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PASS Information Title Cilostazol Drug Utilisation Study PASS Information Title Cilostazol drug utilisation study Protocol version Version 2 identifier Date of last version of February 28, 2013 protocol EU PAS register number Registration is planned prior to study initiation once the protocol is final and has received regulatory endorsement by the Committee for Medicinal Products for Human Use (CHMP) Active substance Cilostazol, ATC code B01AC23, Platelet aggregation inhibitors excluding heparin Medicinal product Pletal, Ekistol Product reference UK/H/0291/001 and 002 Procedure number EMEA/H/A-31/1306 Marketing authorisation Otsuka Pharmaceutical Europe Ltd. holder(s) (MAH) Lacer S.A. Joint PASS No Research question and This study protocol was developed in the context of the European objectives Medicines Agency (EMA) referral (article 31 of Council Directive 2001/83/EC) on the risks and benefits of the use of cilostazol. The study objectives are to characterise patients using cilostazol according to demographics, comorbidity, comedications, and duration of treatment. In addition, the study will describe the dosing of cilostazol, the prescribing physician specialties, and the potential off-label prescribing. Country(-ies) of study Spain, United Kingdom, Germany, Sweden Author Jordi Castellsague, MD, MPH; Cristina Varas-Lorenzo, MD, MPH, PhD; Susana Perez-Gutthann, MD, MPH, PhD RTI Health Solutions Trav. Gracia 56 Atico 1 08006 Barcelona, Spain Telephone: +34.93.241.7766 Fax: +34.93.414.2610 E-mail: [email protected] CONFIDENTIAL 1 of 56 Marketing Authorisation Holder(s) Marketing authorisation Otsuka Pharmaceutical Europe Ltd holder(s) Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex, UB8 1LX, UK Lacer S.A. Sardenya 350 08025 Barcelona Spain MAH contact person Giuseppe Di Benedetto, MD PhD Senior Vice President, Medical Affairs and Compliance Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex, UB8 1LX, UK Telephone: +44 (0) 1895 207 113 Fax: +44 (0) 1895 207 100 E-mail: [email protected] CONFIDENTIAL 2 of 56 Cilostazol Drug Utilization Study 1 Table of Contents 1 Table of Contents ....................................................................................... 4 2 List of Abbreviations .................................................................................. 5 3 Responsible Parties ................................................................................... 6 4 Abstract ..................................................................................................... 7 5 Amendments and Updates ....................................................................... 10 6 Milestones and Timeline .......................................................................... 11 7 Rationale and Background ....................................................................... 11 8 Research Question and Objectives ........................................................... 12 9 Research Methods ................................................................................... 13 9.1 Study Design ..................................................................................... 13 9.2 Setting ............................................................................................. 14 9.2.1 Source Population ................................................................. 14 9.2.2 Study Period ........................................................................ 14 9.2.3 Study Cohort ....................................................................... 15 9.2.4 Inclusion Criteria .................................................................. 15 9.2.5 Exclusion Criteria ................................................................. 15 9.2.6 Follow-up ............................................................................ 16 9.3 Variables ........................................................................................... 16 9.3.1 Use of Cilostazol and Patterns of Use ....................................... 16 9.3.2 Characterisation of New Users—Overview ................................ 16 9.3.3 Characterisation of New Users at the Start Date ........................ 17 9.3.4 Concurrent Use of Medications That May Interact With Cilostazol . 21 9.3.5 Concurrent Use of Selected Antithrombotic Agents .................... 23 9.3.6 Baseline Characterisation of New Users for the Assessment of Planned Risk Minimisation Measures (SmPC Changes) ................ 24 9.3.7 Indications Associated With Treatment and Off-Label Prescribing . 27 9.3.8 Assessment of Hospitalisations During Treatment With Cilostazol 27 9.3.9 Speciality of Prescribers ........................................................ 27 9.4 Data Sources ..................................................................................... 28 9.4.1 Status of Contacts With the Study Databases ........................... 28 9.4.2 Description of Databases ....................................................... 28 9.5 Study Size ........................................................................................ 35 9.6 Data Collection and Management .......................................................... 36 9.7 Data Analysis .................................................................................... 36 9.7.1 Number of Users and Patterns of Use ...................................... 36 9.7.2 Characterisation of Users at the Start Date .............................. 37 9.7.3 Use of Medications Potentially Interacting With Cilostazol ........... 37 9.7.4 Concurrent Use of Antithrombotic Agents ................................. 38 9.7.5 Assessment of Changes to the Summary of Product Characteristics ......................................................................................... 38 9.7.6 Assessment of Contraindications ............................................. 38 9.7.7 Indications and Off-Label Use ................................................. 39 9.7.8 Assessment of hospitalisations during treatment with cilostazol ... 39 9.7.9 Speciality of Prescribers at the Start Date ................................ 39 9.8 Quality Control .................................................................................. 39 CONFIDENTIAL 4 of 56 Cilostazol Drug Utilization Study 9.9 Limitations of the Research Methods ..................................................... 40 10 Protection of Human Subjects ................................................................. 40 10.1 Other Good Research Practice .............................................................. 42 11 Management and Reporting of Adverse Events/Adverse Reactions ......... 42 12 Plans for Disseminating and Communicating Study Results ..................... 42 13 References ............................................................................................... 43 Annex 1. List of Stand-Alone Documents ......................................................... 46 Annex 2. ENCePP Checklist for Study Protocols ............................................... 47 Annex 3. List of Medications Interacting With Cytochrome P450 .................... 54 List of Tables Table 1. Estimated Study Period in Each Study Database .................................... 15 Table 2. Types of Diagnosis, Procedure, and Medication Codes in the Study Databases ....................................................................................... 17 Table 3. Diagnostic Codes for Comorbid Conditions ............................................ 18 Table 4. Anatomical Therapeutic Chemical Codes for Comedications ..................... 20 Table 5. Medications Potentially Interacting With Cilostazol ................................. 22 Table 6. Proposed Changes in the Labelling of Cilostazol and Characterisation of Users .............................................................................................. 24 Table 7. Status in Each Database .................................................................... 28 Table 8. Main Features of Selected European Databases ..................................... 32 Table 9. Preliminary Number of Users of Cilostazol in the Study Databases ........... 35 Table 10. Binomial Confidence Intervals for Different Study Sizes and Prevalence of Disease and Conditions Including Off-Label Use .................................... 36 List of Figures Figure 1. Overview of Study Design .................................................................. 14 2 List of Abbreviations ALT alanine aminotransferase AST aspartate aminotransferase ATC Anatomical Therapeutic Chemical (classification system) BUN blood urea nitrogen CMBD-AH Catalan Health Services database of hospital admissions CYP cytochrome P-450 DDD defined daily dose DUS drug utilisation study EBM codes used for treatments and diagnostic procedures (Einheitlicher Bewertungsmaßstab), GePaRD EBS ambulatory operation or procedure codes, GePaRD EMA European Medicines Agency CONFIDENTIAL 5 of 56 Cilostazol Drug Utilization Study HCP health care provider GePaRD German Pharmacoepidemiological Research Database GGT gamma-glutamyl transpeptidase GP general practitioner GVP Guideline on Good Pharmacovigilance Practice IACS Aragón Institute of Health Sciences (Instituto Aragonés de Ciencias de la Salud) ICD-10 International Statistical Classification of Diseases and Related Health Problems, 10th Revision ICD-10-CM International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Clinical Modification ICD-10-GM International Statistical Classification
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