In a nutshell
This study examined the safety and effectiveness of long-term daily administration of udenafil (Zydena) for erectile dysfunction. Researchers reported high effectiveness with a low rate of side effects.
Some background
Drug therapy with phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil (Viagra) and udenafil (Zydena), are often the first-line treatment for erectile dysfunction. PDE5 inhibitors increase blood flow to the penile arteries and help achieve an erection for sexual intercourse. They can be administered on demand (as needed) or once daily. A number of studies have suggested an advantage of daily administration over administration on demand for mild to moderate erectile dysfunction. Udenafil is a newly developed PDE5 inhibitor. More studies are needed to examine the safety and effectiveness of long-term daily administration of udenafil.
Methods & findings
302 men with erectile dysfunction were included in this study. Most men had moderate erectile dysfunction, on average for 5.3 years. All men had received udenafil (75 mg) once daily for 24 weeks and were assigned to receive another 24 weeks of udenafil (also 75 mg once daily). Erectile dysfunction was measured before, during, and 4 weeks after treatment.
24 weeks of udenafil significantly improved erectile function compared to before treatment. Erectile function continued to improve significantly between Week 24 and Week 48. A decrease in erectile function was observed after the 4-week treatment-free period.
95.4% of men reported improved erectile function with treatment. Almost half of the men (45.1%) reported normal erectile function at the end of treatment (at 48 weeks). This reduced to 14.2% of men 4 weeks after the end of treatment.
8% of men experienced side effects. Hot flushes and headache were among the most common. Most side effects were considered mild.
The bottom line
Researchers concluded that daily udenafil is a safe and effective long-term treatment of erectile dysfunction. Daily PDE5 inhibitor use may allow for a more spontaneous sex life.
The fine print
Undenafil has not been approved for use by the US Food and Drug Administration (FDA).
Published By :
The journal of sexual medicine
Date :
Jun 17, 2016
