An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction.

AIM: Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes. METHODS: This was a 52-week, open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; '100/200-mg' group) or 50 mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3) and erectile function domain score per the International Index of Erectile Function (IIEF-EF). RESULTS: Some 712 patients enrolled; 686 were included in the intent to treat population and contributed to the data. All primary end points showed sustained improvement. SEP2 and SEP3 success rates improved from 44% to 83% and from 13% to 68% (100-mg group) and from 43% to 79% and from 11% to 66% (100/200-mg group), respectively. Mean IIEF-EF domain scores improved from 13.6 to 22.2 (100-mg group) and from 11.9 to 22.7 (100/200-mg group). Avanafil was effective in some patients ≤ 15 min and > 6 h postdose. Sixty-five per cent (112/172) of 'nonresponders' to avanafil 100 mg responded to the 200-mg dose. The most common (≥ 2%) treatment-emergent adverse events were headache, flushing, nasopharyngitis and nasal congestion; < 3% of patients discontinued therapy because of adverse events. CONCLUSIONS: The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.

Metastatic Sertoli cell carcinoma of the testis.

Metastatic Sertoli cell tumor is a very rare and deadly disease accounting for approximately 1% of all testicular carcinomas. With fewer than 30 cases reported in the literature, there has not been a uniform treatment regimen with good results. Retroperitoneal lymph node dissection, chemotherapy, and radiation therapy in combination appear to offer the best outcome. This report describes the occurrence of this rare tumor in a 38-year-old man 2 years after left orchiectomy.

Early detection of stage A prostate carcinoma: combined use of prostate-specific antigen and transrectal ultrasonography.

We prospectively studied 103 men who had normal results on digital prostate examinations but had bladder outlet obstruction secondary to prostatic hypertrophy and needed transurethral prostatectomy. All men underwent a preoperative transrectal ultrasonographic examination of the prostate and prostate-specific antigen (PSA) level determination. A total of 30 cancers were ultimately detected, 22 (73%) of which were detected preoperatively by either an abnormal ultrasonogram or elevated PSA levels (or both). Eight of these men were spared transurethral prostatectomy and had definitive treatment based on transrectal biopsy and appropriate staging evaluation. For PSA and ultrasonography combined, the sensitivities and negative predictive values for cancer (92% and 94%, respectively) were superior to the specificities and positive predictive values (71% and 64%, respectively). The combined use of both studies is recommended to rule out cancer in candidates for prostatectomy but not to routinely screen the general male population older than 40 years.

Priapism associated with intranasal cocaine abuse.

Cocaine abuse has escalated to epidemic proportions in the United States. In addition to the social and economic problems associated with the recreational use of this agent, a variety of medical complications have been reported. The occurrence of priapism with intranasal use has not been documented previously. We report a case of priapism secondary to intranasal cocaine abuse and describe the possible neurochemical etiology for this phenomenon.