Real‐world insights into risk of developing cardiovascular disease following GnRH agonists versus antagonists for prostate cancer: a methodological protocol to a study using five European databases

TY - JOUR

T1 - Real‐world insights into risk of developing cardiovascular disease following GnRH agonists versus antagonists for prostate cancer

T2 - a methodological protocol to a study using five European databases

AU - George, Gincy

AU - Scailteux, Lucie-Marie

AU - Garmo, Hans

AU - Balusson, Frédéric

AU - Cardwell, Christopher

AU - De Coster, Greet

AU - De Schutter , Harlinde

AU - Kuiper, Josephina G.

AU - McMenamin, Úna

AU - Verbeeck, Julie

AU - Van Hemelrijck, Mieke

PY - 2019/8/1

Y1 - 2019/8/1

N2 - One of the more recently investigated adverse long‐term side effects of gonadotropin‐releasing hormone (GnRH) agonists for prostate cancer (PCa) is cardiovascular disease (CVD). Studies suggest lower risk of CVD following GnRH antagonists (degarelix) than GnRH agonists. This protocol describes precise codes used to extract variables from five European databases for a study that compares risk of CVD following GnRH agonists and antagonists for PCa.PCa men on primary GnRH agonists or antagonists were identified from the UK THIN (The Health Improvement Network) database, National Health Service (NHS) Scotland, Belgian Cancer Registry (BCR), Dutch PHARMO Database Network and French National Database (SNIIRAM). Cohort entry was defined as date of treatment initiation. CVD event was defined as any first incident or fatal CVD after cohort entry. Readcodes in THIN and ICD codes in NHS Scotland, BCR, PHARMO and SNIIRAM were used to extract variables. Risk of Bias in Non‐randomised studies of Interventions (ROBINS‐I) tool was used to assess the potential risk of biases in this study. 51 572 men with a median follow‐up time of 2 years started on GnRH agonists and 2 417 men with a median follow‐up time of 1 year started on GnRH antagonists between 2010 and 2017 in the UK, Scotland, Belgium, the Netherlands and France. Data from five countries improved the study power and internal validity required to compare risk of CVD between GnRH agonists and antagonists, the latter being a fairly new drug with limited data in individual countries.

AB - One of the more recently investigated adverse long‐term side effects of gonadotropin‐releasing hormone (GnRH) agonists for prostate cancer (PCa) is cardiovascular disease (CVD). Studies suggest lower risk of CVD following GnRH antagonists (degarelix) than GnRH agonists. This protocol describes precise codes used to extract variables from five European databases for a study that compares risk of CVD following GnRH agonists and antagonists for PCa.PCa men on primary GnRH agonists or antagonists were identified from the UK THIN (The Health Improvement Network) database, National Health Service (NHS) Scotland, Belgian Cancer Registry (BCR), Dutch PHARMO Database Network and French National Database (SNIIRAM). Cohort entry was defined as date of treatment initiation. CVD event was defined as any first incident or fatal CVD after cohort entry. Readcodes in THIN and ICD codes in NHS Scotland, BCR, PHARMO and SNIIRAM were used to extract variables. Risk of Bias in Non‐randomised studies of Interventions (ROBINS‐I) tool was used to assess the potential risk of biases in this study. 51 572 men with a median follow‐up time of 2 years started on GnRH agonists and 2 417 men with a median follow‐up time of 1 year started on GnRH antagonists between 2010 and 2017 in the UK, Scotland, Belgium, the Netherlands and France. Data from five countries improved the study power and internal validity required to compare risk of CVD between GnRH agonists and antagonists, the latter being a fairly new drug with limited data in individual countries.

KW - GnRH agonists

KW - GnRH antagonists

KW - cardiovascular disease

KW - prostate cancer

KW - real-world evidence

UR - http://www.scopus.com/inward/record.url?scp=85063408857&partnerID=8YFLogxK

U2 - 10.1111/fcp.12454

DO - 10.1111/fcp.12454

M3 - Article

SN - 0767-3981

VL - 33

SP - 479

EP - 499

JO - Fundamental and Clinical Pharmacology

JF - Fundamental and Clinical Pharmacology

IS - 4

M1 - FCP 12454

ER -