- Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. [Randomized Controlled Trial]J Cyst Fibros 2016; 15(5):675-80JC
- CONCLUSIONS: Zenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI. NCT01641393.
- Pancreatic enzymes prepared in bicarbonate solution for administration through enteral feeding tubes. [Journal Article]Am J Health Syst Pharm 2015; 72(14):1210-4AJ
- CONCLUSIONS: The dissolution of enteric coated granules in sodium bicarbonate varied with the pancrelipase product and dose. Zenpep 40,000 lipase units was found to most efficiently dissolve in sodium bicarbonate, possibly due to the consistent size of the product's granules and visibly thinner and uniform enteric coating.
- Dependence of PERT endpoint on endogenous lipase activity. [Review]Pancreas 2014; 43(8):1232-8P
- CONCLUSIONS: The CFA% defines lipase activity as a percentage of converting substrate of "Total Daily Dietary Fat Intake." PERT trials performed to date have modified the definition to converting the "Shared Daily Fat Intake," generating "Partial CFA" for the exogenous lipase: the higher the activity of coexisting endogenous lipase, the lower the "Partial CFA" of exogenous measured. This review shows that "Partial CFA" is not CFA. Enrollment of patients with low HPLA during treatment may improve the interpretability of "Partial CFA" measured by PERT trials.
- Long-term experience with ZENPEP in infants with exocrine pancreatic insufficiency associated with cystic fibrosis. [Journal Article]J Pediatr Gastroenterol Nutr 2014; 59(5):612-5JP
- The objective of our study was to determine whether infants with cystic fibrosis who developed exocrine pancreatic insufficiency in early infancy would tolerate long-term treatment with ZENPEP (pancrelipase) delayed-release capsules, containing 3000 US Pharmacopeia units of lipase/capsule, and demonstrate consistent long-term growth. The most common treatment-emergent adverse events were diarrhea…
The objective of our study was to determine whether infants with cystic fibrosis who developed exocrine pancreatic insufficiency in early infancy would tolerate long-term treatment with ZENPEP (pancrelipase) delayed-release capsules, containing 3000 US Pharmacopeia units of lipase/capsule, and demonstrate consistent long-term growth. The most common treatment-emergent adverse events were diarrhea, vomiting, and constipation (mild or moderate). At study completion, median weight-for-age percentiles increased from 22nd to 49th, median length-for-age percentiles increased from 36.5th to 42nd, and median weight-for-length percentiles increased from 41.5th to 55.5th. Long-term treatment (up to 12 months) of infants with exocrine pancreatic insufficiency owing to cystic fibrosis with ZENPEP was well tolerated and associated with improved growth parameters. This is the first long-term study of pancreatic enzyme replacement therapy conducted in this patient population.
- Pancreatic enzyme supplementation. [Review]Curr Opin Pediatr 2011; 23(5):541-4CO
- CONCLUSIONS: These new preparations, Creon, Zenpep, and Pancreaze, demonstrated improvement in the absorption of fat and nitrogen in patients with pancreatic insufficiency related to cystic fibrosis. Some patient variability to response continues, so clinicians need to continue to titrate dose and preparations based on weight gain and patient response.
- Pancreatic enzyme products: digesting the changes. [Review]Ann Pharmacother 2011; 45(5):658-66AP
- CONCLUSIONS: At this time, Creon is an appropriate first-line agent, as it has been approved for chronic pancreatitis, pancreatectomy, and cystic fibrosis.
- Efficacy of a novel pancreatic enzyme product, EUR-1008 (Zenpep), in patients with exocrine pancreatic insufficiency due to chronic pancreatitis. [Randomized Controlled Trial]Pancreas 2011; 40(3):376-82P
- CONCLUSIONS: Our findings suggest that CP patients with EPI benefit from a low dose of ZENPEP, whereas the high dose might be needed for patients with more severe EPI.
- Pancrelipase for pancreatic disorders: An update. [Review]Drugs Today (Barc) 2010; 46(11):855-66DT
- Pancrelipase is a porcine pancreatic extract which contains the digestive enzymes lipases, proteases and amylases. In patients with pancreatic exocrine insufficiency (PEI) from conditions such as chronic pancreatitis, pancreatectomy and cystic fibrosis, pancrelipase can be used as pancreatic enzyme replacement therapy (PERT). Pancrelipase can reverse steatorrhea, prevent weight loss, control pain…
Pancrelipase is a porcine pancreatic extract which contains the digestive enzymes lipases, proteases and amylases. In patients with pancreatic exocrine insufficiency (PEI) from conditions such as chronic pancreatitis, pancreatectomy and cystic fibrosis, pancrelipase can be used as pancreatic enzyme replacement therapy (PERT). Pancrelipase can reverse steatorrhea, prevent weight loss, control pain and correct other nutritional deficiencies resulting from exocrine insufficiency. Various forms of pancreatic enzymes were being marketed as over-the-counter medications prior to the recent FDA declaration that all pancreatic enzyme products had to obtain approval as new drugs before marketing. On the basis of evidence from recent randomized controlled trials, three pancrelipase formulations (Creon®, Zenpep® and Pancreaze®) have been approved by the FDA as effective treatments for PEI. Although several tests exist for the detection of PEI, early diagnosis still remains a challenge. Individualization of the timing of treatment initiation and dosage requirements is needed to achieve optimal effectiveness. When used at recommended doses, pancrelipase is a safe medication. Appropriate use of pancrelipase in patients with pancreatic exocrine insufficiency can achieve symptomatic relief, prevent morbidity/mortality and also improve quality of life.
- EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. [Randomized Controlled Trial]J Cyst Fibros 2009; 8(6):405-17JC
- CONCLUSIONS: EUR-1008 was safe, well tolerated, and effective in CF patients of all ages with EPI-associated malabsorption in two clinical trials. Treatment led to clinically and statistically significant improvements in CFA and CNA in the randomized study, and control of malabsorption and clinical symptoms in both studies.