Beste apotheek van Nederland

In most trials, patients had ED with a broad spectrum of causes (i.e., organic, psychogenic,
and mixed). 180,182,184,189-195,197,198,200,201,203 The mean age across the 22 trials ranged from 34
years 195 to 60 years. 183,184
Exclusion criteria were not reported for two trials. 180,200 Patients with the following
conditions were excluded from the trials: primary hypoactive sexual desire 181-184,190-193,196-199,201,
203-205 penile/genital anatomical deformity, 182,184,189-192,195-199,201,203,204,206 any medical psychiatric
or substance abuse disorder affecting the ability to complete the study, 182,184,189,199,201,205 ED
resulting from spinal cord injury, 181-184,189-199,201,203-205 cardiovascular conditions (e.g. coronary
artery disease, myocardial infarction, electrocardiographic ischemia, life-threatening arrhythmia,
stroke, uncontrolled atrial tachyarrhythmia, unstable angina pectoris, uncontrolled atrial
fibrillation), 181-184,189-193,195-198,201,203-206 hyper/hypotension (resting), 181-184,189-193,195,196,201,203-206
postural hypotension, 182,183,189,192,196,201,204,205 liver disease, 181,183,189,191,192,196,198,201,204-206 radical
prostatectomy, 190-199,201,203-205 bleeding or hematological disorder, 181,183,189,191,192,198,201,203,204,206
retinitis pigmentosa, 181-183,190,192,193,195-199,203-205 poorly controlled diabetes mellitus, 182,183,189-195,
198,203 hepatitis B, 189,192,194,195,198,203 hepatitis C, 189,192,194,196,201,204 peptic ulceration, 183,189,192,201,205,
206 major psychiatric disorders, 193,195,199 endocrine diseases, 193,195 autonomic neuropathy, 181 or
prostate cancer. 183
The following concomitant medications were not allowed: nitrates or nitric oxide donors, 181­
184,189,191-198,201,203-206 cimetidine, erythromycin, ketoconazole or trazodone, current use of digoxin
derivatives or digitoxin antiarrhythmics, 189,192,194,196-198,201,204 anticoagulants, 181-183,192,194,196-198,201,
204 androgens, 192,196-198,201,203,204 ketoconazole, 194,196,197,204 alpha blockers, 196-198,201 or
rifampicin. 189,194
182-184, 189,192,194,
Patients with abnormal hormone profiles such as low serum total testosterone, 201,203 elevated serum creatinine, 184,189,192,196,201,203,204 serum free thyroxine (T4) out of the normal
range, 189 or thyroid-stimulating hormone (TSH) below the normal range were also
excluded. 189,194
Also excluded were sildenafil nonresponders 189-194,198,199,203 and patients who had
discontinued previous sildenafil treatment because of side effects. 181,183,189-191,198
Interventions
The patients in all 22 included trials were randomly assigned to receive monotherapy of oral
vardenafil at either a fixed or a flexible dose. In 12 trials, 180-183,189,190,192-195,198,205 vardenafil was
administered at a fixed dose ranging from 5 mg/d 189,192,194 to 40 mg/d, 193 whereas in the
remaining 10 trials a flexible dose with upward and downward titration was used, depending on
the observed response in terms of efficacy and tolerability (i.e., 10 mg/d, 5 mg/d, 20
mg/d). 184,191,196,197,199-201,203,204,206
The patients were randomly assigned to receive placebo in all but one trial, 190 in which two
doses (10 mg/d and 20 mg/d) of vardenafil were compared. In one trial the study medication (i.e.,
vardenafil) was coadministered with visual sexual stimulation. 195
In 10 trials patients were randomly assigned to receive two or more different fixed doses of
vardenafil in each arm: 10 mg/d versus 20 mg/d, 181,183,190,195,198,205 5 mg/d versus 10 mg/d versus
20 mg/d, 189,192,194 and 20 mg versus 40 mg. 193
In the majority of included trials, the duration of treatment with vardenafil was about 12
weeks. 181-184,189,194,211 The treatment duration across the trials ranged from 4 weeks 198,206 to 24
months. 190
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