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

Abstract

Diabetes mellitus is very common, with Type II (noninsulin-dependent) diabetes mellitus accounting for 90 % to 95 % of the diagnosed patients [1]. A frequent complication of diabetes is erectile dysfunction (ED), with an estimated prevalence of 20 % to 85 % (ranging from mild to complete ED) [2], which occurs at an earlier age than in non-diabetic men. In the Massachusetts Male Aging study [3], men with treated diabetes had an age-adjusted prevalence of complete ED (no erections) of 28 %, which was approximately three times higher than the prevalence of complete ED observed in the entire sample of men (10 %).Although ED in patients with diabetes is often complex and can be caused by several mechanisms Diabetologia (2001) Abstract Aims/hypothesis. Ninety percent of all men with diabetes have Type II (non-insulin-dependent) diabetes mellitus, and erectile dysfunction (ED) is common in this patient group. This study evaluated the effects of sildenafil on men with erectile dysfunction and Type II diabetes and compared the results with glycated haemoglobin concentrations and chronic diabetic complications. Methods. Patients (mean age, 59 years) in this double-blind, placebo-controlled trial were randomised to sildenafil (25±100 mg; n = 110) or matching placebo (n = 109) for 12 weeks. Primary criteria for efficacy included questions 3 (achieving an erection) and 4 (maintaining an erection) from the International Index of Erectile Function (IIEF, score range, 0±5). Secondary outcome measures included a global efficacy question (GEQ), patient event logs, 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 placebo group (10.5 %). Even when correlating efficacy with glycated haemoglobin concentrations ( £ 8.3 % or > 8.3 %, the median concentration found in this study) or the number of diabetic complications (0 or ³ 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 improving erectile dysfunction in men with Type II diabetes, even in patients with poor glycaemic control and chronic complications. [Diabetologia (2001

Sildenafil citrate: lessons learned from 3 years of clinical experience

“…11 The most recently reported study involving patients with type 2 diabetes reports a 64.6% response rate to sildenafil compared with a 10.5% response rate in diabetic patients receiving placebo. 13 Sildenafil was effective in improving ED in these studies, even in cases of poor glycemic control; the response rate, however, for patients with multiple chronic complications was lower, reflecting the severity of the disease. A retrospective analysis of combined data from 11 double-blind, placebo-controlled trials of sildenafil (which included 152 and 822 patients with type 1 and 2 diabetes, respectively, and 1693 patients without diabetes) confirmed that although treatment response was lower for patients with diabetes compared with those without diabetes, the efficacy of sildenafil was similar for men with type 1 and type 2 diabetes, with more than three times as many men receiving sildenafil reporting significant improvement in erectile function compared with those receiving placebo.…”

Effect of combination endothelial nitric oxide synthase gene therapy and sildenafil on erectile function in diabetic rats

“…15,35,36 However, sildenafil does not have the same efficacy in improving erectile function as measured by the International Index of Erectile Function in diabetic patients when compared to other ED etiologies. 16 Sildenafil requires at least partial function of NANC penile nerves to be effective, and, therefore, men who have DM or have undergone non-nerve-sparing radical prostatectomy are less likely to respond.…”

Specific aspects of erectile dysfunction in endocrinology

“…Sildenafil has been well characterized in diabetic patients, with success rates of 56-67% in this population, compared with 10-29% with placebo. [16][17][18] For most patients the doses are 25, 50 or 100 mg 1 h before intercourse, and can be taken only once daily. Sildenafil has no effect in the absence of sexual stimulation, and is contraindicated in patients who are taking nitrates for cardiovascular disease.…”