Oral sildenafil in the treatment of erectile dysfunction in diabetic men: a randomized double-blind and placebo-controlled study.

Department of Urology, Military University of Medical Sciences, P.O. Box 19395-1849, Tehran, Iran.
Journal of Diabetes and its Complications (Impact Factor: 3.01). 01/2004; 18(4):205-10.
Source: PubMed


To determine the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction (ED) in diabetic men.
In a randomized, double-blind, placebo-controlled, and fixed-dose study, a total of 282 men (mean age, 46.4 years) with ED (mean duration, 3.6 years) and diabetes (mean duration, 11 years) were randomly assigned to receive 100 mg sildenafil (n=144) or placebo (n=138) approximately 1 h before planned sexual activity, but not more than once daily, for 16 weeks. The efficacy of two treatments was assessed using responses to the International Index of Erectile Function (IIEF) questionnaire.
Two hundred sixty-two (93%) of men completed the study (134/144 in the sildenafil group, 128/138 in the placebo group). Positive clinical results were obtained in 68 (51%) of 134 patients in the sildenafil group compared with 14 (11%) of 128 patients in the placebo group (P<.003). Fifty-nine percent of the patients reported at least one successful attempt at sexual intercourse in the sildenafil group as compared with 21% successful attempts for the placebo group (P<.002). Drug-related adverse effects occurred in 32 (22%) of 144 patients taking sildenafil and 4 (3%) of 138 patients receiving placebo. The most common adverse events were headache (20% sildenafil, 2% placebo), flushing (19% sildenafil, 0% placebo), dyspnea (9% sildenafil, 2% placebo), rhinitis (6% sildenafil, 0% placebo), and cardiovascular effects (7% sildenafil, 0% placebo). Of patients taking sildenafil, four (2.7%) developed new chest pains, with documented myocardial infarction in two.
Oral sildenafil is a moderately effective treatment for ED in men with diabetes. The response rate was lower and cardiovascular events were higher than previously reported in nondiabetic patients.

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    • "ED in men with DM has a multifactorial etiology that includes psychogenic factors, autonomic neuropathy, vascular disease, and drug intake. Several studies have demonstrated a high prevalence (35-75%) of ED in men with DM [4]. In patients with diabetes and hyperglycemia, the interaction between advanced glycation end products and advanced glycation end product receptors generates oxidative stress, vascular inflammation, and thrombosis, which contribute to vasculopathy [8]. "
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    ABSTRACT: We studied the relative importance of high-sensitivity C-reactive protein (hs-CRP) concentrations in patients with erectile dysfunction (ED) and diabetes and determined whether the hs-CRP level predicts the response to treatment with 5 mg tadalafil once daily. We enrolled 102 men (aged 40-60 years) with diabetes and ED. All patients completed the International Index of Erectile Function (IIEF) questionnaire and were given 5 mg tadalafil daily. The IIEF and serum hs-CRP levels in patients and healthy controls and in patient responders and nonresponders to 5 mg tadalafil once daily were compared. Median age was 53.2 years (range, 45 to 62 years) in patients and 55.6 years (range, 47 to 64 years) in healthy controls (p=0.158). The median duration of diabetes was 54.3 months (range, 34 to 70 months). The median IIEF and hs-CRP level were 12.1 (range, 5 to 20) and 0.21 mg/dL (range, 0.05 to 0.6 mg/dL) in patients and 28.2 (range, 13 to 31) and 0.09 mg/dL (range, 0.04 to 0.2 mg/dL) in the controls, respectively (pIIEF=0.000, pCRP=0.031). After tadalafil treatment, 71 patients (69.6%) achieved an erection sufficient for sexual intercourse, whereas 31 (30.4%) did not. The median age of the tadalafil nonresponders was 56.2 years (range, 45 to 64 years) and that of the responders was 51.3 years (range, 42 to 62 years; p=0.065). Median hs-CRP levels were 0.31 mg/dL (range, 0.18 to 0.62 mg/dL) in nonresponders and 0.14 mg/dL (range, 0.09 to 0.4 mg/dL) in responders, respectively (p=0.028). Serum hs-CRP was significantly higher in patients with ED and diabetes mellitus than in patients without ED. A significant correlation was observed between serum hs-CRP levels, the degree of ED, and responsiveness to tadalafil.
    Korean journal of urology 12/2013; 54(12):858-64. DOI:10.4111/kju.2013.54.12.858
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    ABSTRACT: Descripción: El American College of Physicians desarrolló estas guías clínicas para presentar la evidencia disponible sobre la evaluación hormonal y el tratamiento farmacológico de la disfunción eréctil. Las terapéutica farmacológica actual incluye a los inhibidores de la 5-fosfodiesterasa (PDE-5) como el sildenafil, vardenafil, tadalafil, mirodenafil y udenafil, así como el tratamiento hormonal. Métodos: La literatura publicada sobre este tema fue identificada usando MEDLINE (1966 a mayo del 2007), EMBASE (1980 a la semana 22 del 2007), el Registro Central de Estudios Controlados Cochrane (segunda trimestre del 2007), PsycINFO (1985 a junio del 2007), AMED (1985 a junio del 2007), y SCOPUS (2006). La búsqueda bibligráfica fue actualizada buscando artículos en MEDLINE y EMBASE publicados entre mayo 2007 y abril 2009. Las búsquedas se limitaron a publicaciones en idioma inglés. Esta guía clínica establece el nivel de evidencia y el grado de recomendación utilizando el sistema de graduación de las guías clínicas del American College of Physicians.
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