Testosterone therapy can enhance erectile function response to sildenafil in patients with PADAM: a pilot study.
ABSTRACT Recent studies suggest a direct relationship between free testosterone and cavernous vasodilatation. Some men with erectile dysfunction (ED) associated with PADAM (partial androgen deficiency in aging men) might possibly benefit from testosterone undecanoate therapy (TRT).
To determine the efficacy of testosterone undecanoate in facilitating the erectile response and patient satisfaction with sildenafil in men 40-70 years old with PADAM symptoms.
Prospective study including 40 patients recruited after a sildenafil therapeutic trial. Total testosterone and sex hormone binding globulin (SHBG) were measured to calculate the free androgen index. Prostate specific antigen (PSA) was measured and repeated 2 months after treatment. A rating score was used for PADAM symptoms, and the 5-point abbreviated version of the International Index of Erectile Function (IIEF-5) to assess erectile function. Men failing to respond to sildenafil were randomized into two groups receiving sildenafil plus continuous TRT (group 1ST), and TRT (group 1T) alone. Men partially responding to sildenafil were randomized into two groups receiving sildenafil plus continuous TRT for 2 months (group 2ST), or sildenafil alone (group 2S). Treatment efficacy was assessed by analysis of between-group differences.
Groups 1T, 2S, and 2ST showed significant improvement in PADAM scores (P<0.05, Wilcoxon matched pairs test). Patients receiving both sildenafil plus continuous TRT (groups 1ST and 2ST) showed significant improvement in IIEF-5 scores (P<0.5, paired t-test). No significant changes in serum levels of PSA were detected (paired t-test).
We conclude that TRT appears to be beneficial and safe in facilitating the erectile response and patient satisfaction with sildenafil in men with PADAM symptoms. Androgen supplementation should be carried out cautiously with careful monitoring to avoid possible adverse effects.
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ABSTRACT: Introduction: Men with erectile dysfunction (ED) considered challenging-to-treat with PDE-5 inhibitors (PDE5i) include patients with severe neurological damage (e.g., due to radical prostatectomy), diabetes and severe vascular disease. Another factor that may limit PDE5i efficacy is the age-related decline of testosterone (T), occurring in 3 – 35% of older men depending on different cut-offs chosen. T regulation of PDE5 expression has been accepted as one of the major mechanisms controlling vasodilator mechanisms in penile tissue.Areas covered: We reviewed data regarding the use of T as a salvage therapy in PDE5i nonresponders.Expert opinion: Guidelines recommend that hypogonadal men with ED should commence therapy with PDE5i due to time course effects of T on erection that needs 6 – 12 weeks to occur. The possibility to ‘salvage’ some patients with low T not responding to PDE5i alone by adding T therapy should consider correct cut-off values, plasma T levels attained and androgen receptor (AR) polymorphism. Meta-analyses suggest that T treatment plus PDE5i yielded more effective results in noncontrolled versus controlled studies. We recommend T assay in all men with ED not responsive to PDE5i. Before commencing T treatment, side effects and consequent higher mortality in older frail men have to be avoided.Expert Opinion on Pharmacotherapy 02/2015; 16(5). DOI:10.1517/14656566.2015.1011124 · 3.09 Impact Factor
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ABSTRACT: Currently, phosphodiesterase type 5 (PDE5) inhibitors are the initial treatment option for erectile dysfunction. The reported efficacy of PDE5 inhibitors is about 70%, although it is significantly lower in difficult-to-treat subpopulations. Treatment failures might be due to the severity of the underlying pathophysiology, improper use of medication, unrealistic patient expectations, difficult relationship dynamics, severe performance anxiety, and other psychological problems. Physicians must address these issues to identify true treatment failures attributable to the drugs. This article discusses factors that might affect the response to PDE5 inhibitors and develops a strategy to maximize the overall efficacy of PDE5 inhibitors in initial non-responders to PDE5 inhibitors.04/2013; 31(1):31-5. DOI:10.5534/wjmh.2013.31.1.31
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ABSTRACT: The role of testosterone in erectile dysfunction (ED) is increasingly recognized. It is suggested that assessment of testosterone deficiency in men with ED and symptoms of hypogonadism, prior to first-line treatment, may be a useful tool for improving therapy. In this prospective, observational, and longitudinal study, we investigated the effects of vardenafil treatment as adjunctive therapy to testosterone undecanoate in hypogonadal ED patients who failed to respond to testosterone treatment alone. One hundred twenty-nine testosterone deficient (serum total testosterone ≤3.4 ng/mL) patients aged 56 ± 3.9 years received intramuscular injections of long-acting parenteral testosterone undecanoate at 3-month intervals for 8 months mean follow-up. Scores on the International Index of Erectile Function Questionnaire-five items (IIEF-5) and partner survey scores were compared at baseline and posttreatment with testosterone therapy alone or in combination with vardenafil. Patient baseline demographics and concomitant disease were correlated with patients' IIEF-5 scores. Seventy one (58.2%) responded well to monotherapy within 3 months. Nonresponders had lower testosterone levels and higher rates of concomitant diseases and smoking. Thirty-four of the 51 nonresponders accepted the addition of 20 mg vardenafil on demand. Efficacy assessments were measured by the IIEF-erectile function domain (IIEF-EF, questions 1-5 plus 15, 30 points) and partner self-designed survey at baseline after 4-6 weeks and at study end point. Thirty out of 34 patients responded well to this combination. IIEF-EF Sexual Health Inventory for Men score improved from 12 to 24 (P < 0.0001), and partner survey showed significantly higher satisfaction (P < 0.001). These patients reported spontaneous or nocturnal and morning erections or tumescence. No changes in adverse effects were recorded. These data suggest that combination therapy of testosterone and vardenafil is safe and effective in treating hypogonadal ED patients who failed to respond to testosterone monotherapy. Yassin D-J, Yassin AA, and Hammerer PG. Combined testosterone and vardenafil treatment for restoring erectile function in hypogonadal patients who failed to respond to testosterone therapy alone. J Sex Med **;**:**-**.Journal of Sexual Medicine 11/2013; 11(2). DOI:10.1111/jsm.12378 · 3.15 Impact Factor