Pharmacoepidemiology of pancreatin use in non-cystic fibrosis patients and comparison of all-cause mortality with that of their matched controls

Date of ISAC Approval: 
29/06/2016
Lay Summary: 
In addition to sugar metabolism, the pancreas is also vital to digestion. Certain diseases such as pancreatitis, cystic fibrosis, pancreatic cancer, and diabetes stop the pancreas producing digestive enzymes that help break down food requiring pancreatic enzyme replacement therapy (pancreatin). Despite its importance the role of pancreatic therapy on longer-term health outcomes is has not been well studied. This study will examine the characteristics of patients who receive pancreatin within disease subgroups compared to those who do not. The main aim of the study is to determine whether pancreatin therapy has any influence on overall survival among patients within relevant disease subgroups. The findings of the study will help health professionals prioritise pancreatin therapy in patients who may require it.
Technical Summary: 
The proposed research will study the pharmacoepidemiology and long-term outcomes associated with Creon pancreatin use in subgroups of patients with pancreatic exocrine insufficiency (PEI) due to aetiologies other than cystic fibrosis and diabetes. Within these subgroups we aim to compare the outcomes of Creon pancreatin-treated cases with non-pancreatin-treated matched controls. The first part of the proposed research will be descriptive in nature. We aim to describe the therapeutic indications associated with Creon pancreatin therapy; preceding and concomitant treatments; clinical events &/or tests, and treatment pathways which are related/associated to/with Creon pancreatin prescription. The annual prevalence and incidence of PEI within the study observation period will be determined. Following this we aim to compare the risk of all-cause mortality (ACM) following first-line Creon pancreatin monotherapy with that of matched non-pancreatin-treated PEI or matched diabetic controls respectively. Baseline characteristics will be evaluated to help determine the generalisability of the study population to other populations. Non-parametric univariate analysis of time to ACM will be performed using the Kaplan-Meier (KM) method. Dependent on the data, time to ACM will be modelled using either semi-parametric or parametric multivariate survival models.
Health Outcomes to be Measured: 
The risk of all-cause mortality (ACM) following first-line Creon pancreatin monotherapy with that of matched non-pancreatin-treated PEI or matched diabetic controls respectively
Collaborators: 

Dr Chris Poole - Chief Investigator - Boehringer-Ingelheim - UK
Andres Diaz Ramirez - Researcher - Mylan Inc
Bridgitte Kalsch - Researcher - Mylan Inc
Dr Christian Bannister - Researcher - Digital Health Labs Limited
Hans-Friedrich Koch - Researcher - Mylan Inc
Harald Schrem - Researcher - Hannover Medical School
Johannes-Matthias Lohr - Researcher - Karolinska Institute Sweden
Keith J Roberts - Researcher - University Hospital Bristol
Michael Kirby - Researcher - The Prostate Centre
Nils Ewald - Researcher - Justus-Liebig University Giessen

Linkages: 
HES Admitted;ONS;Patient IMD;Practice IMD (Standard)