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Steven Caras - One of the best experts on this subject based on the ideXlab platform.

  • a 6 month open label clinical trial of pancrelipase delayed release capsules creon in patients with Exocrine Pancreatic Insufficiency due to chronic pancreatitis or Pancreatic surgery
    Alimentary Pharmacology & Therapeutics, 2011
    Co-Authors: N B Gubergrits, Suntje Sanderstruckmeier, Steven Caras, Galina Vasileva, Ewa Maleckapanas, Yannan Shen, Glen A Lehman, David C. Whitcomb
    Abstract:

    Aliment Pharmacol Ther 2011; 33: 1152–1161 Summary 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 186 960 ± 74 640 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.

  • CREON (Pancrelipase Delayed-Release Capsules) for the treatment of Exocrine Pancreatic Insufficiency
    Advances in Therapy, 2010
    Co-Authors: Robert J. Kuhn, Andres Gelrud, Anne Munck, Steven Caras
    Abstract:

    Exocrine Pancreatic Insufficiency (EPI) is associated with conditions including cystic fibrosis (CF), chronic pancreatitis (CP), and Pancreatic surgery (PS). The symptoms include maldigestion, malnutrition, weight loss, flatulence, and steatorrhea. Pancreatic enzyme replacement therapy (PERT) is the standard treatment for EPI; it is regulated in many countries and most recently in the USA following a US FDA mandate for all PERT manufacturers to submit new drug applications. Pancrelipase delayed-release capsules (CREON®, Abbott, Marietta, GA, USA) have been available in Europe since 1984 and in the USA since 1987; a new formulation was the first PERT to gain approval in the USA in 2009. The efficacy and safety of CREON have been demonstrated in double-blind, randomized, placebo-controlled trials in patients with CF aged ≥7 years and in patients with CP or post-PS. The data consistently demonstrate significantly better fat and nitrogen absorption with CREON versus placebo, and improvements in clinical symptoms, stool frequency, and body weight. Additionally, efficacy and safety of CREON have been shown in open-label studies in young children with CF (aged 1 month to 6 years), with control of fat malabsorption and control of clinical symptoms. The most commonly reported adverse events (AEs) with PERT are gastrointestinal disorders and allergic skin reactions. In clinical studies, CREON was well tolerated with very few withdrawals due to AEs and a low frequency of AEs judged treatment related, regardless of patient age. To further support the known safety profile of PERT, all manufacturers are required to investigate risk factors for fibrosing colonopathy, a rare gastrointestinal complication of CF, and the theoretical risk of viral transmission from porcine-derived PERT products. Together, the clinical study data and wealth of clinical experience suggest that CREON is effective and safe in patients with EPI regardless of etiology, with a very favorable risk-benefit profile.

  • pancrelipase delayed release capsules creon for Exocrine Pancreatic Insufficiency due to chronic pancreatitis or Pancreatic surgery a double blind randomized trial
    The American Journal of Gastroenterology, 2010
    Co-Authors: David C. Whitcomb, Suntje Sanderstruckmeier, Galina Vasileva, Ewa Maleckapanas, N B Gubergrits, Yannan Shen, Glen A Lehman, Steven Caras
    Abstract:

    Pancrelipase Delayed-Release Capsules (CREON) for Exocrine Pancreatic Insufficiency due to Chronic Pancreatitis or Pancreatic Surgery: A Double-Blind Randomized Trial

  • safety and tolerability of a new formulation of pancrelipase delayed release capsules creon in children under seven years of age with Exocrine Pancreatic Insufficiency due to cystic fibrosis an open label multicentre single treatment arm study
    Clinical Drug Investigation, 2010
    Co-Authors: Gavin R Graff, James Royall, Steven Caras, John Mcnamara, Kristin Forssmann
    Abstract:

    Background: Exocrine Pancreatic Insufficiency (EPI) is a deficiency of digestive enzymes caused by diseases such as cystic fibrosis (CF). Patients with EPI due to CF require Pancreatic enzyme replacement therapy (PERT) in order to maintain adequate nutrition. A new formulation of pancrelipase delayed-release capsules (CREON®) recently received US FDA approval and has demonstrated efficacy and safety in patients with CF aged ≥7 years.

