Am Fam Physician. 2010;81(9):1158-1159
Guideline source: American College of Physicians
Literature search described? Yes
Evidence rating system used? Yes
Published source: Annals of Internal Medicine, November 3, 2009
Available at: http://www.annals.org/content/151/9/639.full
Endorsed by the AAFP, August 2011.
Erectile dysfunction (ED) is common and affects men of all ages. As the general population ages and life expectancy increases, ED is anticipated to be a major health care burden. In 1995, more then 152 million men experienced ED. By 2025, the prevalence is expected to increase to approximately 322 million, with costs estimated to reach $15 billion if all men get treatment. Therefore, the American College of Physicians (ACP) created a guideline on hormone testing and pharmacologic treatment of ED.
Diagnostic Hormone Tests
The occurrence of low total and free testosterone levels, and hyperprolactinemia in men with ED varied across studies evaluated. Overall, 12.5 to 35 percent of men studied had low testosterone levels (less than 288 ng per dL [9.99 nmol per L]). This inconsistency may be because of differences between the studies, including population characteristics, measurement methods, and diagnostic criteria. Evidence was insufficient to verify if men with ED had a higher prevalence of hypogonadism or hyperprolactinemia compared with men without ED; therefore, the value of routine hormone testing is uncertain.
Randomized controlled trials showed that phosphodiesterase type 5 (PDE5) inhibitors improved successful sexual intercourse. Approximately 69 percent of persons taking sildenafil (Viagra) had successful attempts versus 36 percent with placebo; 68 percent had successful attempts with vardenafil (Levitra) versus 35 percent with placebo; and 69 percent had successful attempts with tadalafil (Cialis) versus 33 percent with placebo. Sildenafil, vardenafil, and tadalafil also improved erections compared with placebo. Men with specific conditions (e.g., diabetes mellitus, depression, cardiovascular disease, prostate cancer, multiple sclerosis, schizophrenia, liver failure, renal failure) who took PDE5 inhibitors experienced improved erections compared with placebo. Erectile functioning was improved with higher doses of sildenafil (50 mg versus 25 mg) and vardenafil (20 mg versus 10 mg versus 5 mg), but not tadalafil.
Sildenafil was found to be more effective at improving erectile function, frequency of penile penetration or erectile maintenance, and percentage of successful sexual intercourse attempts compared with non-PDE5 inhibitor treatments, such as sublingual apomorphine (Apokyn), psychotherapy, continuous positive airway pressure, phentolamine, and alfuzosin (Uroxatral). Compared with sildenafil alone, sildenafil in combination with other ED therapies (e.g., psychotherapy, dihydroergotamine [Migranal], cabergoline, atorvastatin [Lipitor], quinapril [Accupril], alfuzosin) showed greater improvement in erectile function and frequency of penile penetration or maintenance of erection.
There was insufficient evidence to determine if sildenafil was more effective than tadalafil; if testosterone was more effective than placebo; or if a PDE5 inhibitor in combination with testosterone was more effective than a PDE5 inhibitor plus placebo in improving erections or successful sexual intercourse.
Men taking PDE5 inhibitors are more likely to have at least one adverse event compared with men taking placebo. Common adverse effects include headache, flushing, rhinitis, and dyspepsia, and less common adverse effects include visual disturbances, myalgia, diarrhea, vomiting, dizziness, and chest pain. Sildenafil was associated with fewer adverse effects than non-PDE5 inhibitors (with and without PDE5 inhibitors). Sildenafil, tadalafil, and vardenafil did not vary in adverse events. Adverse events did not differ between oral or gel testosterone and placebo. Incidence of adverse events was low and did not differ between sildenafil alone and sildenafil combined with patch, gel, or oral testosterone.
Among 4 million veterans at least 50 years of age, PDE5 inhibitors were not associated with an increased risk of nonarteritic anterior ischemic optic neuropathy (NAION), but they were associated with an increased risk of possible NAION. Nitrate treatment is a contraindication to treatment with oral PDE5 inhibitors.
Physicians should initiate PDE5 inhibitor treatment in men who want treatment for ED and who do not have a contraindication to PDE5 inhibitors. PDE5 treatment for ED showed a statistically significant improvement in sexual intercourse and erectile function. Improvement in erectile function was related to higher doses of sildenafil and vardenafil, but the higher doses also were associated with a higher risk of adverse effects. Use of nitrates is contraindicated with PDE5 inhibitor use.
Physicians should base PDE5 inhibitor choice on patient preference, including ease of use, cost, and adverse effects. There is insufficient evidence to determine the effectiveness and adverse effects of various PDE5 inhibitors; therefore, patient preference, ease of use, and cost are reasonable criteria to use in selecting treatment.
The ACP does not recommend for or against the routine use of hormone blood tests or hormone treatment in the management of ED. Evidence is inconclusive regarding the effectiveness of hormone treatment for ED. Physicians should make decisions to measure hormone levels based on clinical presentation (e.g., decreased libido, premature ejaculation, fatigue) and physical findings (e.g., testicular or muscular atrophy) that are suggestive of hormone abnormality.