A 2-year post-authorisation safety study of high-strength pancreatic enzyme replacement therapy (pancreatin 40000) in cystic fibrosis.

At the request of the Medicines and Healthcare Regulatory Agency and in agreement with the appropriate authorities, an observational, multi-centre, non-interventional, post-authorisation safety study of high-strength pancreatic enzymes was conducted. Patients with exocrine pancreatic insufficiency due to cystic fibrosis (CF) who had previously taken high doses of pancreatic enzymes received pancreatin 40000 capsules 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. 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. Sixty four patients were enrolled at nine UK centres. Two deaths occurred during the study, which were considered unrelated to therapy by investigators. There was no further serious suspected adverse drug reactions related to pancreatin 40000 and no cases of fibrosing colonopathy. Daily lipase doses were reduced by 11% after switching to pancreatin 40000. Maldigestion symptoms improved and mean body weight increased from baseline to last observation. 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 40000.

Authors: Littlewood, James M.; Connett Gary J.; Sander-Struckmeier, Suntje; Henniges, Friederike. ;Full Source: Expert Opinion on Drug Safety 2011, 10(2), 197-203 (UK) ;