PMID- 21197074
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20110714
LR  - 20211020
IS  - 1687-630X (Electronic)
IS  - 1687-6121 (Print)
IS  - 1687-6121 (Linking)
VI  - 2010
DP  - 2010
TI  - Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the 
      Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic 
      Fibrosis.
PG  - 898193
LID - 10.1155/2010/898193 [doi]
LID - 898193
AB  - Background. Pancreatic enzyme replacement therapy is the standard of care for 
      treatment of malabsorption in patients with cystic fibrosis (CF) and exocrine 
      pancreatic insufficiency (PI). Aim. To evaluate efficacy and safety of a new 
      formulation of pancrelipase (Ultrase MT20) in patients with CF and PI. 
      Coefficients of fat absorption (CFA%) and nitrogen absorption (CNA%) were the 
      main efficacy parameters. Safety was evaluated by monitoring laboratory analyses, 
      adverse events (AEs), and overall signs and symptoms. Methods. Patients (n = 31) 
      were randomized in a crossover design comparing this pancrelipase with placebo 
      during 2 inpatient evaluation periods (6-7 days each). Fat and protein/nitrogen 
      ingestion and excretion were measured from food diaries and 72-hour stool 
      collections. CFA% and CNA% were calculated for each period and compared. Results. 
      Twenty-four patients provided analyzable data. This pancrelipase increased mean 
      CFA% and CNA% (+34.7% and +25.7%, resp., P < .0001 for both), reduced stool 
      frequency, and improved stool consistency compared with placebo. Placebo-treated 
      patients reported more AEs, with gastrointestinal symptoms being the most 
      frequently reported AE. Conclusions. This pancrelipase is a safe and effective 
      treatment for malabsorption associated with exocrine PI in patients with CF.
FAU - Konstan, Michael W
AU  - Konstan MW
AD  - Cystic Fibrosis Center, Rainbow Babies & Children's Hospital and Case Western 
      Reserve University School of Medicine, 11100 Euclid Avenue, Cleveland, OH 44106, 
      USA.
FAU - Liou, Theodore G
AU  - Liou TG
FAU - Strausbaugh, Steven D
AU  - Strausbaugh SD
FAU - Ahrens, Richard
AU  - Ahrens R
FAU - Kanga, Jamshed F
AU  - Kanga JF
FAU - Graff, Gavin R
AU  - Graff GR
FAU - Moffett, Kathryn
AU  - Moffett K
FAU - Millard, Susan L
AU  - Millard SL
FAU - Nasr, Samya Z
AU  - Nasr SZ
FAU - Simeon, Edith
AU  - Simeon E
FAU - Spenard, Jean
AU  - Spenard J
FAU - Grondin, Josee
AU  - Grondin J
LA  - eng
GR  - M01 RR010732/RR/NCRR NIH HHS/United States
GR  - P30 DK027651/DK/NIDDK NIH HHS/United States
GR  - M01 RR000059/RR/NCRR NIH HHS/United States
GR  - M01 RR000042/RR/NCRR NIH HHS/United States
GR  - M01 RR000064/RR/NCRR NIH HHS/United States
GR  - M01 RR000080/RR/NCRR NIH HHS/United States
PT  - Journal Article
DEP - 20101208
PL  - Egypt
TA  - Gastroenterol Res Pract
JT  - Gastroenterology research and practice
JID - 101475557
PMC - PMC3004382
EDAT- 2011/01/05 06:00
MHDA- 2011/01/05 06:01
PMCR- 2010/12/08
CRDT- 2011/01/04 06:00
PHST- 2010/09/14 00:00 [received]
PHST- 2010/10/31 00:00 [accepted]
PHST- 2011/01/04 06:00 [entrez]
PHST- 2011/01/05 06:00 [pubmed]
PHST- 2011/01/05 06:01 [medline]
PHST- 2010/12/08 00:00 [pmc-release]
AID - 10.1155/2010/898193 [doi]
PST - ppublish
SO  - Gastroenterol Res Pract. 2010;2010:898193. doi: 10.1155/2010/898193. Epub 2010 
      Dec 8.