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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Burnett, AL; Anele, UA; Trueheart, IN; Strouse, JJ; Casella, JF

Published Date

  • July 2014

Published In

Volume / Issue

  • 127 / 7

Start / End Page

  • 664 - 668

PubMed ID

  • 24680796

Pubmed Central ID

  • 24680796

Electronic International Standard Serial Number (EISSN)

  • 1555-7162

Digital Object Identifier (DOI)

  • 10.1016/j.amjmed.2014.03.019

Language

  • eng

Conference Location

  • United States