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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
Author(s) -
George Gincy,
Scailteux LucieMarie,
Garmo Hans,
Balusson Frédéric,
Cardwell Christopher,
Coster Greet De,
Schutter Harlinde De,
Kuiper Josephina G.,
McMenamin Úna,
Verbeeck Julie,
Van Hemelrijck Mieke
Publication year - 2019
Publication title -
fundamental and clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.655
H-Index - 73
eISSN - 1472-8206
pISSN - 0767-3981
DOI - 10.1111/fcp.12454
Subject(s) - medicine , prostate cancer , database , cohort , pharmacoepidemiology , disease , cohort study , cancer , oncology , pharmacology , medical prescription , computer science
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.