Liprotamase Long‐term Safety and Support of Nutritional Status in Pancreatic‐insufficient Cystic Fibrosis
ABSTRACT Objectives: Patients with cystic fibrosis (CF) who have exocrine pancreatic insufficiency (EPI) require treatment with pancreatic enzyme replacement therapy (PERT) to maintain adequate nutrition and age‐appropriate growth and weight gain. Liprotamase, a nonporcine, highly purified biotechno...
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| Veröffentlicht in: | Journal of pediatric gastroenterology and nutrition 2012-02, Vol.54 (2), p.248-257 |
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| container_title | Journal of pediatric gastroenterology and nutrition |
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| creator | Borowitz, Drucy Stevens, Christopher Brettman, Lee R. Campion, Marilyn Wilschanski, Michael Thompson, Henry |
| description | ABSTRACT
Objectives:
Patients with cystic fibrosis (CF) who have exocrine pancreatic insufficiency (EPI) require treatment with pancreatic enzyme replacement therapy (PERT) to maintain adequate nutrition and age‐appropriate growth and weight gain. Liprotamase, a nonporcine, highly purified biotechnology‐derived PERT, has demonstrated significant efficacy in fat and protein malabsorption in patients with EPI compared to placebo. This study of liprotamase is the first ever long‐term trial of a PERT to evaluate safety and nutritional parameters.
Methods:
This phase III 12‐month open‐label trial assessed the safety, tolerability, and long‐term nutritional effects of liprotamase treatment in patients with CF and EPI 7 years and older. All of the patients were required to discontinue their long‐term use of porcine PERTs at the time of enrollment. Dosing started at 1 capsule of liprotamase (32,500 US Pharmacopoeia (USP) units crystallized cross‐linked lipase, 25,000 USP units crystallized protease, and 3,750 USP units amorphous amylase) per meal or snack; dose could be increased based on protocol‐defined parameters.
Results:
A total of 215 subjects were enrolled and 214 received at least 1 dose of liprotamase (mean 5.5 capsules per day). During the study period, height, weight, and body mass index z scores and lung function as measured by forced expiratory volume in 1 second were stable. There were no clinically meaningful changes in laboratory tests, including levels of fat‐soluble vitamins. Liprotamase was well tolerated without any significant safety concerns. Adverse events, primarily gastrointestinal, led to treatment discontinuation for 36 subjects (16.8%), most within the first 3 months.
Conclusions:
Treatment with a mean of 5.5 capsules of liprotamase per day, during meals and snacks, for up to 12 months was safe, well tolerated, and associated with age‐appropriate growth and weight gain or weight maintenance in subjects with CF‐related EPI. |
| doi_str_mv | 10.1097/MPG.0b013e31823315d1 |
| format | Article |
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Objectives:
Patients with cystic fibrosis (CF) who have exocrine pancreatic insufficiency (EPI) require treatment with pancreatic enzyme replacement therapy (PERT) to maintain adequate nutrition and age‐appropriate growth and weight gain. Liprotamase, a nonporcine, highly purified biotechnology‐derived PERT, has demonstrated significant efficacy in fat and protein malabsorption in patients with EPI compared to placebo. This study of liprotamase is the first ever long‐term trial of a PERT to evaluate safety and nutritional parameters.
Methods:
This phase III 12‐month open‐label trial assessed the safety, tolerability, and long‐term nutritional effects of liprotamase treatment in patients with CF and EPI 7 years and older. All of the patients were required to discontinue their long‐term use of porcine PERTs at the time of enrollment. Dosing started at 1 capsule of liprotamase (32,500 US Pharmacopoeia (USP) units crystallized cross‐linked lipase, 25,000 USP units crystallized protease, and 3,750 USP units amorphous amylase) per meal or snack; dose could be increased based on protocol‐defined parameters.
Results:
A total of 215 subjects were enrolled and 214 received at least 1 dose of liprotamase (mean 5.5 capsules per day). During the study period, height, weight, and body mass index z scores and lung function as measured by forced expiratory volume in 1 second were stable. There were no clinically meaningful changes in laboratory tests, including levels of fat‐soluble vitamins. Liprotamase was well tolerated without any significant safety concerns. Adverse events, primarily gastrointestinal, led to treatment discontinuation for 36 subjects (16.8%), most within the first 3 months.
