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A 2-year post-authorization safety study of high-strength pancreatic enzyme replacement therapy (pancreatin 40,000) in cystic fibrosis

A 2-year post-authorization safety study of high-strength pancreatic enzyme replacement therapy (pancreatin 40,000) in cystic fibrosis
A 2-year post-authorization safety study of high-strength pancreatic enzyme replacement therapy (pancreatin 40,000) in cystic fibrosis

Objective: At the request of the Medicines and Healthcare Regulatory Agency and in agreement with the appropriate authorities, an observational, multi-center, non-interventional, post-authorization safety study of high-strength pancreatic enzymes was conducted. Research design and methods: Patients with exocrine pancreatic insufficiency due to cystic fibrosis (CF) who had previously taken high doses of pancreatic enzymes received pancreatin 40,000 capsules (Creon 40,000 Minimicrospheres, Abbott GmbH, Hanover, Germany) as part of their normal treatment for up to 2 years. Initial doses were calculated to match previous established doses in lipase units, with adjustment if required. Main outcome measures: Safety focused on serious suspected adverse drug reactions. Maldigestion symptoms and body weight were also monitored. Patients were managed according to general guidelines common to all major CF units in the UK, although minor variations were expected. The coefficient of fat absorption was not assessed as this was a safety rather than an efficacy study. Results: Sixty-four patients were enrolled at nine UK centers. Two deaths occurred during the study, which were considered unrelated to therapy by investigators. There were no further serious suspected adverse drug reactions related to pancreatin 40,000 and no cases of fibrosing colonopathy. Daily lipase doses were reduced by 11% after switching to pancreatin 40,000. Maldigestion symptoms improved and mean body weight increased from baseline to last observation (mean ++ 6.1 kg in patients < 18 years old). Conclusions: No safety concerns were identified with pancreatin 40,000 therapy for up to 2 years. Daily lipase doses were not increased when switching to pancreatin 40,000.

cystic fibrosis, exocrine pancreatic insufficiency, high-dose, pancreatic enzymes, pancreatin, safety
1474-0338
197-203
Littlewood, James M.
c3424885-a25b-4f63-b33a-5d201f146284
Connett, Gary J.
55d5676c-90d8-46bf-a508-62eded276516
Sander-Struckmeier, Suntje
151f1be5-2a85-4f16-bc6f-c46cf107f688
Henniges, Friederike
c7427470-3c96-4fb0-b52e-952ee0e04c5c
Littlewood, James M.
c3424885-a25b-4f63-b33a-5d201f146284
Connett, Gary J.
55d5676c-90d8-46bf-a508-62eded276516
Sander-Struckmeier, Suntje
151f1be5-2a85-4f16-bc6f-c46cf107f688
Henniges, Friederike
c7427470-3c96-4fb0-b52e-952ee0e04c5c

Littlewood, James M., Connett, Gary J., Sander-Struckmeier, Suntje and Henniges, Friederike (2011) A 2-year post-authorization safety study of high-strength pancreatic enzyme replacement therapy (pancreatin 40,000) in cystic fibrosis. Expert Opinion on Drug Safety, 10 (2), 197-203. (doi:10.1517/14740338.2011.552499).

Record type: Article

Abstract

Objective: At the request of the Medicines and Healthcare Regulatory Agency and in agreement with the appropriate authorities, an observational, multi-center, non-interventional, post-authorization safety study of high-strength pancreatic enzymes was conducted. Research design and methods: Patients with exocrine pancreatic insufficiency due to cystic fibrosis (CF) who had previously taken high doses of pancreatic enzymes received pancreatin 40,000 capsules (Creon 40,000 Minimicrospheres, Abbott GmbH, Hanover, Germany) as part of their normal treatment for up to 2 years. Initial doses were calculated to match previous established doses in lipase units, with adjustment if required. Main outcome measures: Safety focused on serious suspected adverse drug reactions. Maldigestion symptoms and body weight were also monitored. Patients were managed according to general guidelines common to all major CF units in the UK, although minor variations were expected. The coefficient of fat absorption was not assessed as this was a safety rather than an efficacy study. Results: Sixty-four patients were enrolled at nine UK centers. Two deaths occurred during the study, which were considered unrelated to therapy by investigators. There were no further serious suspected adverse drug reactions related to pancreatin 40,000 and no cases of fibrosing colonopathy. Daily lipase doses were reduced by 11% after switching to pancreatin 40,000. Maldigestion symptoms improved and mean body weight increased from baseline to last observation (mean ++ 6.1 kg in patients < 18 years old). Conclusions: No safety concerns were identified with pancreatin 40,000 therapy for up to 2 years. Daily lipase doses were not increased when switching to pancreatin 40,000.

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More information

e-pub ahead of print date: 23 February 2011
Published date: March 2011
Keywords: cystic fibrosis, exocrine pancreatic insufficiency, high-dose, pancreatic enzymes, pancreatin, safety

Identifiers

Local EPrints ID: 419578
URI: http://eprints.soton.ac.uk/id/eprint/419578
ISSN: 1474-0338
PURE UUID: c0bc8efb-5d01-4fa3-a806-cf6830293496
ORCID for Gary J. Connett: ORCID iD orcid.org/0000-0003-1310-3239

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Date deposited: 13 Apr 2018 16:30
Last modified: 29 Oct 2019 01:23

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Contributors

Author: James M. Littlewood
Author: Gary J. Connett ORCID iD
Author: Suntje Sander-Struckmeier
Author: Friederike Henniges

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