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International phase III trial of liprotamase efficacy and safety in pancreatic-insufficient cystic fibrosis patients  Drucy Borowitz, Christopher Stevens,

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Presentation on theme: "International phase III trial of liprotamase efficacy and safety in pancreatic-insufficient cystic fibrosis patients  Drucy Borowitz, Christopher Stevens,"— Presentation transcript:

1 International phase III trial of liprotamase efficacy and safety in pancreatic-insufficient cystic fibrosis patients  Drucy Borowitz, Christopher Stevens, Lee R. Brettman, Marilyn Campion, Barbara Chatfield, Marco Cipolli  Journal of Cystic Fibrosis  Volume 10, Issue 6, Pages (December 2011) DOI: /j.jcf Copyright © 2011 European Cystic Fibrosis Society Terms and Conditions

2 Fig. 1 The international phase III randomized withdrawal, double-blind, placebo-controlled trial of the efficacy and safety of liprotamase in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). Trial design and subject disposition. Journal of Cystic Fibrosis  , DOI: ( /j.jcf ) Copyright © 2011 European Cystic Fibrosis Society Terms and Conditions

3 Fig. 2 Mean change from baseline in coefficient of fat absorption (CFA) for CF subjects receiving liprotamase or placebo during the inpatient double-blind treatment phase of the trial, with stratification for baseline CFA, in (A) the entire intent-to-treat (ITT) population, (B) subjects who were continued from baseline on acid suppression versus subjects who did not receive acid suppression, and (C) subjects treated at US sites versus sites outside the United States. Journal of Cystic Fibrosis  , DOI: ( /j.jcf ) Copyright © 2011 European Cystic Fibrosis Society Terms and Conditions

4 Fig. 3 Adjusted mean change from baseline in coefficient of fat absorption (CFA) stratified by baseline CFA level for CF subjects receiving liprotamase or placebo during the inpatient double-blind treatment phase of the trial. Values are least square means (LSM) plus standard error (SE). Journal of Cystic Fibrosis  , DOI: ( /j.jcf ) Copyright © 2011 European Cystic Fibrosis Society Terms and Conditions


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