Abstract | PURPOSE: MATERIALS AND METHODS: This was a double-blinded, randomized, placebo controlled crossover trial. Patients with benign prostatic hyperplasia and erectile dysfunction treated with the doxazosin gastrointestinal therapeutic system on a regular basis, with no other antihypertensive events, were recruited. Subjects took 10 mg vardenafil or placebo in a randomized crossover fashion with a washout period of at least 7 days between each treatment. The supine and standing blood pressure of the subjects was recorded from 1 hour before to 6 hours after the administration of vardenafil or placebo. The primary outcome of the study was the maximal change in standing systolic blood pressure of the subjects from 1 half hour before to 6 hours after the administration of drugs. RESULTS: A total of 37 patients, 25 (67.6%) and 12 (32.4%) on the doxazosin gastrointestinal therapeutic system at 4 mg and 8 mg, respectively, completed the trial. The combination drug therapy resulted in a maximal decrease in standing systolic blood pressure of 6.18 mm Hg (95% CI -12.02, -0.33; p = 0.039). Only 1 patient had an asymptomatic standing systolic blood pressure of less than 85 mm Hg. Otherwise no symptomatic hypotension or clinically significant adverse cardiovascular event was observed during the study. CONCLUSIONS:
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Authors | Chi-Fai Ng, Annie Wong, Chi-Wai Cheng, Eddie Shu-Yin Chan, Hon-Ming Wong, See-Ming Hou |
Journal | The Journal of urology
(J Urol)
Vol. 180
Issue 3
Pg. 1042-6
(Sep 2008)
ISSN: 1527-3792 [Electronic] United States |
PMID | 18639296
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Adrenergic alpha-Antagonists
- Imidazoles
- Phosphodiesterase Inhibitors
- Piperazines
- Placebos
- Sulfones
- Triazines
- Vardenafil Dihydrochloride
- Doxazosin
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Topics |
- Adrenergic alpha-Antagonists
(therapeutic use)
- Aged
- Analysis of Variance
- Blood Pressure
(drug effects)
- Cross-Over Studies
- Double-Blind Method
- Doxazosin
(therapeutic use)
- Drug Therapy, Combination
- Erectile Dysfunction
(complications, drug therapy)
- Humans
- Imidazoles
(therapeutic use)
- Male
- Middle Aged
- Phosphodiesterase Inhibitors
(therapeutic use)
- Piperazines
(therapeutic use)
- Placebos
- Prostatic Hyperplasia
(complications, drug therapy)
- Sulfones
(therapeutic use)
- Treatment Outcome
- Triazines
(therapeutic use)
- Vardenafil Dihydrochloride
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