Understanding Cilostazol Use Before 2013 Labeling Changes

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Cilostazol is a blood clotting inhibitor drug approved in Europe in 2002. It is used to alleviate painful leg cramps during exercise caused by a lack of blood flow. In 2013, the European Medicines Agency recommended labeling changes and requested a drug utilization study to evaluate the impact of these changes. 

To support this evaluation, researchers from RTI Health Solutions, Aragon Public Health Institute, IDIAP Jordi Gol, Karolinska Institutet and the Bremen Institute for Social and Preventive Medicine conducted a utilization study to determine the characteristics of cilostazol users prior to 2013. 

The study, published in Pharmacoepidemiology and Drug Safety, reports that most users are elderly, and have heart disease and other chronic illnesses. These findings indicate that this is a vulnerable population at high risk of complications, especially cardiovascular events. 

The goal of this study was to provide a baseline assessment of the characteristics of cilostazol users before labeling changes were implemented in 2013. A second drug utilization study to determine characteristics after the labeling changes will soon be complete. This will allow the comparison of characteristics before and after the recommended labeling changes and help determine the impact of the changes. 

Characterization of new users of cilostazol in the UK, Spain, Sweden, and Germany. Castellsague J, Perez-Gutthann S, Calingaert B, Bui C, Varas-Lorenzo C, Arana A, Prados-Torres A, Poblador-Plou B, Gonzalez-Rubio F, Giner-Soriano M, Roso-Llorach A, Linders M, Citarella A, Scholle O, Blenk T, Garber E. DOI: 10.18553/jmcp.2017.23.2.125.

Read more about our epidemiological research involving drug utilization studies. 

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