Impact of diabetes mellitus on the severity of erectile dysfunction and response to treatment: analysis of data from tadalafil clinical trials

Abstract

Aims/hypothesis. A retrospective analysis of pooled data from twelve placebo-controlled trials was conducted to characterise the efficacy and safety of tadalafil for the treatment of erectile dysfunction in men with diabetes compared with that in men without diabetes. Methods. Patients were randomly allocated to tadalafil 10 mg, 20 mg, or placebo, taken as needed for 12 weeks. The study population comprised 637 men with diabetes (mean age 57 years) and 1681 men without diabetes (mean age 56 years). Results. At baseline, patients with diabetes had more severe erectile dysfunction than patients without diabetes, with mean International Index of Erectile Function (IIEF) erectile function domain scores of 12.6 and 15.0 respectively (p<0.001). Compared with placebo, tadalafil 10 mg and 20 mg improved all primary efficacy outcomes in both patient groups (p<0.001). Men with diabetes receiving tadalafil 20 mg experienced a mean improvement of 7.4 in their IIEF erectile function domain score against baseline versus 0.9 for placebo (p<0.001). This group reported on average that 53% of their attempts at intercourse were successful, compared with 22% for placebo (p<0.001 for the change from baseline). Baseline IIEF erectile function domain scores correlated inversely with baseline HbA 1 c levels. The responses to tadalafil were similar regardless of levels of baseline glycaemic control, diabetic therapy received, or previous use of sildenafil. Conclusions/interpretation. Despite more severe baseline erectile dysfunction in men with diabetes, tadalafil was efficacious and well tolerated in this population. As reported for other phosphodiesterase 5 inhibitors, the response to tadalafil was slightly lower in men with diabetes than in men without diabetes.

Endothelial microparticles correlate with erectile dysfunction in diabetic men

“…[1][2][3] Furthermore, individuals with diabetes may have other co-morbid conditions that are associated with ED without diabetes, such as renal failure, hypertension and chronic liver disease, making the precise association of diabetes with ED circumstantial under these conditions. On the other hand, our findings that EMP remain the sole predictor of ED in our diabetic subjects with ED, and the evidence that common risk factors, such as hyperlipidemia and hypertension, do not interfere with the association between EMP and ED suggest that EMP may be one important link between endothelial dysfunction and ED.…”

“…1,2 The relative risk of ED increases with diabetes duration, poor glycemic control and the number of other complications present, including microvascular complications such as nephropathy, neuropathy and retinopathy, and macrovascular atherosclerosis. [1][2][3] One common denominator for these diseases is vascular endothelial dysfunction, and ED may be a marker for the potential development of vascular disease including myocardial infarction. [4][5][6] Vascular endothelium plays a pivotal role in pathogenesis of numerous thrombotic and inflammatory disorders.…”

Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?

“…135 In separate trials, the ability of tadalafil to enhance erectile function in men with diabetes (predominantly type II) and ED was confirmed. 136,137 Despite the 637 men with diabetes having more severe ED than a group of 1681 men without diabetes, in the diabetic group, 53% of their attempts at intercourse were successful in the tadalafil group, compared with 22% in the placebo group. 137 Tadalafil, taken on demand, is also effective in the ED following bilateral nerve sparing radical retropubic prostatectomy.…”

“…136,137 Despite the 637 men with diabetes having more severe ED than a group of 1681 men without diabetes, in the diabetic group, 53% of their attempts at intercourse were successful in the tadalafil group, compared with 22% in the placebo group. 137 Tadalafil, taken on demand, is also effective in the ED following bilateral nerve sparing radical retropubic prostatectomy. 138 In combining 2102 men from 11 trials, with a broad spectrum of ED aetiology and various comorbid medical conditions, it was shown that tadalafil (10 or 20 mg) was effective in all subpopulations.…”

Response to treatment with tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline

“…[5][6][7] Studies including patients with comorbid clinical conditions such as hyperlipidemia, hypertension and cardiovascular disease have also delineated the efficacy of tadalafil therapy. 5,8 In addition, numerous clinical trials have been conducted to evaluate response to therapy in various hard-to-treat populations of men with ED, for example, those with diabetes 9 and those who are post prostatectomy. 10 Clinically meaningful responses in these groups of patients have additionally helped to characterize the benefits of therapy.…”