Beste apotheek van Nederland

Oral Treatments — Phosphodiesterase Type 5 (PDE–5)
Inhibitors – Vardenafil
Literature Search
In total, 22 unique randomized controlled trials (RCTs) (31 publications) met the eligibility
criteria and were included in the review. 180-210 (see also summary Evidence Table F-2, Appendix
F) Seven unique trials were reported in more than one publication. The following list shows the
reference identifications for these trials and corresponding publications (each row).
The first reference (author, year, citation) denotes the primary publication (i.e., reporting the
most relevant and complete data for the trial), which is used to designate the trial throughout the
Vardenafil section.
1. Valiquette 2005 182 and Valiquette 2006 202
2. Nehra 2005 183 and Brock 2003 187
3. Carson 2005 184 and Hatzichristou 2005 188
4. Hatzichristou 2004 191 and Hatzichristou 2005 207
5. Porst 2001 194 and Porst 2003 185
6. Goldstein 2005 197 and Fisher 2005 186
7. Hellstrom 2002, 192 Hellstrom 2003, 208 Hellstrom 2005, 209 and Donatucci 2004 210
Overview of Trials
The trials were conducted in North America, 181-184,190,190,192,192,197,197-199,199,203 Europe, 184,190,
191,193-201,203,204 South America, 182,190,203 and Asia. 180,182,184,189,203,203,205,206
Of the 22 trials, two were of crossover design 193,195 and the remaining 20 trials used parallelarm
design. All but one (active arm-controlled) 190 were placebo-controlled trials.
The trials were supported by Bayer 181,183,189,190,192-195,197,198,200,201,203,205 Bayer and
GlaxoSmithKline, 182,184,191,196,199 and GlaxoSmithKline. 204 Funding sources could not be
ascertained for two trials. 180,206
Populations
The included trials involved participants diagnosed with ED. The total and mean numbers of
patients randomly assigned to an intervention or placebo across the 22 trials were 8,621 and 392,
respectively, while the number of randomly assigned patients in each trial ranged from 21 193 to
1020. 190
The inclusion criteria across most of the included trials were: adult males aged ≥18 years,
diagnosed with ED for ≥ 6 months in a stable monogamous heterosexual relationship. 180-184,189­
195,197-201,203,204 In one trial, 205 the inclusion criteria for the patients’ age and duration of ED were
slightly different (≥20 and ≥5 years, respectively). In the report of one trial 206 the patient
inclusion criteria for age and duration of ED were not clear.
The additional inclusion criteria in seven trials were diagnoses for the following conditions:
diabetes types I or II, 181,205 diabetes type I, 204 nerve-sparing retropubic prostatectomy, 183 history
of renal transplant, 206 untreated mild major depressive disorder, 199 or arterial hypertension. 196
One trial included ED patients who had not responded to previous sildenafil therapy. 184 In three
trials, the included patients were sildenafil-naïve. 180,201,204 In one of these trials, 180 patients had
not received any previous treatment for ED.
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