  • efficacy and safety of creon 24 000 in subjects with Exocrine Pancreatic Insufficiency due to cystic fibrosis
    Journal of Cystic Fibrosis, 2009
    Co-Authors: Bruce C Trapnell, Katrin Beckmann, Karen Maguiness, David Boyd, Gavin R Graff, Steven Caras
    Abstract:

    Abstract Background Pancreatic enzyme replacement therapy is critical for adequate nutrition in cystic fibrosis (CF) patients with Exocrine Pancreatic Insufficiency (EPI). Methods This was a double-blind, randomised, placebo-controlled, two-period crossover study assessing efficacy and safety of Creon 24,000-unit capsules in CF subjects ≥12years with EPI. Patients were randomised to one of two 5-day sequences, Creon/placebo or placebo/Creon (target dose, 4000 lipase units/g fat). Primary outcome was the coefficient of fat absorption (CFA); secondary outcomes were coefficient of nitrogen absorption (CNA), symptoms, and safety. Results Thirty-two subjects were randomised. Mean CFA and CNA were significantly greater with Creon than placebo (CFA, 88.6% vs. 49.6%; CNA, 85.1% vs. 49.9%; p Conclusions This study demonstrated Creon was effective in treating EPI due to CF and was safe and well tolerated.

David C. Whitcomb - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and safety of pancrelipase pancreatin in patients with Exocrine Pancreatic Insufficiency and a medical history of diabetes mellitus
    Pancreas, 2016
    Co-Authors: David C. Whitcomb, Amit Bodhani, Katrin Beckmann, Suntje Sanderstruckmeier, Mahesh Fuldeore, Paul F Pollack, Rupal P Khurmi
    Abstract:

    The aim of this study was to perform exploratory analyses of the efficacy and safety of pancrelipase delayed-release capsules (Creon) in patients with Exocrine Pancreatic Insufficiency (EPI) with (n = 36) and without (n = 18) concurrent diabetes mellitus (DM).This was a retrospective, post hoc, subgroup (±DM) analysis of a double-blind, randomized, placebo-controlled trial of pancrelipase in patients with EPI due to chronic pancreatitis or pancreatectomy (total or partial). After a 5-day placebo run-in period (baseline), patients were randomized to pancrelipase (72,000 lipase units/meal, 36,000/snack) or placebo for 7 days. Outcomes included changes in coefficients of fat absorption (CFA) and nitrogen absorption (CNA) from baseline to the end of the double-blind period.Mean changes in nutrient absorption were greater with pancrelipase versus placebo in patients with DM (CFA, 36.0% vs 7.5%, P < 0.0001; CNA, 33.4% vs 3.7%, P = 0.0002) and without DM (CFA, 25.2% vs 12.3%, P = 0.0326; CNA, 39.1% vs 17.6%, P = 0.1187). Diabetes mellitus was not significantly associated with outcomes for CFA (P = 0.0802) and CNA (P = 0.2934). Incidences of adverse events, including hypoglycemia and hyperglycemia, were similar in the pancrelipase and placebo arms.Pancrelipase improved fat and protein absorption in patients with EPI due to chronic pancreatitis or pancreatectomy, with or without DM, and matched the safety profile previously reported.

  • efficacy and safety of pancrelipase pancreatin in patients with Exocrine Pancreatic Insufficiency and a medical history of diabetes mellitus
    Pancreas, 2016
    Co-Authors: David C. Whitcomb, Amit Bodhani, Katrin Beckmann, Suntje Sanderstruckmeier, Mahesh Fuldeore, Paul F Pollack, Shufang Liu, Rupal P Khurmi
    Abstract:

