4.7 Article

Flecainide and risk of skin neoplasms: Results of a large nested case-control study in Spain and Denmark

期刊

FRONTIERS IN PHARMACOLOGY
卷 13, 期 -, 页码 -

出版社

FRONTIERS MEDIA SA
DOI: 10.3389/fphar.2022.1002451

关键词

case-control studies; flecainide; skin neoplasm; database; melanoma

资金

  1. AEMPS
  2. Instituto de Salud Carlos III (ISCIII) [CP21/00023]
  3. European Union

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This study aimed to investigate the association between the use of flecainide and the risk of melanoma and non-melanoma skin cancer in Spain and Denmark. The results showed that the use of flecainide was associated with an increased risk of melanoma and non-melanoma skin cancer.
Background:A previous study in Denmark suggested an increased melanoma risk associated with the use of flecainide. Objective:To study the association between flecainide use and the risk of melanoma and non-melanoma skin cancer in Spain and Denmark. Methods:We conducted a multi-database case-control study in (database/study period) Spain (SIDIAP/2005-2017 and BIFAP/2007-2017) and Denmark (Danish registries/2001-2018). We included incident cases of melanoma or non-melanoma skin cancer (NMSC) aged >= 18 with >= 2 years of previous data (>= 10 years for Denmark) before the skin cancer and matched them to controls (10:1 by age and sex). We excluded persons with immunosuppression or previous cancer. We defined ever-use as any prescription fill and high-use as a cumulative dose of at least 200 g (reference: never-use). We categorized a cumulative dose for a dose-response assessment. We used conditional logistic regression to compute ORs (95% CI) adjusted for photosensitizing, anti-neoplastic, disease-specific drugs and comorbidities. Results:The total numbers of melanoma/NMSC cases included were 7,809/64,230 in SIDIAP, 4,661/31,063 in BIFAP, and 27,978/152,821 in Denmark. In Denmark, high-use of flecainide was associated with increased adjusted ORs of skin cancer compared with never-use [melanoma: OR 1.97 (1.38-2.81); NMSC: OR 1.34 (1.15-1.56)]. In Spain, an association between high-use of flecainide and NMSC was also observed [BIFAP: OR 1.42 (1.04-1.93); SIDIAP: OR 1.19 (0.95-1.48)]. There was a non-significant dose-response pattern for melanoma in Denmark and no apparent dose-response pattern for NMSC in any of the three databases. We found similar results for ever-use of flecainide. Conclusion:Flecainide use was associated with an increased risk of melanoma (Denmark only) and NMSC (Denmark and Spain) but without substantial evidence of dose-response patterns. Further studies are needed to assess for possible unmeasured confounders.

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