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

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.

• Authors: Arthur L Burnett, Uzoma A Anele, Irene N Trueheart, John J Strouse, James F Casella
• Journal: The American journal of medicine (Am J Med) Vol. 127 Issue 7 Pg. 664-8 (Jul 2014) ISSN: 1555-7162 [Electronic] United States
• PMID: 24680796 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Phosphodiesterase 5 Inhibitors
• Piperazines
• Purines
• Sulfones
• Sildenafil Citrate

Topics

• Adolescent
• Adult
• Anemia, Sickle Cell (complications)
• Double-Blind Method
• Humans
• Ischemia (complications, prevention & control)
• Male
• Middle Aged
• Phosphodiesterase 5 Inhibitors (therapeutic use)
• Piperazines (therapeutic use)
• Priapism (etiology, prevention & control)
• Prospective Studies
• Purines (therapeutic use)
• Recurrence
• Sildenafil Citrate
• Sulfones (therapeutic use)
• Young Adult