Sildenafil citrate for the treatment of erectile dysfunction in men with Type II diabetes mellitus

Aims/hypothesis. Ninety percent of all men with diabetes have Type II (non- insulin-dependent) diabetes mellitus, and erectile dysfunction (ED) is comm on in this patient group. This study evaluated the effects of sildenafil on men with erectile dysfunction and Type II diabetes and compared the result s with glycated haemoglobin concentrations and chronic diabetic complicatio ns. Methods. Patients (mean age, 59 years) in this double-blind, placebo-contro lled trial were randomised to sildenafil (25-100 mg; n = 110) or matching p lacebo (n = 109) for 12 weeks. Primary criteria for efficacy included quest ions 3 (achieving an erection) and 4 (maintaining an erection) from the Int ernational Index of Erectile Function (IIEF, score range, 0-5). Secondary o utcome measures included a global efficacy question (GEQ), patient event lo gs, a life satisfaction checklist, and the remaining IIEF questions. Results. After 12 weeks, the mean scores for questions 3 and 4 had improved significantly in patients receiving sildenafil (3.42 +/- 0.23 and 3.35 +/- 0.24) compared with placebo (1.86 +/- 0.22 and 1.84 +/- 0.23; p < 0.0001). Similarly, the GEQ score was higher in the sildenafil (64.6%) than the pla cebo group (10.5%). Even when correlating efficacy with glycated haemoglobi n concentrations (less than or equal to 8.3% or > 8.3%, the median concentr ation found in this study) or the number of diabetic complications (0 or gr eater than or equal to 1), the mean scores for the GEQ and questions 3 and 4 from the IIEF remained higher for all the sildenafil groups compared with the placebo groups (P < 0.0001). Conclusion/interpretation. Sildenafil was well-tolerated and effective in i mproving erectile dysfunction in men with Type II diabetes, even in patient s with poor glycaemic control and chronic complications.