDT- 2010/11/19 06:00
PHST- 2010/08/21 00:00 [received]
PHST- 2010/11/19 06:00 [entrez]
PHST- 2010/11/19 06:00 [pubmed]
PHST- 2011/04/09 06:00 [medline]
AID - 10.1007/s12325-010-0085-7 [doi]
PST - ppublish
SO  - Adv Ther. 2010 Dec;27(12):895-916. doi: 10.1007/s12325-010-0085-7. Epub 2010 Nov 
      15.