(297) Flecainide and Risk of Skin Cancer: A Large Population-Based Case-Control Study in Spain and Denmark

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 628

Presenting Author(s)

Carlen Reyes
– Institut Universitari d�Investigaci� en Atenci� Prim�ria Jordi Gol, IDIAP Jordi Gol, BARCELONA, Barcelona, Spain

Co-Author(s)

Luz Maria M. León-Muñoz
– Government Delegation for the National Plan on Drugs, Ministry of Health, Madrid, Spain, Madrid, Madrid, Spain
Andrea Pistillo
– IDIAPJGol, Barcelona, Spain, Spain
Sigrún Alba Jóhannesdóttir Schmidt
– Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark, Denmark
Kasper Bruun Kristensen
– University of Southern Denmark, Denmark
Anton Pottegård, PhD, MSc
– University of Southern Denmark, Odense C, Denmark
Consuelo Huerta
– Assistant Professor Epidemiology and Public Health, Faculty of Medicine. Department of Public Health. Complutense University of Madrid, Spain
Talita Duarte-Salles
– IDIAPJGol, Barcelona, Spain, Barcelona, Catalonia, Spain
Diana Puente
– IDIAPJGol, Barcelona, Spain, Barcelona, Catalonia, Spain

An increased risk of melanoma has been reported previously in Denmark with the use of flecainide.

Objectives: To study the association between flecainide use and the risk of skin cancer in Spain and Denmark.

Methods: We conducted a multi-database case-control study in Spain (SIDIAP database from 2005 to 2017, BIFAP database from 2007 to 2017) and Denmark (Danish registries from 2001 to 2018). We included patients aged 18-85 years with at least 2 years of previous data and an incident diagnosis of melanoma or non-melanoma skin cancer (NMSC) cases and controls (matched 10:1 by age and sex). We excluded immunosuppressed subjects. We defined ever use as any prescription record and high use as a cumulative exposure of at least 200g (reference: never use). The cumulative dose was categorized for dose-response assessment. We used conditional logistic regression models to compute ORs (95% CI) adjusted for photosensitizing, anti-neoplastic, disease-specific drugs, and comorbidities.

Results: We identified a total of 7,809 melanoma cases in SIDIAP, 4,661 in BIFAP and 21,978 in Denmark; 64,230 NMSC cases in SIDIAP, 31,063 in BIFAP; and 152,821 in Denmark, and approximately 10 times as many controls. Compared with never use, and after adjusting for confounders, flecainide users (ever use) had an increased risk of skin cancer in Denmark (melanoma OR=1.58 (1.24-2.01) and, NMSC OR=1.39 (1.26-1.52). Flecainide users (ever) had an increased risk of NMSC in Spain (OR=1.24 (1.09-1.42) in BIFAP and, OR of 1.17 (1.06-1.28) in SIDIAP). The association with high -use of flecainide showed similar results in both countries. In Denmark, there was a non-significant dose-response pattern for melanoma and no apparent dose-response pattern for NMSC. In Spain, dose-response analyses confirmed the association with NMSC, but not melanoma.

Conclusions: Flecainide use was associated with an increased risk of melanoma and NMSC in Denmark, however, with inconsistent dose-response patterns. In Spain, flecainide use was associated with a higher risk of NMSC but not melanoma. Unmeasured confounding may have influenced our results.