Phosphodiesterase Type 5 Inhibitors and Priapism: A VigiBase Analysis.
Purpose: To explore the differences among erectile aids (i.e.,
phosphodiesterase type 5 inhibitors [PDE5i] and intracavernousal
drugs) of the relative risk of priapism and identify age groups at risk.
Methods: We queried the World Health Organization global
database of individual case safety reports (VigiBase) for records of the
ADR with sildenafil, tadalafil, avanafil, vardenafil, papaverine, and
alprostadil. Disproportionality analyses (case/non-case approach) were
performed to assess the relative risk of priapism reporting in PDE5i
consumers compared to intracavernousal drug recipients.
Results: From a total of 133,819 ADR events for erectogenic
medications, 632 were priapism (PDE5is: n=550, 0.41%; intracavernousal
drugs: n=82, 9.92%). We observed a strong signal for priapism induction
for intracavernousal drugs than PDE5is (reporting odds ratio
[ROR]=34.7; confidence interval [CI] 95%: 27.12 - 43.94
vs. ROR= 1.38; CI 95%: 1.24 - 1.54). For all PDE5i agents, the
12-17 years age group had the highest highest ROR (ROR=9.49, CI 95%:
3.76 - 19.93) followed by 2-11 years (ROR=4.31, CI 95%: 1.57 - 9.4).
Disproportionality signals for consumers under eighteen for both all
PDE5is as a whole (ROR=4.57, CI 95%: 2.48 - 7.73) and sildenafil
(ROR=4.89, CI 95%: 2.51 - 8.62) were significantly stronger than
individuals eighteen or older (ROR=1.06, CI 95%: 0.93 - 1.21 and
ROR=1.08, CI 95%: 0.91 - 1.26, respectively). Conclusions:
While the overall risk of priapism following the oral administration of
PDE5is is extremely low compared with intracavernousal remedies,
adolescents are at a higher risk of priapism than older men.