    OBJECTIVES The aim of this study was to perform exploratory analyses of the efficacy and safety of pancrelipase delayed-release capsules (Creon) in patients with Exocrine Pancreatic Insufficiency (EPI) with (n = 36) and without (n = 18) concurrent diabetes mellitus (DM). METHODS This was a retrospective, post hoc, subgroup (±DM) analysis of a double-blind, randomized, placebo-controlled trial of pancrelipase in patients with EPI due to chronic pancreatitis or pancreatectomy (total or partial). After a 5-day placebo run-in period (baseline), patients were randomized to pancrelipase (72,000 lipase units/meal, 36,000/snack) or placebo for 7 days. Outcomes included changes in coefficients of fat absorption (CFA) and nitrogen absorption (CNA) from baseline to the end of the double-blind period. RESULTS Mean changes in nutrient absorption were greater with pancrelipase versus placebo in patients with DM (CFA, 36.0% vs 7.5%, P < 0.0001; CNA, 33.4% vs 3.7%, P = 0.0002) and without DM (CFA, 25.2% vs 12.3%, P = 0.0326; CNA, 39.1% vs 17.6%, P = 0.1187). Diabetes mellitus was not significantly associated with outcomes for CFA (P = 0.0802) and CNA (P = 0.2934). Incidences of adverse events, including hypoglycemia and hyperglycemia, were similar in the pancrelipase and placebo arms. CONCLUSIONS Pancrelipase improved fat and protein absorption in patients with EPI due to chronic pancreatitis or pancreatectomy, with or without DM, and matched the safety profile previously reported.

  • a 6 month open label clinical trial of pancrelipase delayed release capsules creon in patients with Exocrine Pancreatic Insufficiency due to chronic pancreatitis or Pancreatic surgery
    Alimentary Pharmacology & Therapeutics, 2011
    Co-Authors: N B Gubergrits, Suntje Sanderstruckmeier, Steven Caras, Galina Vasileva, Ewa Maleckapanas, Yannan Shen, Glen A Lehman, David C. Whitcomb
    Abstract:

    Aliment Pharmacol Ther 2011; 33: 1152–1161 Summary 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 186 960 ± 74 640 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.

  • pancrelipase delayed release capsules creon for Exocrine Pancreatic Insufficiency due to chronic pancreatitis or Pancreatic surgery a double blind randomized trial
    The American Journal of Gastroenterology, 2010
    Co-Authors: David C. Whitcomb, Suntje Sanderstruckmeier, Galina Vasileva, Ewa Maleckapanas, N B Gubergrits, Yannan Shen, Glen A Lehman, Steven Caras
    Abstract:

    Pancrelipase Delayed-Release Capsules (CREON) for Exocrine Pancreatic Insufficiency due to Chronic Pancreatitis or Pancreatic Surgery: A Double-Blind Randomized Trial

David S Sanders - One of the best experts on this subject based on the ideXlab platform.

  • the role of fecal elastase 1 in detecting Exocrine Pancreatic disease
    Nature Reviews Gastroenterology & Hepatology, 2011
    Co-Authors: J S Leeds, Kofi Oppong, David S Sanders
    Abstract:

    Exocrine Pancreatic disease is thought to be uncommon in clinical practice and usually secondary to excess alcohol intake. Although excess alcohol intake does account for many cases of Exocrine Pancreatic disease, other conditions are associated with Exocrine Pancreatic Insufficiency and such dysfunction perhaps occurs more frequently than conventionally expected. A reliable, patient-friendly, cheap and easy to use test for Exocrine Pancreatic disease is yet to be established; however, in many countries the main (and often only available) method of assessment of Exocrine Pancreatic function is the fecal-elastase-1 test. This Review examines the role of fecal-elastase-1 testing in detecting Exocrine Pancreatic Insufficiency in a number of gastrointestinal and nongastrointestinal conditions and determines the value of Pancreatic enzyme supplementation in these settings.

  • Pancreatic Insufficiency in adult celiac disease do patients require long term enzyme supplementation
    Digestive Diseases and Sciences, 2010
    Co-Authors: K E Evans, J S Leeds, S Morley, David S Sanders
    Abstract:

