[Androgens and cardiovascular risk: A series of case report in the French and Canadian pharmacovigilance databases]

Abstract

Introduction: Age-related androgenic deficiency (DALA) is a pathology that is increasingly cited in recent publications. The cardiovascular risk of testosterone is debated: present for the FDA, absent for the European Medicines Agency in 2015. Our objective was to analyze the association between androgens and vascular pathologies in adverse reactions reported in pharmacovigilance databases.

Material and method: We conducted a retrospective case series study of the French and Canadian pharmacovigilance databases for the period 2005-2015. Cases were defined as the association of the occurrence of a cardiovascular event (myocardial infarction or stroke) and the presence of testosterone in the treatment of patients.

Results: Of the 10 years analyzed, 12 French cases and 6 Canadian cases (representing 13 MIs and 5 strokes) were recorded in men aged 55 years on average. All were doubtful: differential diagnoses were possible (2.4 confounding conditions on average per patient) and overall cardiovascular risk was high for the majority of cases.

Conclusion: Our study shows a very low report of cardiovascular effects under testosterone, all doubtful. Pending further studies, it seems reasonable to consider the cardiovascular risk of patients who are candidates for hormone therapy for age-related androgen deficiency.

Level of evidence: 3.

Keywords: Androgen deficiency in male aging; Andropause; Cardiovascular events; Pharmacovigilance; Testosterone replacement therapy; Testostérone; Évènement cardiovasculaire.