Conclusions:
Treatment with a mean of 5.5 capsules of liprotamase per day, during meals and snacks, for up to 12 months was safe, well tolerated, and associated with age‐appropriate growth and weight gain or weight maintenance in subjects with CF‐related EPI.</description><identifier>ISSN: 0277-2116</identifier><identifier>EISSN: 1536-4801</identifier><identifier>DOI: 10.1097/MPG.0b013e31823315d1</identifier><identifier>PMID: 22266487</identifier><identifier>CODEN: JPGND6</identifier><language>eng</language><publisher>Hagerstown, MD: Copyright by ESPGHAN and NASPGHAN</publisher><subject>Adolescent ; Adult ; Amylases - adverse effects ; Amylases - therapeutic use ; Biological and medical sciences ; Child ; cystic fibrosis ; Cystic Fibrosis - complications ; Drug Administration Schedule ; Enzyme Replacement Therapy - adverse effects ; Errors of metabolism ; Exocrine Pancreatic Insufficiency - drug therapy ; Exocrine Pancreatic Insufficiency - etiology ; Feeding. Feeding behavior ; Female ; Fundamental and applied biological sciences. Psychology ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Lipase - adverse effects ; Lipase - therapeutic use ; malabsorption ; Male ; Medical sciences ; Metabolic diseases ; Middle Aged ; Miscellaneous hereditary metabolic disorders ; Nutrition Assessment ; Nutritional Status ; Other diseases. Semiology ; pancreatic enzymes ; pancreatic insufficiency ; Peptide Hydrolases - adverse effects ; Peptide Hydrolases - therapeutic use ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Treatment Outcome ; Vertebrates: anatomy and physiology, studies on body, several organs or systems ; Young Adult</subject><ispartof>Journal of pediatric gastroenterology and nutrition, 2012-02, Vol.54 (2), p.248-257</ispartof><rights>2012 by European Society for European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition</rights><rights>Copyright 2012 by ESPGHAN and NASPGHAN</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4817-cba68afb90a5596ead626e9b518a6ec383b0a20090ad53dc56f17f9ecf1559893</citedby><cites>FETCH-LOGICAL-c4817-cba68afb90a5596ead626e9b518a6ec383b0a20090ad53dc56f17f9ecf1559893</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1097%2FMPG.0b013e31823315d1$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1097%2FMPG.0b013e31823315d1$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,782,786,1419,27933,27934,45583,45584</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25499307$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22266487$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Borowitz, Drucy</creatorcontrib><creatorcontrib>Stevens, Christopher</creatorcontrib><creatorcontrib>Brettman, Lee R.</creatorcontrib><creatorcontrib>Campion, Marilyn</creatorcontrib><creatorcontrib>Wilschanski, Michael</creatorcontrib><creatorcontrib>Thompson, Henry</creatorcontrib><creatorcontrib>Liprotamase 767 Study Group</creatorcontrib><title>Liprotamase Long‐term Safety and Support of Nutritional Status in Pancreatic‐insufficient Cystic Fibrosis</title><title>Journal of pediatric gastroenterology and nutrition</title><addtitle>J Pediatr Gastroenterol Nutr</addtitle><description>ABSTRACT
Objectives:
Patients with cystic fibrosis (CF) who have exocrine pancreatic insufficiency (EPI) require treatment with pancreatic enzyme replacement therapy (PERT) to maintain adequate nutrition and age‐appropriate growth and weight gain. Liprotamase, a nonporcine, highly purified biotechnology‐derived PERT, has demonstrated significant efficacy in fat and protein malabsorption in patients with EPI compared to placebo. This study of liprotamase is the first ever long‐term trial of a PERT to evaluate safety and nutritional parameters.
Methods:
This phase III 12‐month open‐label trial assessed the safety, tolerability, and long‐term nutritional effects of liprotamase treatment in patients with CF and EPI 7 years and older. All of the patients were required to discontinue their long‐term use of porcine PERTs at the time of enrollment. Dosing started at 1 capsule of liprotamase (32,500 US Pharmacopoeia (USP) units crystallized cross‐linked lipase, 25,000 USP units crystallized protease, and 3,750 USP units amorphous amylase) per meal or snack; dose could be increased based on protocol‐defined parameters.
Results:
A total of 215 subjects were enrolled and 214 received at least 1 dose of liprotamase (mean 5.5 capsules per day). During the study period, height, weight, and body mass index z scores and lung function as measured by forced expiratory volume in 1 second were stable. There were no clinically meaningful changes in laboratory tests, including levels of fat‐soluble vitamins. Liprotamase was well tolerated without any significant safety concerns. Adverse events, primarily gastrointestinal, led to treatment discontinuation for 36 subjects (16.8%), most within the first 3 months.