    Celiac disease is associated with Exocrine Pancreatic Insufficiency. We previously reported that in 30% (20/66) of adult celiac patients with current or persistent diarrhea the underlying cause was Exocrine Pancreatic Insufficiency. Of these 20 patients, 19 initially improved on Pancreatic supplementation. To date, there are no published longitudinal studies. The 20 patients who had initially received therapy for Exocrine Pancreatic Insufficiency were prospectively followed-up for 4 years. Gastrointestinal symptoms, dietary adherence, celiac antibody status, and dose of enzyme supplementation were recorded. Fecal elastase-1 (Fel-1) was repeated to reassess Exocrine Pancreatic function. In the study, 19/20 patients were reviewed, as one had died (mean age 59.7 years, 7 males). The mean duration of celiac disease was 13.2 years. Eleven out of nineteen were still taking enzyme supplementation at a mean dose of 45,000 units of lipase per day. Only 1/11 reported no symptomatic benefit and 8/19 patients had discontinued supplementation because their diarrhea had improved. In the whole group there was a significant increase in Fel-1 levels over time, with median values of 90 μg/g at 0 months, 212 μg/g at 6 months, and 365 μg/g at follow-up (45–66 months)(p < 0.0001). Fecal elastase-1 is useful in identifying Exocrine Pancreatic Insufficiency in adult celiac patients with diarrhea. Our longitudinal data suggests that Pancreatic enzyme supplementation could be discontinued in a substantial proportion of patients as symptoms improve.

  • some patients with irritable bowel syndrome may have Exocrine Pancreatic Insufficiency
    Clinical Gastroenterology and Hepatology, 2010
    Co-Authors: J S Leeds, S Morley, Andrew D Hopper, Reena Sidhu, Alison Simmonette, Narges Azadbakht, Nigel Hoggard, David S Sanders
    Abstract:

    Background & Aims Patients with irritable bowel syndrome (IBS) might have other underlying pathologies. Pancreatic disease can be elusive—especially in the early stages, and some symptoms overlap with those of IBS. We evaluated the prevalence of Exocrine Pancreatic Insufficiency in diarrhea-predominant IBS (D-IBS) and assessed the effects of Pancreatic enzyme supplementation. Methods The study included patients who met the Rome II criteria for D-IBS, patients with chronic diarrhea, and subjects without diarrhea (controls). Subjects' baseline weight, stool frequency, stool consistency (using the Bristol score), and fecal elastase-1 (Fel-1) levels were determined. Patients were assessed using British Society of Gastroenterology IBS guidelines. Patients with Fel-1 levels less than 100 μg/g stool (indicating Pancreatic Exocrine Insufficiency; group 1) were compared with age- and sex-matched patients with D-IBS and normal levels of Fel-1 (group 2), given Pancreatic enzyme therapy, and reassessed at 12 weeks. Results Fel-1 levels were less than 100 μg/g in stool from 19 of 314 patients with D-IBS (6.1%; 95% confidence interval [CI], 3.7%–9.3%), none of the 105 patients with chronic diarrhea (95% CI, 0.0%–3.5%), and none of 95 controls (95% CI, 0.0–3.8%) ( P P P P = .003) were observed in patients in group 1, but not in group 2. Conclusions Pancreatic Exocrine Insufficiency was detected in 6.1% of patients who fulfilled the Rome II criteria for D-IBS. In these patients, Pancreatic enzyme therapy might reduce diarrhea and abdominal pain. Pancreatic Exocrine Insufficiency should be considered in patients with D-IBS.

  • is Exocrine Pancreatic Insufficiency in adult coeliac disease a cause of persisting symptoms
    Alimentary Pharmacology & Therapeutics, 2006
    Co-Authors: J S Leeds, S Morley, Andrew D Hopper, David P Hurlstone, S J Edwards, M E Mcalindon, A J Lobo, Mark Donnelly, David S Sanders
    Abstract:

    Summary Background Patients with coeliac disease may have diarrhoea despite being on a gluten-free diet. Aim To assess whether Exocrine Pancreatic Insufficiency causes persisting symptoms compared with controls, we determined whether Pancreatic enzyme supplementation provided symptomatic benefit in coeliac patients with chronic diarrhoea. Methods Patients (n = 259) were subdivided into four groups: (a) new coeliac disease (n = 57), (b) coeliac disease patients on a gluten-free diet without gastrointestinal symptoms (n = 86), (c) coeliac disease patients on a gluten-free diet with chronic diarrhoea (n = 66) and (d) patients with chronic diarrhoea without coeliac disease (n = 50). Stool frequency and weight, before and after treatment with Pancreatic enzyme supplementation were recorded. Results The prevalence of a low faecal elastase-1 within the groups was: group (A) six of 57 (11%), group (B) five of 86 (6%), group (C) 20 of 66 (30%) and group (D) two of 50 (4%). Low faecal elastase-1 was more frequent in coeliac disease patients with chronic diarrhoea vs. other subgroups of coeliac disease (P ≤ 0.0001) and controls (P ≤ 0.0003). In 18 of 20 stool frequency reduced following Pancreatic enzyme supplementation from four per day to one (P ≤ 0.001). No weight increase (P = 0.3) was observed. Conclusions Low faecal elastase is common in patients with coeliac disease and chronic diarrhoea, suggesting Exocrine Pancreatic Insufficiency. In this group of patients, Pancreatic enzyme supplementation may provide symptomatic benefit.

