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Randomised clinical trial: a 1‐week, double‐blind, placebo‐controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS ) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1‐year open‐label extension
Author(s) -
Seiler C. M.,
Izbicki J.,
VargaSzabó L.,
Czakó L.,
Fiók J.,
Sperti C.,
Lerch M. M.,
Pezzilli R.,
Vasileva G.,
Pap Á.,
Varga M.,
Friess H.
Publication year - 2013
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.12236
Subject(s) - medicine , placebo , gastroenterology , adverse effect , flatulence , double blind , clinical trial , surgery , pathology , alternative medicine
Summary Background Pancreatic exocrine insufficiency ( PEI ) often occurs following pancreatic surgery. Aim To demonstrate the superior efficacy of pancreatin 25 000 minimicrospheres (Creon 25000 MMS ; 9–15 capsules/day) over placebo in treating PEI after pancreatic resection. Methods A 1‐week, double‐blind, randomised, placebo‐controlled, parallel‐group, multicentre study with a 1‐year, open‐label extension ( OLE ). Subjects ≥18 years old with PEI after pancreatic resection, defined as baseline coefficient of fat absorption ( CFA ) <80%, were randomised to oral pancreatin or placebo (9–15 capsules/day: 3 with main meals, 2 with snacks). In the OLE , all subjects received pancreatin. The primary efficacy measure was least squares mean CFA change from baseline to end of double‐blind treatment ( ancova ). Results All 58 subjects randomised (32 pancreatin, 26 placebo) completed double‐blind treatment and entered the OLE ; 51 completed the OLE . The least squares mean CFA change in the double‐blind phase was significantly greater with pancreatin vs. placebo: 21.4% (95% CI : 13.7, 29.2) vs. −4.2% (−12.8, 4.5); difference 25.6% (13.9, 37.3), P < 0.001. The mean ± s.d. CFA increased from 53.6 ± 20.6% at baseline to 78.4 ± 20.7% at OLE end ( P < 0.001). Treatment‐emergent adverse events occurred in 37.5% subjects on pancreatin and 26.9% on placebo during double‐blind treatment, with flatulence being the most common (pancreatin 12.5%, placebo 7.7%). Only two subjects discontinued due to treatment‐emergent adverse events, both during the OLE . Conclusions This study demonstrates superior efficacy of pancreatin 25 000 over placebo in patients with PEI after pancreatic surgery, measured by change in CFA . Pancreatin was generally well tolerated at the high dose administered (EudraCT registration number: 2005‐004854‐29).