Cardiovascular, antidepressant and immunosuppressive drug use in relation to risk of cutaneous melanoma: a protocol for a prospective case-control study

BMJ Open. 2019 Feb 20;9(2):e025246. doi: 10.1136/bmjopen-2018-025246.

Abstract

Introduction: The incidence of cutaneous melanoma (hereafter melanoma) has increased dramatically among fair-skinned populations worldwide. In Norway, melanoma is the most rapidly growing type of cancer, with a 47% increase among women and 57% among men in 2000-2016. Intermittent ultraviolet exposure early in life and phenotypic characteristics like a fair complexion, freckles and nevi are established risk factors, yet the aetiology of melanoma is multifactorial. Certain prescription drugs may have carcinogenic side effects on the risk of melanoma. Some cardiovascular, antidepressant and immunosuppressive drugs can influence certain biological processes that modulate photosensitivity and immunoregulation. We aim to study whether these drugs are related to melanoma risk.

Methods and analysis: A population-based matched case-control study will be conducted using nation-wide registry data. Cases will consist of all first primary, histologically verified melanoma cases diagnosed between 2007 and 2015 identified in the Cancer Registry of Norway (14 000 cases). Ten melanoma-free controls per case (on date of case melanoma diagnosis) will be matched based on sex and year of birth from the National Registry of Norway. For the period 2004-2015, and by using the unique personal identification numbers assigned to all Norwegian citizens, the case-control data set will be linked to the Norwegian Prescription Database for information on drugs dispensed prior to the melanoma diagnosis, and to the Medical Birth Registry of Norway for data regarding the number of child births. Conditional logistic regression will be used to estimate associations between drug use and melanoma risk, taking potential confounding factors into account.

Ethics and dissemination: The project is approved by the Regional Committee for Medical Research Ethics in Norway and by the Norwegian Data Protection Authority. The study is funded by the Southeastern Norway Regional Health Authority. Results will be published in peer-reviewed journals and disseminated further through scientific conferences, news media and relevant patient interest groups.

Keywords: antidepressants; cardiovascular drugs; cutaneous melanoma; immunosuppressive; pharmacoepidemiology; prescription drugs.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antidepressive Agents / adverse effects*
  • Cardiovascular Agents / adverse effects*
  • Case-Control Studies
  • Female
  • Humans
  • Immunosuppressive Agents / adverse effects*
  • Incidence
  • Logistic Models
  • Male
  • Melanoma / epidemiology*
  • Melanoma / etiology
  • Middle Aged
  • Norway / epidemiology
  • Prospective Studies
  • Registries
  • Research Design
  • Risk Factors
  • Skin Neoplasms / epidemiology*
  • Skin Neoplasms / etiology
  • Young Adult

Substances

  • Antidepressive Agents
  • Cardiovascular Agents
  • Immunosuppressive Agents

Supplementary concepts

  • Melanoma, Cutaneous Malignant