Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

CILOSTAZOL

Medical condition to be studied

Intermittent claudication
Population studied

Short description of the study population

All individuals registered in the study databases since the date of the first recorded prescription of cilostazol in each database
 The Aragón Health Sciences Institute (Instituto Aragonés de Ciencias de la Salud [IACS]) database, Spain
 The Information System for the Advancement of Research in Primary Care (Sistema d’Informació per el Desenvolupament de la Investigació en Atenció Primària [SIDIAP]) database in Catalonia, Spain
 The German Pharmacoepidemiological Research Database (GePaRD ), Germany
 The Health Improvement Network (THIN), United Kingdom (UK)
 The Swedish National Databases.

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

5600
Study design details

Main study objective

To describe: -the characteristics of new users of cilostazol according to 1)demographics, 2)baseline comorbidity including conditions listed in the SmPC and the RMP as potential or identified safety concerns, 3)baseline and concurrent use of medications potentially interacting with cilostazol, and 4)specific comorbidity-the duration of the use of cilostazol and discontinuation patterns

Outcomes

patient characterization and prescription patterns

Data analysis plan

The use and patterns of use of cilostazol will be summarized by the total number of users, prescriptions, and number of defined daily doses (DDDs), and by the number of users according to daily dose and duration of use. Characteristics of users, comorbidity, comedications, use of interacting drugs, and conditions defined for the evaluation of risk minimization measures, contraindications, indications, off-label use and prescriber speciality will be described as number and percentage of patients with each condition. All analysis will be stratified by age and sex.
Documents
Study results

Cilostazol DUS2_Final_Report_01Feb2017

English (3.31 MB - PDF)View document
Study publications
Castellsague J, Calingaert B, Poblador-Plou B, Giner-Soriano M, Linder M, Schol…
Castellsague J, Perez-Gutthann S, Calingaert B, Bui C, Varas-Lorenzo C, Arana A…
Jordi Castellsague J, Poblador-Plou B, Giner-Soriano M, Linder M, Scholle O, Ca…