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Vardenafil for erectile dysfunction

 

Clinical bottom line

Vardenafil is effective in treating erectile dysfunction at doses between 5 and 20 mg. These doses were significantly better than placebo in producing erections hard enough for penetration, hard enough for penetration and of long enough duration for successful intercourse, and provided improved erections. Numbers needed to treat for improved erections were approximately 4 for vardenafil 5 mg, and 3 for vardenafil 10 mg and 20 mg.


Reference

S Markou et al. Vardenafil (Levitra) for erectile dysfunction: a systematic review and meta-analysis of clinical trial reports. International Journal of Impotence Research 2004 July doi:10.1038/sj.ijir.3901258 (online publications).


Background

Though a number of systematic reviews of sildenafil have been published in the years before 2004, systematic reviews and meta-analyses of the newer oral erectile dysfunction drugs in the same class (phosphodiesterase type 5 inhibitor) have not been until 2004. This at least opens the possibility of comparing and contrasting different treatments based on similar trials with similar outcomes.

Systematic review

A search strategy examined five electronic databases (including the Cochrane Library) and FDA records and European equivalents. Trials were eligible if they were randomised trials in men with erectile dysfunction comparing vardenafil with placebo, were at least 12 weeks in duration and assessed clinical outcomes of erectile dysfunction.

Results

Men in the trials had a mean age of 56 years, and the mean duration of erectile dysfunction was 3.8 years. Erectile dysfunction severity was mild-moderate in 51% and severe in 46%. Organic erectile dysfunction was present in 55% of men, psychogenic in 12% and mixed in 33%. Comorbid conditions included hypertension (36%), diabetes (38%) and depression (23%).

Efficacy

Vardenafil was used at 5, 10, and 20 mg. Flexible dosing was used in only one trial. Table 1 shows the results for the three doses. All were significantly better than placebo in producing erections hard enough for penetration, hard enough for penetration and of long enough duration for successful intercourse, and provided improved erections (Table 1). Numbers needed to treat for improved erections were approximately 4 for vardenafil 5 mg, and 3 for vardenafil 10 mg and 20 mg.

Table 1: vardenafil in erectile dysfunction

 
Percent with
 
Vardenafil 5 mg
Placebo
NNT
(95%CI)
Q2: Effective penetration
+20
not given
5
Q3: Successful intercourse
+24
not given
4
Improved erections
50
26
4
 
Vardenafil 10 mg
Placebo
NNT
(95%CI)
Q2: Effective penetration
+26
not given
4
Q3: Successful intercourse
+31
not given
3
Improved erections
57
26
3
 
Vardenafil 20 mg
Placebo
NNT
(95%CI)
Q2: Effective penetration
+29
not given
3
Q3: Successful intercourse
+32
not given
3
Improved erections
58
26
3
Note that figures are weighted mean difference as a percentage, or percent. NNTs are imputed, since numbers of patients were not given for each dose

 

Harm

Discontinuations occurred in 3-5% of men on vardenafil, compared with 2% on placebo. Men experiencing any adverse event rose in a dose-dependent manner, from 29% at 5 mg to 56% on 20 mg. The most common adverse events were headache (14-19%), flushing (7-14%), rhinitis-sinusitis (8-15%) and dyspepsia (1-5%).

Comment

This review claims to use clinical trial reports, but actually uses published studies. Clinical trial reports connotes the internal reports from pharmaceutical companies, which contain considerably more information than do published reports, for the simple reason that there is no limitation on space. The analysis is limited, and the raw information needed, for instance, to calculate NNTs is not present. At the highest dose the percentage of men with improved erections (58%) is somewhat less than that seen at higher doses of sildenafil or tadalafil, though there may be somewhat more men with more severe erectile dysfunction.