Randomized controlled trial of sildenafil for preventing recurrent ischemic priapism in sickle cell disease

Arthur L. Burnett, Uzoma A. Anele, Irene N. Trueheart, John J. Strouse, James F. Casella

Research output: Contribution to journalArticlepeer-review

Abstract

Background Successful preventive therapy for ischemic priapism, a disorder of penile erection with major physical and psychologic consequences, is limited. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of sildenafil by a systematic dosing protocol to prevent recurrent ischemic priapism associated with sickle cell disease. Methods Thirteen patients with sickle cell disease reporting priapism recurrences at least twice weekly were randomized to receive sildenafil 50 mg or placebo daily, unassociated with sleep or sexual activity, for 8 weeks, followed by open-label use of this sildenafil regimen for an additional 8 weeks. Results Priapism frequency reduction by 50% did not differ between sildenafil and placebo groups by intention-to-treat or per protocol analyses (P = 1.0). However, during open-label assessment, 5 of 8 patients (62.5%) by intention-to-treat analysis and 2 of 3 patients (66.7%) by per protocol analysis met this primary efficacy outcome. No significant differences were found between study groups in rates of adverse effects, although major priapism episodes were decreased 4-fold in patients monitored "on-treatment." Conclusions Sildenafil use by systematic dosing may offer a strategy to prevent recurrent ischemic priapism in patients with sickle cell disease.

Original languageEnglish (US)
Pages (from-to)664-668
Number of pages5
JournalAmerican Journal of Medicine
Volume127
Issue number7
DOIs
StatePublished - Jul 2014

Keywords

  • Erectile dysfunction
  • Erection
  • Nitric oxide
  • Phosphodiesterase type 5

ASJC Scopus subject areas

  • Medicine(all)

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