Testosterone Replacement Therapy (TRT) and Risk of Acute Myocardial Infarction (AMI): An Administrative Healthcare Claims Study (F1D-MC-B006)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TESTOSTERONE
• Medical condition to be studied:
  Acute myocardial infarction

Population studied

• Short description of the study population:
  Male patients aged 18 years or older with at least 12 months (365 days) of continuous enrollment in a health plan prior to the index date and who had at least 1 prescription for testosterone products, at least 1 prescription for PDE5i, or at least 1 diagnosis of hypogonadism condition related International Classification of Diseases, Ninth Revision (ICD 9) codes.
• 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:
  10462

Study design details

• Main study objective:
  Primary objective: To evaluate the incidence of AMI among patients treated with TRT (any testosterone prescription and major testosterone prescriptions) relative to a propensity score matched untreated hypogonal patients cohort.
• Outcomes:
  Acute myocardial infarction
• Data analysis plan:
  The baseline characteristics for the pre-matched population will be presented. A summary of baseline characteristics will also be presented for those subjects who are not included in the propensity score-matched analysis. The primary analysis of this protocol is to compare AMI risk between propensity score matched TRT treated patients versus untreated patients, using a Cox proportional hazard model. The secondary comparison of the AMI risk between propensity score matched TRT-treated patients vs. PDE5i-treated patients. The following subgroup analyses will be conducted:1) TRT routes of administration (gel/topical, patch, injectable, non-specified),2) By prior cardiovascular condition (as listed in Table 9.2),3) By age group (18-64 years, ≥65 years),Additional sensitivity analysis may be performed on a post hoc basis.

Documents

Study results

Non_interventional PASS Final Study Report_11Apr2016_for encepp