FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2010756316> ?p ?o ?g. }

• W2010756316 endingPage "452" @default.
• W2010756316 startingPage "443" @default.
• W2010756316 abstract "BackgroundMost cystic fibrosis (CF) patients have exocrine pancreatic insufficiency (EPI) and need supplementation with pancreatic enzyme replacement therapy (PERT). Liprotamase, a novel non-porcine PERT containing highly purified biotechnology-derived lipase, protease, and amylase, has successfully undergone initial efficacy and safety testing.MethodsIn this international phase III parallel-group, randomized-withdrawal, double-blind placebo-controlled trial, CF patients with EPI 7 years and older, including nutritionally and functionally compromised individuals, underwent baseline testing for coefficients of fat and nitrogen absorption (CFA and CNA) and stool weight and frequency while off PERT. After an open-label treatment period with liprotamase, subjects were randomized 1:1 to one liprotamase or placebo capsule taken with 3 meals and 2 snacks per day. The dose was fixed and increases were not allowed. The same measurements were obtained again after treatment with double-blind study drug or placebo.Results138 subjects were randomized. The adjusted least squares mean (LSM) difference between the treatment and placebo groups for change in CFA was 15.1% (p=0.001) for the subgroup with baseline CFA <40%, 8.6% (p=0.006) for subjects with baseline CFA ≥40%, and 10.6% (p<0.001) for the overall intent-to-treat population. Similar results were seen for change in CNA. Stool weight was significantly decreased although not stool frequency. Liprotamase was well tolerated with no safety concerns identified.ConclusionsIn a CF patient population reflective of that encountered in clinical practice, this trial demonstrated that liprotamase at a fixed dose of one capsule per meal or snack (5 capsules per day) was well tolerated and significantly increased fat absorption as measured by improvement in CFA, significantly increased protein absorption as measured by improvement in CNA, and significantly decreased stool weight." @default.
• W2010756316 created "2016-06-24" @default.
• W2010756316 creator A5022080579 @default.
• W2010756316 creator A5032639678 @default.
• W2010756316 creator A5034965575 @default.
• W2010756316 creator A5037721874 @default.
• W2010756316 creator A5047873331 @default.
• W2010756316 creator A5091825269 @default.
• W2010756316 date "2011-12-01" @default.
• W2010756316 modified "2023-09-25" @default.
• W2010756316 title "International phase III trial of liprotamase efficacy and safety in pancreatic-insufficient cystic fibrosis patients" @default.
• W2010756316 cites W1966079564 @default.
• W2010756316 cites W1967527234 @default.
• W2010756316 cites W1983061964 @default.
• W2010756316 cites W2000533012 @default.
• W2010756316 cites W2007795584 @default.
• W2010756316 cites W2009659008 @default.
• W2010756316 cites W2012583869 @default.
• W2010756316 cites W2031968580 @default.
• W2010756316 cites W2033160596 @default.
• W2010756316 cites W2034409392 @default.
• W2010756316 cites W2055855735 @default.
• W2010756316 cites W2058180897 @default.
• W2010756316 cites W2082570714 @default.
• W2010756316 cites W2085902602 @default.
• W2010756316 cites W2104915499 @default.
• W2010756316 cites W2115089567 @default.
• W2010756316 cites W2134956122 @default.
• W2010756316 cites W2163362995 @default.
• W2010756316 cites W2169565455 @default.
• W2010756316 cites W2170363361 @default.
• W2010756316 cites W2316982541 @default.
• W2010756316 cites W2321732675 @default.
• W2010756316 cites W2323908411 @default.
• W2010756316 cites W2325591522 @default.
• W2010756316 cites W2328674548 @default.
• W2010756316 cites W24108545 @default.
• W2010756316 doi "https://doi.org/10.1016/j.jcf.2011.07.001" @default.
• W2010756316 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/21831726" @default.
• W2010756316 hasPublicationYear "2011" @default.
• W2010756316 type Work @default.
• W2010756316 sameAs 2010756316 @default.
• W2010756316 citedByCount "27" @default.
• W2010756316 countsByYear W20107563162012 @default.
• W2010756316 countsByYear W20107563162013 @default.
• W2010756316 countsByYear W20107563162014 @default.
• W2010756316 countsByYear W20107563162015 @default.
• W2010756316 countsByYear W20107563162016 @default.
• W2010756316 countsByYear W20107563162017 @default.
• W2010756316 countsByYear W20107563162018 @default.
• W2010756316 countsByYear W20107563162019 @default.
• W2010756316 countsByYear W20107563162020 @default.
• W2010756316 countsByYear W20107563162022 @default.
• W2010756316 crossrefType "journal-article" @default.
• W2010756316 hasAuthorship W2010756316A5022080579 @default.
• W2010756316 hasAuthorship W2010756316A5032639678 @default.
• W2010756316 hasAuthorship W2010756316A5034965575 @default.
• W2010756316 hasAuthorship W2010756316A5037721874 @default.
• W2010756316 hasAuthorship W2010756316A5047873331 @default.
• W2010756316 hasAuthorship W2010756316A5091825269 @default.
• W2010756316 hasBestOaLocation W20107563161 @default.
• W2010756316 hasConcept C126322002 @default.
• W2010756316 hasConcept C142724271 @default.
• W2010756316 hasConcept C168563851 @default.
• W2010756316 hasConcept C204787440 @default.
• W2010756316 hasConcept C27081682 @default.
• W2010756316 hasConcept C2776938444 @default.
• W2010756316 hasConcept C2778778583 @default.
• W2010756316 hasConcept C2908647359 @default.
• W2010756316 hasConcept C59822182 @default.
• W2010756316 hasConcept C71924100 @default.
• W2010756316 hasConcept C86803240 @default.
• W2010756316 hasConcept C90924648 @default.
• W2010756316 hasConcept C99454951 @default.
• W2010756316 hasConceptScore W2010756316C126322002 @default.
• W2010756316 hasConceptScore W2010756316C142724271 @default.
• W2010756316 hasConceptScore W2010756316C168563851 @default.
• W2010756316 hasConceptScore W2010756316C204787440 @default.
• W2010756316 hasConceptScore W2010756316C27081682 @default.
• W2010756316 hasConceptScore W2010756316C2776938444 @default.
• W2010756316 hasConceptScore W2010756316C2778778583 @default.
• W2010756316 hasConceptScore W2010756316C2908647359 @default.
• W2010756316 hasConceptScore W2010756316C59822182 @default.
• W2010756316 hasConceptScore W2010756316C71924100 @default.
• W2010756316 hasConceptScore W2010756316C86803240 @default.
• W2010756316 hasConceptScore W2010756316C90924648 @default.
• W2010756316 hasConceptScore W2010756316C99454951 @default.
• W2010756316 hasIssue "6" @default.
• W2010756316 hasLocation W20107563161 @default.
• W2010756316 hasLocation W20107563162 @default.
• W2010756316 hasOpenAccess W2010756316 @default.
• W2010756316 hasPrimaryLocation W20107563161 @default.
• W2010756316 hasRelatedWork W2091712896 @default.
• W2010756316 hasRelatedWork W2126582176 @default.
• W2010756316 hasRelatedWork W2418502454 @default.
• W2010756316 hasRelatedWork W2802582670 @default.
• W2010756316 hasRelatedWork W3159250744 @default.
• W2010756316 hasRelatedWork W4233016836 @default.

• next