November 12, 2014
Fishman, Elliot K
P30 CA006973/CA/NCI NIH HHS/
AJR Am J Roentgenol. 2013 Jul;201(1):W29-39. doi: 10.2214/AJR.12.9956.
Author Address: Department of Radiology, Johns Hopkins University School of Medicine, JHOC 3251, 601 N Caroline St, Baltimore, MD 21287, USA. email@example.com
Reference Type: Journal Article
Record Number: 5341Author: Ramesh, H., Reddy, N., Bhatia, S., Rajkumar, J. S., Bapaye, A., Kini, D., Kalla, M. and Thorat, V.
Title: A 51-week, open-label clinical trial in India to assess the efficacy and safety of pancreatin 40000 enteric-coated minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis
Short Title: A 51-week, open-label clinical trial in India to assess the efficacy and safety of pancreatin 40000 enteric-coated minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis
Alternate Journal: Pancreatology : official journal of the International Association of Pancreatology
ISSN: 1424-3911 (Electronic)
Accession Number: 23561971
Drug Delivery Systems
Pancreatin/administration & dosage/*adverse effects/*therapeutic use
Pancreatitis, Chronic/*drug therapy
Abstract: BACKGROUND/OBJECTIVES: To assess the efficacy and safety of pancreatin (pancrelipase) enteric-coated minimicrospheres (MMS) over a one-year period in patients with pancreatic exocrine insufficiency (PEI) due to chronic pancreatitis (CP). METHODS: This was a 51-week, open-label extension (OLE) of a one-week, multicenter, double-blind, randomized, placebo-controlled trial in India that enrolled patients >/=18 years of age with confirmed PEI due to CP. Patients received pancreatin (Creon((R)) 40000 MMS) at a dose of 80,000 Ph. Eur. lipase units with each of three main meals/day and 40,000 with each of up to three snacks/day. RESULTS: Of 61 patients entering the OLE, 48 completed treatment (nine were lost to follow up, two withdrew consent, one discontinued due to adverse event [acute exacerbation of CP], one protocol violation). There were significant improvements from baseline to end of OLE in mean +/- SD coefficient of fat absorption (CFA: 22.7 +/- 12.2%), coefficient of nitrogen absorption (CNA: 6.5 +/- 7.9%), body weight (4.9 +/- 4.9 kg), BMI (1.9 +/- 1.9 kg/m(2)), and most nutritional laboratory parameters tested (p </= 0.001). Mean daily stool frequency was reduced from 2.8 to 1.6 (p < 0.001). Improvements in clinical symptoms, clinical global impression of disease symptoms, and quality of life were also observed. Treatment-emergent adverse events (TEAEs) were observed in 64% of patients overall. Only 13% of patients experienced TEAEs judged treatment related. CONCLUSIONS: In patients with PEI due to CP, treatment with pancreatin for one year was associated with significant improvements in fat absorption, nitrogen absorption, and nutritional parameters, improvements in clinical symptoms, and a favorable safety and tolerability profile.