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Drugs Real World Outcomes. 2018 Jun;5(2):109-116. doi: 10.1007/s40801-018-0133-1.

Use of Topical Tacrolimus and Topical Pimecrolimus in Four European Countries: A Multicentre Database Cohort Study.

Author information

1
PHARMO Institute for Drug Outcomes Research, Van Deventerlaan 30-40, 3528 AE, Utrecht, The Netherlands. josine.kuiper@pharmo.nl.
2
PHARMO Institute for Drug Outcomes Research, Van Deventerlaan 30-40, 3528 AE, Utrecht, The Netherlands.
3
University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
4
Epidemiology, RTI Health Solutions, Av. Diagonal, 605, 9-1, 08028, Barcelona, Spain.
5
Department of Public Health, University of Southern Denmark, J.B. Winsløws Vej 9B, 5000, Odense, Denmark.
6
Unit of Clinical Epidemiology, Department of Medicine, Centre for Pharmacoepidemiology, Karolinska Institutet, Solnavägen 1, 171 77, Stockholm, Sweden.
7
Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, UK.
8
Epidemiology, RTI Health Solutions, Research Triangle Park, 3040 Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.
9
Pharmacovigilance Department, Astellas Pharma Europe, Sylviusweg 62, 2333 BE, Leiden, The Netherlands.

Abstract

BACKGROUND:

Despite the concerns about a potential increased risk of skin cancer and lymphoma with the use of topical tacrolimus and pimecrolimus, no population-based studies have given an overview of the use of these drugs in Europe.

OBJECTIVE:

To assess the use of topical tacrolimus and pimecrolimus in children and adults in Europe.

METHODS:

Multicentre database cohort study comprising data from the Netherlands, Denmark, Sweden and the UK. We analysed users of topical tacrolimus and pimecrolimus starting from the date of first availability (between 2002 and 2003) or start establishment of the prescription database in Sweden (2006) through 2011. Use was assessed separately for children (≤ 18 years) and adults.

RESULTS:

32,052 children and 104,902 adults were treated with topical tacrolimus, and 32,125 children and 58,280 adults were treated with topical pimecrolimus. The number of users increased rapidly after first availability, especially for topical tacrolimus. Topical tacrolimus was more frequently used in all countries except Denmark. For both drugs, there was a decrease in users after 2004 in the Netherlands and Denmark and after 2005 in the UK, especially among children. This decrease was largest in Denmark. The decrease in the number of users was temporary for topical tacrolimus, while use remained relatively low for topical pimecrolimus.

CONCLUSIONS:

The number of topical tacrolimus and pimecrolimus users increased rapidly after regulatory approval. A transient reduction in topical tacrolimus use and a persistent reduction in topical pimecrolimus use was seen after 2004 in the Netherlands and Denmark and after 2005 in the UK.

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