Conclusions:
Treatment with a mean of 5.5 capsules of liprotamase per day, during meals and snacks, for up to 12 months was safe, well tolerated, and associated with age‐appropriate growth and weight gain or weight maintenance in subjects with CF‐related EPI.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Amylases - adverse effects</subject><subject>Amylases - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>cystic fibrosis</subject><subject>Cystic Fibrosis - complications</subject><subject>Drug Administration Schedule</subject><subject>Enzyme Replacement Therapy - adverse effects</subject><subject>Errors of metabolism</subject><subject>Exocrine Pancreatic Insufficiency - drug therapy</subject><subject>Exocrine Pancreatic Insufficiency - etiology</subject><subject>Feeding. Feeding behavior</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Lipase - adverse effects</subject><subject>Lipase - therapeutic use</subject><subject>malabsorption</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Metabolic diseases</subject><subject>Middle Aged</subject><subject>Miscellaneous hereditary metabolic disorders</subject><subject>Nutrition Assessment</subject><subject>Nutritional Status</subject><subject>Other diseases. Semiology</subject><subject>pancreatic enzymes</subject><subject>pancreatic insufficiency</subject><subject>Peptide Hydrolases - adverse effects</subject><subject>Peptide Hydrolases - therapeutic use</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Treatment Outcome</subject><subject>Vertebrates: anatomy and physiology, studies on body, several organs or systems</subject><subject>Young Adult</subject><issn>0277-2116</issn><issn>1536-4801</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkc9u1DAQhy0EokvhDRDyBXFKGduxEx84wIotrbZlpYVzNHFsasifre2o2huPwDPyJLjqQqWeOFiW7O_nmflMyEsGJwx09fZic3oCLTBhBau5EEx27BFZMClUUdbAHpMF8KoqOGPqiDyL8TsAVKWEp-SIc65UWVcLMqz9LkwJB4yWrqfx2--fv5INA92is2lPcezodt7tppDo5OjlnIJPfhqxp9uEaY7Uj3SDowkWkzc57cc4O-eNt2Oiy33Mp3Tl2zBFH5-TJw77aF8c9mPydfXxy_JTsf58erZ8vy5MWbOqMC2qGl2rAaXUymKnuLK6laxGZY2oRQvIAfJ9J0VnpHKsctoaxzJfa3FM3ty9m2e7nm1MzeCjsX2Po53m2GgutNRcQSbLO9LkBmOwrtkFP2DYNwyaW89N9tw89Jxjrw4F5naw3b_QX7EZeH0AMBrsXciKfLznZKm1gOq-_s3UZ-_xRz_f2NBcWezTVZN_DCSrVMGBccgTQ5EXu429O8R8b_f_1XNzvrkUH1agIB_8AZScq7o</recordid><startdate>201202</startdate><enddate>201202</enddate><creator>Borowitz, Drucy</creator><creator>Stevens, Christopher</creator><creator>Brettman, Lee R.</creator><creator>Campion, Marilyn</creator><creator>Wilschanski, Michael</creator><creator>Thompson, Henry</creator><general>Copyright by ESPGHAN and NASPGHAN</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201202</creationdate><title>Liprotamase Long‐term Safety and Support of Nutritional Status in Pancreatic‐insufficient Cystic Fibrosis</title><author>Borowitz, Drucy ; Stevens, Christopher ; Brettman, Lee R. ; Campion, Marilyn ; Wilschanski, Michael ; Thompson, Henry</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4817-cba68afb90a5596ead626e9b518a6ec383b0a20090ad53dc56f17f9ecf1559893</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Amylases - adverse effects</topic><topic>Amylases - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>cystic fibrosis</topic><topic>Cystic Fibrosis - complications</topic><topic>Drug Administration Schedule</topic><topic>Enzyme Replacement Therapy - adverse effects</topic><topic>Errors of metabolism</topic><topic>Exocrine Pancreatic Insufficiency - drug therapy</topic><topic>Exocrine Pancreatic Insufficiency - etiology</topic><topic>Feeding. Feeding behavior</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Lipase - adverse effects</topic><topic>Lipase - therapeutic use</topic><topic>malabsorption</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Metabolic diseases</topic><topic>Middle Aged</topic><topic>Miscellaneous hereditary metabolic disorders</topic><topic>Nutrition Assessment</topic><topic>Nutritional Status</topic><topic>Other diseases. Semiology</topic><topic>pancreatic enzymes</topic><topic>pancreatic insufficiency</topic><topic>Peptide Hydrolases - adverse effects</topic><topic>Peptide Hydrolases - therapeutic use</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Treatment Outcome</topic><topic>Vertebrates: anatomy and physiology, studies on body, several organs or systems</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Borowitz, Drucy</creatorcontrib><creatorcontrib>Stevens, Christopher</creatorcontrib><creatorcontrib>Brettman, Lee R.