Abstract:
BACKGROUND:Pancreatic enzyme replacement therapy (PERT) is necessary to prevent severe maldigestion and unwanted weight loss associated with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS). AIM:To assess the long-term safety and efficacy of pancrelipase (pancreatin) delayed-release capsules (Creon) in this population. METHODS:This was a 6-month, open-label extension of a 7-day, double-blind, placebo-controlled study enrolling patients ≥18 years old with confirmed EPI due to CP or PS who were previously receiving PERT. Patients received individualised pancrelipase doses as directed by investigators (administered as Creon 24 000-lipase unit capsules). RESULTS:Overall, 48 of 51 patients completed the open-label phase; one withdrew due to the unrelated treatment-emergent adverse event (TEAE) of cutaneous burns and two were lost to follow-up. The mean age was 50.9 years, 70.6% of patients were male, 76.5% had CP and 23.5% had undergone PS. The mean±s.d. pancrelipase dose was 186960±74640 lipase units/day. TEAEs were reported by 22 patients (43.1%) overall. Only four patients (7.8%) had TEAEs that were considered treatment related. From double-blind phase baseline to end of the open-label period, subjects achieved a mean±s.d. body weight increase of 2.7±3.4 kg (P<0.0001) and change in daily stool frequency of -1.0±1.3 (P<0.001). Improvements in abdominal pain, flatulence and stool consistency were observed. CONCLUSIONS:Pancrelipase was well tolerated over 6 months and resulted in statistically significant weight gain and reduced stool frequency in patients with EPI due to CP or PS previously managed with standard PERT.
journal_name
Aliment Pharmacol Therjournal_title
Alimentary pharmacology & therapeuticsauthors
Gubergrits N,Malecka-Panas E,Lehman GA,Vasileva G,Shen Y,Sander-Struckmeier S,Caras S,Whitcomb DCdoi
10.1111/j.1365-2036.2011.04631.xsubject
Has Abstractpub_date
2011-05-01 00:00:00pages
1152-61issue
10eissn
0269-2813issn
1365-2036journal_volume
33pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:Guidelines recommend that patients with gastro-oesophageal reflux disease are adequately treated with acid-suppressive therapy before undergoing anti-reflux surgery. Little is known of the use of acid-suppressive drugs before anti-reflux surgery. AIM:To determine the use of proton pump inhibitors and H2 -re...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 杂志文章,多中心研究
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
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pub_type: 杂志文章,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
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更新日期:2005-12-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
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更新日期:2018-02-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.1993.tb00095.x
更新日期:1993-06-01 00:00:00
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abstract:BACKGROUND:The approval of the tyrosine kinase inhibitor sorafenib in 2007 marked a milestone in the treatment of hepatocellular carcinoma, as sorafenib was the first systemic therapy to show a survival benefit in patients with advanced hepatocellular carcinoma. Since then many drugs failed in the first- and second-lin...
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pub_type: 杂志文章,评审
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更新日期:2018-09-01 00:00:00
abstract:BACKGROUND:Non-alcoholic fatty liver disease is prevalent in affluent countries and is a cause of cirrhosis and possibly hepatocellular carcinoma. AIM:To examine the clinical and histological features of biopsy-proven non-alcoholic fatty liver disease and investigate the predictors of severe histological disease in Ch...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.2004.02012.x
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,多中心研究
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更新日期:2012-04-01 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2004-11-01 00:00:00