Up‐titration of vardenafil dose from 10 mg to 20 mg improved erectile function in men with spinal cord injury

Abstract

Aim: Vardenafil is a highly selective phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction (ED). Efficacy of vardenafil has been demonstrated in various ED populations, but that in Japanese patients with spinal cord injury (SCI) has not been assessed. Methods:This was an open-label, multicenter, flexible dose, 12-week study in patients with ED due to SCI. Following a 4-week observation period, patients received vardenafil 10 mg for 4 weeks, and based on efficacy, tolerability and patient preference, doses for the remaining 8 weeks were decided by investigators. The primary efficacy parameter was erectile function domain score of the International Index of Erectile Function. Results: Ten patients took 10 mg all through the study, while 22 patients took 20 mg after completing 4 weeks' treatment with 10 mg. The erectile function domain score increased from 12.2 at baseline to 25.0 at Last Observation Carried Forward (LOCF) in the former group and from 10.3 to 22.5 in the latter group, respectively. Importantly, there was a 5.0 point increase in erectile function domain score after up-titration in the latter group. Drug-related adverse events were observed in 22% of patients including hot flushes (9%) and headache (6%), but these were transient and mild in intensity. Serious adverse events and adverse events leading to discontinuation of the study drug were not reported. Conclusions: Vardenafil 10 and 20 mg was well tolerated and improved erectile function in patients with SCI. Of interest, erectile function was further improved by 20 mg in patients who were not sufficiently treated with 10 mg.

Efficacy and safety of phosphodieterase-5 inhibitors for treatment of erectile dysfunction secondary to spinal cord injury: a systemic review and meta-analysis

“…18 PDE5 inhibitors have also changed the treatment of ED in SCI patients, becoming the preferred treatment in subjects with SCI since the introduction of sildenafil because of their ease of use and effectiveness. [19][20][21] Nevertheless the role of PDE5 inhibitors to treat ED caused by SCI has not been well assessed. It is still challenging to identify the efficacy and safety of PDE5 inhibitors in SCI patients suffering from ED.…”

Efficacies of papaverine and sildenafil in the treatment of erectile dysfunction in early-stage paraplegic men

“…Existing evidence suggests that PDE-5 inhibitors are a highly effective and well-tolerated treatment for ED with SCI. Treatment with PDE-5 inhibitors can significantly improve key quality of life parameters in men with ED caused by SCI (Giuliano et al, 1999(Giuliano et al, , 2006(Giuliano et al, , 2007(Giuliano et al, , 2008Maytom et al, 1999;Hultling et al, 2000;Sánchez Ramos et al, 2001;Kimoto et al, 2006;Lombardi et al, 2009). To our knowledge, we did not come across any study related to the use of vasoactive agents in the early stage after injury including the first 6 months as inclusion criteria.…”

“…rigid, or long lasting to enable satisfactory sexual intercourse (Yarkony, 1990;Ducharme et al, 1993). The mean duration of the disease was found to be between 2 and 19.7 years in the literature related to the use of vasoactive agents in patients with SCI (Giuliano et al, 1999(Giuliano et al, , 2006(Giuliano et al, , 2007(Giuliano et al, , 2008Maytom et al, 1999;Hultling et al, 2000;Sánchez Ramos et al, 2001;Kimoto et al, 2006;Lombardi et al, 2009). There was only one study that evaluated the patients with SCI ranging from as early as 6 months to a maximum of 1 year after the injury (Del Popolo et al, 2004).…”

Erectile Dysfunction in Paraplegic Males

“…In the same study, 59% of the vardenafil group indicated satisfactory duration of erection, compared to 22% of the placebo group. Another open label study, without control, dealing with vardenafil administration in SCL patients, based on 38 patients, indicated achievement of erection, efficient for penetration in 83% of patients and duration of erection satisfactory for 88% of those (Kimoto et al, 2006).…”