What are the guidelines for use of PDE5 inhibitors in the treatment of erectile dysfunction (ED)?

Updated: Oct 14, 2020
  • Author: Edward David Kim, MD, FACS; Chief Editor: Edward David Kim, MD, FACS  more...
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In current practice, PDE5 inhibitors are the most commonly used treatment for ED. [85] This drug class consists of sildenafil, vardenafil, tadalafil, and avanafil. Sildenafil was the first in this series of PDE inhibitors; avanafil is the newest, having been approved by the US Food and Drug Administration (FDA) in 2012. In a study of 390 men with diabetes and erectile dysfunction, avanafil was found to be a safe and effective treatment as early as 15 minutes and more than 6 hours after dosing. [86]

Guidelines from the American Urological Association (AUA) recommend offering PDE5 inhibitors as first-line therapy for ED unless the patient has contraindications to their use (eg, concurrent organic nitrate therapy). The AUA notes that insufficient evidence exists to support the superiority of any one of these agents over the others. [1]  European guidelines suggest that the choice of drug (short- versus long-acting) depend on the frequency of intercourse (occasional use or regular therapy, 3-4 times weekly) and the patient’s personal experience. [87]

The AUA warns that PDE5 inhibitors can cause mild transient systemic vasodilation, which may be aggravated by alpha-blocking agents. Consequently, the guidelines advise that vardenafil and tadalafil, at any dose, and sildenafil at 50 mg and 100 mg doses should be administered with caution in patients who are taking alpha blockers. [1]

In patients with ED that is refractory to therapy with oral PDE5 inhibitors, one of these agents can be combined with an injection of prostaglandin E1 (PGE1; alprostadil). [3] Gutierrez et al demonstrated that this combination was more effective than either one alone. [88] The combination of a PDE5 inhibitor with intraurethral PGE1 has also proved successful.

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