A phase II, single-blind, randomized, crossover evaluation of the safety and efficacy of avanafil using visual sexual stimulation in patients with mild to moderate erectile dysfunction.

OBJECTIVE: To evaluate the safety, efficacy and time course of three doses of avanafil (50 mg, 100 mg and 200 mg) compared with sildenafil 50 mg or placebo, given in conjunction with visual sexual stimulation (VSS) videos in men with mild to moderate erectile dysfunction (ED). PATIENTS AND METHODS: Male patients, 35-70 years of age, with mild to moderate ED of ≥6 months duration, were included in the study. During the course of the study, each patient received placebo, active control (sildenafil 50 mg), and one dose of avanafil (50 mg, 100 mg or 200 mg), all administered in random order at least 72 h apart. RigiScan® (Dacomed Corp., Minneapolis, MN, USA) monitoring was used in conjunction with 20-min VSS videos (20, 60, and 100 min after dosing) to determine the duration of and time to ≥60% penile rigidity, maximum rigidity, tumescent activity units (TAUs), rigidity activity units (RAUs), and responses to the five-point Erection Assessment Scale. Safety assessments included adverse events (AEs), vital sign changes in response to dosing, laboratory results (complete blood counts, chemistry panel, prostate-specific antigen, serum testosterone, prothrombin time and urine analysis) and physical examination findings. RESULTS: Eighty-three patients were randomized and received at least one dose of study medication; 82 patients completed the study. Peak response to avanafil occurred in the early interval (20-40 min after dosing), while peak response to sildenafil occurred either in the middle (60-80 min) or late (100-120 min) intervals after dosing. Results were qualitatively similar for all other efficacy endpoints. During the 20-40-min interval, the majority of values for TAUs and RAUs with the avanafil 50-mg, 100-mg and 200-mg treatments were significantly superior to placebo (P < 0.05). Avanafil treatment was generally well tolerated; facial flushing (7-15%) was the most commonly observed AE, and no visual disturbances were reported. CONCLUSION: A favourable safety profile and improvement in sexual function, coupled with rapid onset of action and durability of effect, make avanafil an attractive option for males with ED, especially in the setting of on-demand treatment.

Erectile dysfunction after radical prostatectomy: treatment options.

Erectile dysfunction is a common problem after radical prostatectomy, with almost all men experiencing this complication for at least a short period after such surgery. There is evidence that early use of phosphodiesterase type 5 inhibitors, intracavernous vasoactive drugs, intraurethral alprostadil or vacuum devices can improve the recovery of postoperative erectile function. The same therapeutic modalities can be used to treat erectile dysfunction after radical prostatectomy. Physicians must be active and counsel patients and partners to improve adherence to penile rehabilitation or erectile dysfunction treatment.

Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians.

DESCRIPTION: The American College of Physicians developed this guideline to present the available evidence on hormonal testing in and pharmacologic management of erectile dysfunction. Current pharmacologic therapies include phosphodiesterase-5 (PDE-5) inhibitors, such as sildenafil, vardenafil, tadalafil, mirodenafil, and udenafil, and hormonal treatment. METHODS: Published literature on this topic was identified by using MEDLINE (1966 to May 2007), EMBASE (1980 to week 22 of 2007), Cochrane Central Register of Controlled Trials (second quarter of 2007), PsycINFO (1985 to June 2007), AMED (1985 to June 2007), and SCOPUS (2006). The literature search was updated by searching for articles in MEDLINE and EMBASE published between May 2007 and April 2009. Searches were limited to English-language publications. This guideline grades the evidence and recommendations by using the American College of Physicians' clinical practice guidelines grading system. RECOMMENDATION 1: The American College of Physicians recommends that clinicians initiate therapy with a PDE-5 inhibitor in men who seek treatment for erectile dysfunction and who do not have a contraindication to PDE-5 inhibitor use (Grade: strong recommendation; high-quality evidence). RECOMMENDATION 2: The American College of Physicians recommends that clinicians base the choice of a specific PDE-5 inhibitor on the individual preferences of men with erectile dysfunction, including ease of use, cost of medication, and adverse effects profile (Grade: weak recommendation; low-quality evidence). RECOMMENDATION 3: The American College of Physicians does not recommend for or against routine use of hormonal blood tests or hormonal treatment in the management of patients with erectile dysfunction (Grade: insufficient evidence to determine net benefits and harms).

Oral phosphodiesterase-5 inhibitors and hormonal treatments for erectile dysfunction: a systematic review and meta-analysis.

BACKGROUND: Erectile dysfunction (ED) is a common male sexual disorder. The relative benefits and harms of pharmacologic therapies for ED, as well as the value of hormonal testing in men with ED, are uncertain. PURPOSE: To evaluate the efficacy and harms of oral phosphodiesterase-5 (PDE-5) inhibitors and hormonal treatments for ED and assess the effect of measuring serum hormone levels on treatment outcomes for ED. DATA SOURCES: English-language studies from MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, AMED, and SCOPUS through April 2009. Trial reference lists also were scanned. STUDY SELECTION: Randomized, controlled trials (RCTs) of oral PDE-5 inhibitors and hormonal treatment for ED, and observational studies reporting measurement of serum hormone levels, prevalence of hormonal abnormalities, or both in men with ED. DATA EXTRACTION: Two independent reviewers abstracted data on study, participant, and treatment characteristics; efficacy and harms outcomes; and prevalence of hormonal abnormalities. DATA SYNTHESIS: Data, primarily from short-term trials (

[Tadalafil for erectile dysfunction: outstanding efficacy for 36 hours].

Phosphodiesterase type 5 (PDE5) inhibitors are first-line oral medication for erectile dysfunction (ED). Compared with the other two PDE inhibitors (sildenafil and vardenafil), tadalafil is characterized by rapid onset, convenient dosing, excellent efficacy, especially the 36-hour duration of effectiveness deriving from long elimination half-life, allowing for more flexibility to scheduled medication. Higher satisfaction of patients and their partners with tadalafil is mainly due to such psychosocial benefits as decreased time concerns. Tadalafil is well-tolerated, consistent with the principle of safely, effectiveness and convenient dosing and is becoming the favorite choice of ED patients and their partners.

Phosphodiesterase type 5 inhibitors, visual changes, and nonarteritic anterior ischemic optic neuropathy: is there a link?

Nonarteritic anterior ischemic optic neuropathy (NAION) is the most common acute optic neuropathy and one of the most common causes of sudden vision loss in the elderly. Recently, NAION has been associated with the use of phosphodiesterase type 5 inhibitors (PDE5i) in men with erectile dysfunction (ED). A causal relationship could not be established given the large number of men safely using PDE5i and the limited number of NAION cases reported in these men. ED and NAION share common risk factors; therefore, some men with ED should be expected to develop NAION. However, sudden vision loss or decreased vision in one or both eyes demands immediate cessation of PDE5i use and urgent patient assessment. No causal relationship between PDE5i and the development of NAION exists for the moment, yet physicians should be aware of a possible adverse reaction and inform patients accordingly.