</creatorcontrib><creatorcontrib>Campion, Marilyn</creatorcontrib><creatorcontrib>Wilschanski, Michael</creatorcontrib><creatorcontrib>Thompson, Henry</creatorcontrib><creatorcontrib>Liprotamase 767 Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of pediatric gastroenterology and nutrition</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Borowitz, Drucy</au><au>Stevens, Christopher</au><au>Brettman, Lee R.</au><au>Campion, Marilyn</au><au>Wilschanski, Michael</au><au>Thompson, Henry</au><aucorp>Liprotamase 767 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liprotamase Long‐term Safety and Support of Nutritional Status in Pancreatic‐insufficient Cystic Fibrosis</atitle><jtitle>Journal of pediatric gastroenterology and nutrition</jtitle><addtitle>J Pediatr Gastroenterol Nutr</addtitle><date>2012-02</date><risdate>2012</risdate><volume>54</volume><issue>2</issue><spage>248</spage><epage>257</epage><pages>248-257</pages><issn>0277-2116</issn><eissn>1536-4801</eissn><coden>JPGND6</coden><abstract>ABSTRACT
Objectives:
Patients with cystic fibrosis (CF) who have exocrine pancreatic insufficiency (EPI) require treatment with pancreatic enzyme replacement therapy (PERT) to maintain adequate nutrition and age‐appropriate growth and weight gain. Liprotamase, a nonporcine, highly purified biotechnology‐derived PERT, has demonstrated significant efficacy in fat and protein malabsorption in patients with EPI compared to placebo. This study of liprotamase is the first ever long‐term trial of a PERT to evaluate safety and nutritional parameters.
Methods:
This phase III 12‐month open‐label trial assessed the safety, tolerability, and long‐term nutritional effects of liprotamase treatment in patients with CF and EPI 7 years and older. All of the patients were required to discontinue their long‐term use of porcine PERTs at the time of enrollment. Dosing started at 1 capsule of liprotamase (32,500 US Pharmacopoeia (USP) units crystallized cross‐linked lipase, 25,000 USP units crystallized protease, and 3,750 USP units amorphous amylase) per meal or snack; dose could be increased based on protocol‐defined parameters.
Results:
A total of 215 subjects were enrolled and 214 received at least 1 dose of liprotamase (mean 5.5 capsules per day). During the study period, height, weight, and body mass index z scores and lung function as measured by forced expiratory volume in 1 second were stable. There were no clinically meaningful changes in laboratory tests, including levels of fat‐soluble vitamins. Liprotamase was well tolerated without any significant safety concerns. Adverse events, primarily gastrointestinal, led to treatment discontinuation for 36 subjects (16.8%), most within the first 3 months.
Conclusions:
Treatment with a mean of 5.5 capsules of liprotamase per day, during meals and snacks, for up to 12 months was safe, well tolerated, and associated with age‐appropriate growth and weight gain or weight maintenance in subjects with CF‐related EPI.</abstract><cop>Hagerstown, MD</cop><pub>Copyright by ESPGHAN and NASPGHAN</pub><pmid>22266487</pmid><doi>10.1097/MPG.0b013e31823315d1</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of pediatric gastroenterology and nutrition, 2012-02, Vol.54 (2), p.248-257 |
| issn | 0277-2116 1536-4801 |
| language | eng |
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| source | Access via Wiley Online Library; MEDLINE; Journals@Ovid Complete |
| subjects | Adolescent Adult Amylases - adverse effects Amylases - therapeutic use Biological and medical sciences Child cystic fibrosis Cystic Fibrosis - complications Drug Administration Schedule Enzyme Replacement Therapy - adverse effects Errors of metabolism Exocrine Pancreatic Insufficiency - drug therapy Exocrine Pancreatic Insufficiency - etiology Feeding. Feeding behavior Female Fundamental and applied biological sciences. Psychology Gastroenterology. Liver. Pancreas. Abdomen Humans Lipase - adverse effects Lipase - therapeutic use malabsorption Male Medical sciences Metabolic diseases Middle Aged Miscellaneous hereditary metabolic disorders Nutrition Assessment Nutritional Status Other diseases. Semiology pancreatic enzymes pancreatic insufficiency Peptide Hydrolases - adverse effects Peptide Hydrolases - therapeutic use Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Treatment Outcome Vertebrates: anatomy and physiology, studies on body, several organs or systems Young Adult |
| title | Liprotamase Long‐term Safety and Support of Nutritional Status in Pancreatic‐insufficient Cystic Fibrosis |
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