Suntje Sanderstruckmeier - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and safety of pancrelipase pancreatin in patients with Exocrine Pancreatic Insufficiency and a medical history of diabetes mellitus
    Pancreas, 2016
    Co-Authors: David C. Whitcomb, Amit Bodhani, Katrin Beckmann, Suntje Sanderstruckmeier, Mahesh Fuldeore, Paul F Pollack, Rupal P Khurmi
    Abstract:

    The aim of this study was to perform exploratory analyses of the efficacy and safety of pancrelipase delayed-release capsules (Creon) in patients with Exocrine Pancreatic Insufficiency (EPI) with (n = 36) and without (n = 18) concurrent diabetes mellitus (DM).This was a retrospective, post hoc, subgroup (±DM) analysis of a double-blind, randomized, placebo-controlled trial of pancrelipase in patients with EPI due to chronic pancreatitis or pancreatectomy (total or partial). After a 5-day placebo run-in period (baseline), patients were randomized to pancrelipase (72,000 lipase units/meal, 36,000/snack) or placebo for 7 days. Outcomes included changes in coefficients of fat absorption (CFA) and nitrogen absorption (CNA) from baseline to the end of the double-blind period.Mean changes in nutrient absorption were greater with pancrelipase versus placebo in patients with DM (CFA, 36.0% vs 7.5%, P < 0.0001; CNA, 33.4% vs 3.7%, P = 0.0002) and without DM (CFA, 25.2% vs 12.3%, P = 0.0326; CNA, 39.1% vs 17.6%, P = 0.1187). Diabetes mellitus was not significantly associated with outcomes for CFA (P = 0.0802) and CNA (P = 0.2934). Incidences of adverse events, including hypoglycemia and hyperglycemia, were similar in the pancrelipase and placebo arms.Pancrelipase improved fat and protein absorption in patients with EPI due to chronic pancreatitis or pancreatectomy, with or without DM, and matched the safety profile previously reported.

  • efficacy and safety of pancrelipase pancreatin in patients with Exocrine Pancreatic Insufficiency and a medical history of diabetes mellitus
    Pancreas, 2016
    Co-Authors: David C. Whitcomb, Amit Bodhani, Katrin Beckmann, Suntje Sanderstruckmeier, Mahesh Fuldeore, Paul F Pollack, Shufang Liu, Rupal P Khurmi
    Abstract:

    OBJECTIVES The aim of this study was to perform exploratory analyses of the efficacy and safety of pancrelipase delayed-release capsules (Creon) in patients with Exocrine Pancreatic Insufficiency (EPI) with (n = 36) and without (n = 18) concurrent diabetes mellitus (DM). METHODS This was a retrospective, post hoc, subgroup (±DM) analysis of a double-blind, randomized, placebo-controlled trial of pancrelipase in patients with EPI due to chronic pancreatitis or pancreatectomy (total or partial). After a 5-day placebo run-in period (baseline), patients were randomized to pancrelipase (72,000 lipase units/meal, 36,000/snack) or placebo for 7 days. Outcomes included changes in coefficients of fat absorption (CFA) and nitrogen absorption (CNA) from baseline to the end of the double-blind period. RESULTS Mean changes in nutrient absorption were greater with pancrelipase versus placebo in patients with DM (CFA, 36.0% vs 7.5%, P < 0.0001; CNA, 33.4% vs 3.7%, P = 0.0002) and without DM (CFA, 25.2% vs 12.3%, P = 0.0326; CNA, 39.1% vs 17.6%, P = 0.1187). Diabetes mellitus was not significantly associated with outcomes for CFA (P = 0.0802) and CNA (P = 0.2934). Incidences of adverse events, including hypoglycemia and hyperglycemia, were similar in the pancrelipase and placebo arms. CONCLUSIONS Pancrelipase improved fat and protein absorption in patients with EPI due to chronic pancreatitis or pancreatectomy, with or without DM, and matched the safety profile previously reported.

