[Efficacy and safety of sildenafil in men with type 2 diabetes mellitus and erectile dysfunction].
BACKGROUND
Erectile dysfunction is a common complication in patients with diabetes mellitus, which impairs quality of life, decreases self-esteem and can affect partners relationships. Sildenafil improves nitric oxide-dependent relaxation of smooth muscle in corpora cavernosa--induced by an increase in cGMP via inhibition of phosphodiesterase 5.


METHODS
Multicenter, randomized, double-blind, placebo-controlled study with flexible doses of sildenafil. The study was performed in 16 centers and recruited a total of 112 subjects with diabetes mellitus who had erectile dysfunction. At the start and end of the study, the following questionnaires were administered: International Index of Erectile Function (IIEF), Global Efficacy Assessment Question and Quality of Life Questionnaire (Fugl-Meyer). Of the 112 initially recruited patients, 92 received treatment, sildenafil in 44 and placebo in 48.


RESULTS
A clear improvement was observed in the capacity to achieve and maintain an erection; 55.3% diabetic patients receiving sildenafil had at least one successful sexual intercourse (15.6% in the placebo group). In addition, significant improvements were seen in other aspects of the sexual activity of treated subjects. Among those treated with sildenafil, 46.3% reported a clear improvement of erections as compared to their baseline conditions (i.e, prior to treatment) vs only 14.9% in the placebo group. The percentage of a successful intercourse clearly increased, from 6 to 49%. Sildenafil was well-tolerated. Side effects were mild and transient.


CONCLUSIONS
Sildenafil is an effective, safe treatment for erectile dysfunction in diabetic patients.
Escobar-Jiménez
Fernando
F
Servicio de Endocrinología, Hospital Universitario San Cecilio. Granada, España. fescobarjimenez@yahoo.com
D000328:Adult; D000368:Aged; D003627:Data Interpretation, Statistical; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011687:Purines; D011788:Quality of Life; D000068677:Sildenafil Citrate; D013450:Sulfones; D011795:Surveys and Questionnaires; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D010919:Placebos; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; D000068677:Sildenafil Citrate