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PASS Information H9X-MC-B010 Non-interventional PASS Final Study Report Page 1 PASS Information Title Utilisation of dulaglutide in European countries: A cross-sectional, multi-country and multi-source drug utilisation study using electronic health record databases Version identifier of the final study report Version 1.0 Date of last version of the final study report N/A EU PAS register number EUPAS13783 Active substance Dulaglutide (ATC code: A10BJ05) Medicinal product(s): Trulicity 0.75 mg solution for injection Trulicity 1.5 mg solution for injection Product reference: EU/1/14/956 Procedure number: EMEA/H/C/002825 Marketing authorisation holder(s) Eli Lilly Nederland B.V. Joint PASS No Research question and objectives The purpose of this study is to describe how dulaglutide is used among different patient groups in Europe. Primary objective: To describe the frequency of dulaglutide use in the population and characterise by age, gender, main comorbidities, and main co- prescriptions overall and in the following subgroups of interest: o Populations of interest: • Patients with severe renal failure • Patients with hepatic disease • Patients with heart failure • Patients with severe gastrointestinal disease • Children and adolescents (<18 years of age) • Elderly patients (≥75 years of age) • Pregnant or breast-feeding women o Medication use: • Medication errors • Off-label use Secondary objective: To describe the off-label use among each of the above populations of interest. Country(-ies) of study France, Germany, Spain, Sweden and the United Kingdom Author PPD Signature of principal investigator Signature on file/see approval date below Approval Date: 14-Nov-2019 GMT H9X-MC-B010 Non-interventional PASS Final Study Report Page 2 Marketing Authorisation Holder Marketing authorisation holder (MAH) Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht The Netherlands MAH contact person PPD Eli Lilly and Company H9X-MC-B010 Non-interventional PASS Final Study Report Page 3 Table of Contents Section Page Table of Contents........................................................................................................................3 1. Abstract ..............................................................................................................................6 2. List of abbreviations..........................................................................................................10 3. Investigators......................................................................................................................12 4. Other responsible parties...................................................................................................13 5. Milestones.........................................................................................................................14 6. Rationale and background .................................................................................................15 7. Research question and objectives ......................................................................................16 8. Amendments and updates..................................................................................................17 9. Research methods .............................................................................................................18 9.1. Study design.................................................................................................................18 9.2. Setting..........................................................................................................................19 9.3. Subjects........................................................................................................................19 9.4. Variables......................................................................................................................19 9.4.1. Measurements of interest......................................................................................21 9.4.2. Collected variables...............................................................................................21 9.5. Data sources.................................................................................................................22 9.5.1. Disease analyser in France and Germany..............................................................22 9.5.2. SIDIAP in Spain ..................................................................................................23 9.5.3. NPR and SPDR in Sweden...................................................................................23 9.5.4. CPRD in the UK ..................................................................................................23 9.5.5. Summary of data sources .....................................................................................24 9.6. Bias..............................................................................................................................24 9.7. Study size.....................................................................................................................25 9.8. Data transformation......................................................................................................26 9.9. Statistical methods .......................................................................................................27 9.9.1. Main summary measures......................................................................................27 9.9.2. Main statistical methods.......................................................................................27 9.9.3. Missing values .....................................................................................................28 9.9.4. Amendments to the statistical analysis plan..........................................................28 9.10. Quality control .............................................................................................................28 10. Results ..............................................................................................................................29 10.1. Participants ..................................................................................................................29 H9X-MC-B010 Non-interventional PASS Final Study Report Page 4 10.1.1. France ..................................................................................................................29 10.1.2. Germany ..............................................................................................................30 10.1.3. Spain....................................................................................................................30 10.1.4. Sweden ................................................................................................................30 10.1.5. UK.......................................................................................................................30 10.2. Descriptive Data...........................................................................................................31 10.2.1. Overall.................................................................................................................31 10.2.1.1. Demographics and Populations of Interest ......................................................31 10.2.1.2. Comorbidities and Concomitant Medications..................................................33 10.2.2. By Populations of Interest ....................................................................................36 10.2.2.1. Demographics and Populations of Interest ......................................................36 10.2.2.1.1. France.......................................................................................................36 10.2.2.1.2. Germany...................................................................................................39 10.2.2.1.3. Spain ........................................................................................................42 10.2.2.1.4. Sweden.....................................................................................................44 10.2.2.1.5. UK............................................................................................................47 10.2.2.2. Comorbidities and Concomitant Medications..................................................49 10.2.2.2.1. France.......................................................................................................49 10.2.2.2.2. Germany...................................................................................................51 10.2.2.2.3. Spain ........................................................................................................54 10.2.2.2.4. Sweden.....................................................................................................56 10.2.2.2.5. UK............................................................................................................58 10.2.3. Clinical laboratory tests........................................................................................61 10.2.3.1. Overall ...........................................................................................................61 10.2.3.2. By populations of interest ...............................................................................64 10.2.3.2.1. France.......................................................................................................64 10.2.3.2.2. Germany...................................................................................................67
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