  • a 6 month open label clinical trial of pancrelipase delayed release capsules creon in patients with Exocrine Pancreatic Insufficiency due to chronic pancreatitis or Pancreatic surgery
    Alimentary Pharmacology & Therapeutics, 2011
    Co-Authors: N B Gubergrits, Suntje Sanderstruckmeier, Steven Caras, Galina Vasileva, Ewa Maleckapanas, Yannan Shen, Glen A Lehman, David C. Whitcomb
    Abstract:

    Aliment Pharmacol Ther 2011; 33: 1152–1161 Summary 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 186 960 ± 74 640 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.

  • pancrelipase delayed release capsules creon for Exocrine Pancreatic Insufficiency due to chronic pancreatitis or Pancreatic surgery a double blind randomized trial
    The American Journal of Gastroenterology, 2010
    Co-Authors: David C. Whitcomb, Suntje Sanderstruckmeier, Galina Vasileva, Ewa Maleckapanas, N B Gubergrits, Yannan Shen, Glen A Lehman, Steven Caras
    Abstract:

    Pancrelipase Delayed-Release Capsules (CREON) for Exocrine Pancreatic Insufficiency due to Chronic Pancreatitis or Pancreatic Surgery: A Double-Blind Randomized Trial

Xiangyu Zhang - One of the best experts on this subject based on the ideXlab platform.

  • screening and risk factors of Exocrine Pancreatic Insufficiency in critically ill adult patients receiving enteral nutrition
    Critical Care, 2013
    Co-Authors: Sheng Wang, Yugang Zhuang, Bojie Jiang, Xiangyu Zhang
    Abstract:

    Introduction Malnutrition is a frequent problem associated with detrimental clinical outcomes in critically ill patients. To avoid malnutrition, most studies focus on the prevention of inadequate nutrition delivery, whereas little attention is paid to the potential role of Exocrine Pancreatic Insufficiency (EPI). In this trial, we aim to evaluate the prevalence of EPI and identify its potential risk factors in critically ill adult patients without preexisting Pancreatic diseases.

  • screening and risk factors of Exocrine Pancreatic Insufficiency in critically ill adult patients receiving enteral nutrition
    Critical Care, 2013
    Co-Authors: Sheng Wang, Yugang Zhuang, Bojie Jiang, Xiangyu Zhang
    Abstract:

    Malnutrition is a frequent problem associated with detrimental clinical outcomes in critically ill patients. To avoid malnutrition, most studies focus on the prevention of inadequate nutrition delivery, whereas little attention is paid to the potential role of Exocrine Pancreatic Insufficiency (EPI). In this trial, we aim to evaluate the prevalence of EPI and identify its potential risk factors in critically ill adult patients without preexisting Pancreatic diseases. In this prospective cross-sectional study, we recruited 563 adult patients with critical illnesses. All details of the patients were documented, stool samples were collected three to five days following the initiation of enteral nutrition, and faecal elastase 1 (FE-1) concentrations were assayed using an enzyme-linked immunosorbent assay kit. Blood samples were also taken to determine serum amylase and lipase activity. The percentages of recruited patients with EPI (FE-1 concentration <200 μg/g) and severe EPI (FE-1 concentration <100 μg/g) were 52.2% and 18.3%, respectively. The incidences of steatorrhea were significantly different (P < 0.05) among the patients without EPI, with moderate EPI (FE-1 concentration = 100 to 200 μg/g) and severe EPI (FE-1 concentration < 100 μg/g). Both multivariate logistic regression analysis and z-tests indicated that the occurrence of EPI was closely associated with shock, sepsis, diabetes, cardiac arrest, hyperlactacidemia, invasive mechanical ventilation and haemodialysis. More than 50% of critically ill adult patients without primary Pancreatic diseases had EPI, and nearly one-fifth of them had severe EPI. The risk factors for EPI included shock, sepsis, diabetes, cardiac arrest, hyperlactacidemia, invasive mechanical ventilation and haemodialysis. NCT01753024