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One of the more recently investigated adverse long‐term side effects of gonadotropin‐releasing hormone (Gn RH ) agonists for prostate cancer ( PC a) is cardiovascular disease ( CVD ). Studies suggest lower risk of  CVD  following Gn RH  antagonists (degarelix) than Gn RH  agonists. This protocol describes precise codes used to extract variables from five European databases for a study that compares risk of  CVD  following Gn RH  agonists and antagonists for  PC a.   PC a men on primary Gn RH  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 Gn RH  agonists and 2 417 men with a median follow‐up time of 1 year started on Gn RH  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 Gn RH  agonists and antagonists, the latter being a fairly new drug with limited data in individual countries.

fundamental and clinical pharmacology

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