Tadalafil and modifications in peak systolic velocity (Doppler spectrum dynamic analysis) in the cavernosal arteries of patients with type 2 diabetes after continuous tadalafil treatment.

AIM

In this study peak systolic velocity (PSV) was measured by penile duplex Doppler spectrum dynamic analysis in diabetic patients with erectile dysfunction (ED) administered continuous treatment with tadalafil for 3 months in a weekly regimen (Monday-Wednesday-Friday). Responses to the Structured Interview on Erectile Dysfunction (SIEDY) questionnaire and hormonal blood levels (LH, testosterone, prolactin) were studied before and after treatment.

METHODS

The study sample was 20 diabetic patients (mean age 60 years; range 55-65) with organic vascular arterial ED at enrollment into the study. All patients were eligible for receiving tadalafil. Patients were randomly assigned to 2 different treatment groups according to a computer-generated list. The first random set of numbers was assigned to group A, the second to group B. Group A (n=10) received tadalafil 20 mg per os on demand for 3 months (Cialis, Lilly ICOS; London, UK). Group B (n=10) received tadalafil 20 mg per os on weekly fixed days (Monday-Wednesday-Friday) for 3 months. All patients underwent duplex penile sonographic dynamic evaluation after intracavernosal injection of alprostadil 20 microg (Caverject, Pharmacia SpA; Milan, Italy); SIEDY questionnaire responses and changes in blood hormonal levels (LH, testosterone, prolactin) before and after treatment were compared.

RESULTS

Increased PSV at 10 min and 20 min after alprostadil administration was found in 30% of Group A patients and in 60% of Group B patients. In 40% of Group B patients, the increase in PSV was so significant as to justify reclassification to a less severe diagnostic category (Benson classification) in vascular profile. No changes in hormonal levels after treatment were found in either group. Analysis of the questionnaires showed a more marked reduction in the global total scores in Group B, with a greater frequency and a clearer improvement in global scores.

CONCLUSIONS

This study on a group of 20 patients with organic vascular arterial ED disclosed at least 2 basic aspects: 1) a higher percentage of Group B patients (fixed-day treatment regimen) showed a greater improvement in PSV than the controls; 40% of these patients were reclassified according to the Benson classification; 2) within the context of a clinical study, monitoring and supportive care to increase the frequency and quality of sexual intercourse led to a resumption of and a greater interest in sexual activity. This finding cannot be explained by changes in hormonal levels; instead, there appeared a sort of effect placebo that the continuous therapy, like conventional treatment for other health reasons, had on the patient.