Association between the Prevalence of cardiovascular risk factors and new use of testosterone

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TESTOSTERONE
• Anatomical Therapeutic Chemical (ATC) code:
  (G03BA03) testosterone

  testosterone
• Medical condition to be studied:
  Hypogonadism male

Population studied

• Short description of the study population:
  All male individuals aged 18 years or older in the source population with a first testosterone use during the study period.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  23000

Study design details

• Main study objective:
  To investigate if testosterone is preferentially given to patients at higher risk profile for cardiovascular events.
• Outcomes:
  Estimation of the association between cardiovascular risk factors and initiation of testosterone therapy
• Data analysis plan:
  The study uses a case-control design. Cases will be ascertained using product and Read medical codes indicating testosterone use. Up to five controls will be drawn from the source population for each case, matched on year of birth, history of pathological hypogonadism (primary or secondary) and GP consultation ±30 days of the index day of the respective case. Descriptive statistics of demographic and baseline clinical characteristics on the index day will be presented for cases and matched controls, including lifestyle factors, pathological hypogonadism (primary or secondary), symptoms associated with hypogonadism, comorbidities, comedications and cardiovascular (CV) risk factors. Crude and adjusted odds ratios (OR) with 95% confidence intervals of the association between CV factors and initiation of testosterone therapy will be estimated using conditional logistic regression for matched case-control data. Results will be stratified by history of pathological hypogonadism.