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Vardenafil for erectile dysfunction: 2005 update

Clinical bottom line

Vardenafil has been studied in a large number of men. At the fixed doses of 10 or 20 mg or in a dose optimised regimen, it has considerable efficacy, with a number needed to treat of about 2. Headache (15%), flushing (13%), rhinitis (8%), and dyspepsia (4%), were the most common individual adverse events.


Reference

RA Moore et al. Indirect comparison of interventions using published randomised trials: Systematic review of PDE-5 inhibitors for erectile dysfunction. BMC Urology 2005 2005, 5:18.


Systematic review

Randomised trials were sought of three PDE-5 inhibitors (sildenafil, tadalafil, vardenafil), with placebo or active comparator, in men with erectile dysfunction of any causation, with drugs used at home. Previous systematic reviews were used to source trials or trial data, supplemented by electronic searches of PubMed (to June 2005, and supplemented by searches to November 2005 for this update) and the Cochrane Library (issue 1, 2005) using drug names and randomis(z)ed trial.

Information extracted was of efficacy, using a number of different efficacy outcomes, discontinuations, and specific adverse events. Almost all information was available for the 10 and 20 mg dose, and a dose optimised regimen; information was combined for 10 and 20 mg fixed dose, and for the dose optimised regimen.

Results

None of the trials used an active comparator, and most scored highly on reporting quality. All were randomised and double blind for inclusion in the review. Most of the studies used an enriched enrolment in which previous unsuccessful treatment with a PDE-5 inhibitor was an exclusion criterion.

Most studies were in men with erectile dysfunction of mixed aetiology, diabetes, or following prostatectomy. Studies were conducted mainly in Europe and North America.

Erectile function

With vardenafil 10/20 mg, the erectile function domain score rose to 20 (compared with 14 for placebo), an average 8-point change. Successful attempts at intercourse occurred 59% of the time, compared with 28% with placebo.

On average, in 3,379 men in 8 trials, 72% of men reported improved erections, compared with 24% with placebo (Figure 1). The number needed to treat for one man to have improved erections compared with placebo was 2.1 (95% confidence interval 1.9 to 2.2; Table 1).

Figure 1: Improved erections in comparisons of vardenafil and placebo

Table 1: Efficacy and adverse event outcomes in comparisons of vardenafil and placebo

Number of
Percent with
Outcome
Trials
Patients
Vardenafil
Placebo
Relative benefit or risk
(95% CI)
NNT/NNTp/NNH
(95%CI)
Efficacy
Improved erections
8
3379
72
24
3.1 (2.8 to 3.5)
2.1 (1.9 to 2.2)
Withdrawal
All-cause
5
2061
20
32
0.6 (0.5 to 0.6)
7.7 (6.0 to 11)
Lack of efficacy
6
2320
4
12
0.3 (0.2 to 0.4)
11 (9.0 to 16)
Adverse event
7
2868
3.3
1.8
1.8 (1.1 to 3.0)
65 (37 to 250)
Adverse events
All cause
insufficient data
Severe
3
1095
2.7
2.2
1.2 (0.5 to 2.8)
not calculated
Serious
5
1983
2.2
3.2
0.7 ( 0.4 to 1.2)
not calculated
Headache
6
2411
15
4.1
3.4 (2.4 to 4.8)
9.6 (7.9 to 12)
Dyspepsia
5
1969
3.8
0.3
7.3 (2.4 to 22)
31 (22 to 48)
Flushing
5
1982
13
0.8
13 (6.3 to 27)
8.0 (6.9 to 9.6)
Rhinitis
5
2211
7.9
3.6
2.2 (1.5 to 3.4)
23 (16 to 42)
NNT is given in standard font, NNTp in bold, and NNH inbold italic. No NNT/NNTp/NNH was calculated unless there was a statistically significant difference

 

Adverse events

All-cause discontinuation and lack of efficacy discontinuation were less frequent with vardenafil than placebo, but adverse event discontinuation more frequent. About 1% more men discontinued because of adverse events with vardenafil than with placebo (Table 1).

The proportion of men with at least one adverse event was not reported in these trials, but serious adverse events were no more common with vardenafil than with placebo. Headache (15%), flushing (13%), rhinitis (8%), and dyspepsia (4%), were the most common individual adverse events.

Comment

Vardenafil has been studied in a large number of men. At the fixed doses of 10 or 20 mg or in a dose optimised regimen, it has considerable efficacy, with a number needed to treat of about 2.