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Phosphodiesterase Type 5 Inhibitors and Priapism: A VigiBase Analysis.
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  • Behzad Abbasi,
  • Nathan M. Shaw,
  • Jason L. Lui,
  • Nizar Hakam,
  • Behnam Nabavizadeh,
  • Benjamin N. Breyer
Behzad Abbasi
University of California San Francisco
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Nathan M. Shaw
University of California San Francisco
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Jason L. Lui
University of California San Francisco
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Nizar Hakam
University of California San Francisco
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Behnam Nabavizadeh
University of California San Francisco
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Benjamin N. Breyer
University of California San Francisco

Corresponding Author:[email protected]

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Abstract

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.
13 Mar 2023Submitted to Pharmacoepidemiology and Drug Safety
16 Mar 2023Submission Checks Completed
16 Mar 2023Assigned to Editor
16 Mar 2023Review(s) Completed, Editorial Evaluation Pending
20 Mar 2023Reviewer(s) Assigned
31 May 2023Editorial Decision: Revise Major
31 Jul 20231st Revision Received
31 Jul 2023Submission Checks Completed
31 Jul 2023Assigned to Editor
31 Jul 2023Review(s) Completed, Editorial Evaluation Pending
12 Sep 2023Editorial Decision: Revise Minor
22 Sep 20232nd Revision Received
22 Sep 2023Submission Checks Completed
22 Sep 2023Assigned to Editor
22 Sep 2023Review(s) Completed, Editorial Evaluation Pending
02 Oct 2023Editorial Decision: Revise Minor
09 Oct 20233rd Revision Received
09 Oct 2023Submission Checks Completed
09 Oct 2023Assigned to Editor
09 Oct 2023Review(s) Completed, Editorial Evaluation Pending
14 Oct 2023Editorial Decision: Accept